CRITERIA FOR ACCEPTABILITY OF RADIOLOGICAL, NUCLEAR MEDICINE AND by broverya72

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									R A D I AT I O N C R I T E R I A F O R
     A C C E P TA B I L I T Y O F
 MEDICAL RADIOLOGICAL
    EQUIPMENT USED IN
D I A G N O S T I C R A D I O L O G Y,
NUCLEAR MEDICINE AND
        RADIOTHERAPY
  FINAL DRAFT AMENDED-V1.4-091001




           EUROPEAN COMMISSION
    CONTRACT NO. TREN/07/NUCL/S07.70464
Radiation Criteria For Acceptability Of Radiological, Nuclear Medicine And Radiotherapy Equipment




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Radiation Criteria For Acceptability Of Radiological, Nuclear Medicine And Radiotherapy Equipment



                                              CONTENTS

CONTENTS _________________________________________________________________ 3
1.     INTRODUCTION _________________________________________________________ 5
     1.1.   Purpose and Background____________________________________________________ 5
     1.2.   Basis for Criteria of Acceptability in European Directives __________________________ 7
       1.2.1.   Requirements of the Medical Exposure Directive_____________________________________7
       1.2.2.   Wider context, the MDD Directive and Equipment Standards ___________________________9
     1.3.   To whom this document is addressed ________________________________________ 11
     1.4.   Criteria of Acceptability ____________________________________________________ 12
       1.4.1.   Approaches to Criteria_________________________________________________________12
       1.4.2.   Suspension Levels ____________________________________________________________13
       1.4.3.   Identifying and Selecting Criteria ________________________________________________15
     1.5.   Special Considerations, Exceptions and Exclusions ______________________________ 17
       1.5.1.   Special Considerations_________________________________________________________17
       1.5.2.   Exceptions __________________________________________________________________18
       1.5.3.   rapidly evolving technologies ___________________________________________________18
       1.5.4.   Exclusions___________________________________________________________________19
     1.6.   Establishing criteria of acceptability have been met _____________________________ 19
2.     DIAGNOSTIC RADIOLOGY ________________________________________________ 22
     2.1.   Introduction _____________________________________________________________ 22
     2.2.   X-Ray Generators and equipment for General Radiography_______________________ 23
       2.2.1.   Introduction _________________________________________________________________23
       2.2.2.   Criteria for X-Ray Generators, and General Radiography ______________________________26
     2.3.   Radiographic Image Receptors and Viewing Facilities____________________________ 29
       2.3.1.   Introduction _________________________________________________________________29
       2.3.2.   Criteria for Image Receptors and Viewing Facilities __________________________________31
     2.4.   Mammography___________________________________________________________ 37
       2.4.1.   Introduction _________________________________________________________________37
       2.4.2.   Measurements_______________________________________________________________38
     2.5.   Dental Radiography _______________________________________________________ 41
       2.5.1.   Introduction _________________________________________________________________41
       2.5.2.   Intra-Oral Systems ____________________________________________________________41
       2.5.3.   Criteria for Dental Radiography__________________________________________________42
       2.5.4.   Panoramic radiography ________________________________________________________43
       2.5.5.   Cephalometry _______________________________________________________________43
     2.6.   Fluoroscopic Systems______________________________________________________ 44
       2.6.1.   Introduction _________________________________________________________________44
       2.6.2.   Criteria for Acceptability of Fluoroscopy Equipment _________________________________45
     2.7.   Computed Tomography____________________________________________________ 46
       2.7.1.   Introduction _________________________________________________________________46
       2.7.2.   Criteria for Acceptability of CT Systems ___________________________________________48
     2.8.   Dual Energy X-ray Absorptiometry ___________________________________________ 49
       2.8.1.   Introduction _________________________________________________________________49
       2.8.2.   Acceptability Criteria for DXA Systems ____________________________________________49



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3.     NUCLEAR MEDICINE EQUIPMENT__________________________________________ 50
     3.1.    Introduction _____________________________________________________________ 50
     3.2.    Nuclear Medicine Therapeutic Procedures ____________________________________ 52
       3.2.1.     Introduction _________________________________________________________________52
       3.2.2.     Activity Measurement Instruments_______________________________________________53
       3.2.3.     Contamination Monitors _______________________________________________________53
       3.2.4.     Patient Dose Rate Measuring Instruments _________________________________________54
       3.2.5.     Radiopharmacy Quality Assurance Programme _____________________________________55
     3.3.    Radiopharmacy for Gamma Camera based Diagnostic Procedures _________________ 56
       3.3.1.     Introduction _________________________________________________________________56
       3.3.2.     Activity Measurement Instruments_______________________________________________57
       3.3.3.     Gamma Counters _____________________________________________________________57
       3.3.4.     Thin Layer Chromatography Scanners_____________________________________________58
       3.3.5.     Contamination monitors _______________________________________________________58
     3.4.    Radiopharmacy for Positron Emission Based Diagnostic Procedures________________ 59
     3.3     Gamma Camera based Diagnostic Procedures__________________________________ 59
       3.3.1    Introduction ___________________________________________________________________59
       3.4.1.      Planar Gamma Camera ________________________________________________________60
       3.4.2.      Whole Body IMAGING System___________________________________________________61
       3.4.3.      SPECT System________________________________________________________________62
       3.4.4.      Gamma Cameras used for Coincidence Imaging_____________________________________63
     3.5.    Positron Emission Diagnostic Procedures______________________________________ 64
       3.5.1.     Introduction _________________________________________________________________64
       3.5.2.     Positron Emission Tomography System ___________________________________________65
       3.5.3.     Hybrid Diagnostic Systems______________________________________________________66
     3.4     Intra-Operative Probes ____________________________________________________ 67
4      RADIOTHERAPY ________________________________________________________ 69
     3.6.    Introduction _____________________________________________________________ 69
     3.3     Linear accelerators________________________________________________________ 70
     3.7.    Simulators_______________________________________________________________ 73
     3.8.    CT Simulators ____________________________________________________________ 76
     3.9.    Cobalt-60 units ___________________________________________________________ 79
     3.10.      Kilovoltage Units _______________________________________________________ 81
     3.11.      Brachytherapy _________________________________________________________ 82
     3.12.      Treatment Planning Systems______________________________________________ 83
     3.13.      Dosimetry Equipment ___________________________________________________ 84
     3.14.      Radiotherapy Networks__________________________________________________ 85
APPENDIX 1 INFORMATIVE NOTE ON IMAGING PERFORMANCE_____________________ 88
APPENDIX 2 AUTOMATIC EXPOSURE CONTROL __________________________________ 89
APPENDIX 3 EQUIPMENT ____________________________________________________ 90
REFERENCES & SELECTED BIBLIOGRAPHY _______________________________________ 92
ACKNOWLEDGEMENTS_____________________________________________________ 103

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 1                                           1. INTRODUCTION


 2       1.1. PURPOSE AND BACKGROUND


 3   The purpose of this publication is to specify minimum performance standards for
 4   radiological, nuclear medicine and radiotherapy equipment. The criteria of
 5   acceptability presented here are based on levels of performance that prompt
 6   intervention and will result in the use of the equipment being curtailed or terminated,
 7   if not corrected. The criteria are produced in response to Directive 97/43/Euratom,
 8   which requires that medical exposures be justified and carried out in an optimized
 9   fashion. To give effect to this Directive, Article 8.3 stipulates that Member States
10   shall adopt criteria of acceptability for radiological equipment in order to indicate
11   when action is necessary, including, if appropriate, taking the equipment out of
12   service. In 1997, the Commission published Radiation Protection 91: Criteria for
13   acceptability      of   radiological      (including      radiotherapy)       and     nuclear       medicine
14   installations (EC, 1997), in pursuit of this objective. This specified minimum criteria
15   for acceptability and has been used to this effect in legislation, codes of practice and
16   by individual professionals throughout the member states and elsewhere in the world.

17   RP 91 considered diagnostic radiological installations including conventional and
18   computed tomography, dental radiography, and mammography, radiotherapy
19   installations and nuclear medicine installations.                   However, development of new
20   radiological systems and technologies, improvements in traditional technologies and
21   changing clinical/social needs have created circumstances where the criteria of
22   acceptability need to be reviewed to ensure the principles of justification and
23   optimization are upheld. To give effect to this, the Commission, on the advice of the
24   Article 31 Group of Experts, initiated a study aimed at reviewing and updating RP 91
25   (EC, 1997), which in due course has led to this publication.

26   This revised publication is, among other features, intended to:

27   1. Update existing acceptability criteria.

28   2. Update and extend acceptability criteria to new types of installations. In diagnostic
29       radiology, the range and scope of the systems available has been greatly

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 1       extended (e.g. computed radiography, digital radiography, digital fluoroscopy,
 2       multislice computed tomography (CT) and dual energy x-ray absorptiometry
 3       (DXA)). In nuclear medicine, there are Positron Emission Tomography (PET)
 4       systems and hybrid scanners. In radiotherapy, there are linear accelerators with
 5       multileaf collimators capable of intensity modulated radiotherapy (IMRT).

 6   3. Identify an updated and more explicit range of techniques employed to assess
 7       criteria of acceptability,

 8   4. Provide criteria that have a reasonable opportunity of being accepted, and that
 9       are achievable throughout the member states.

10   5. Deal, where practical, with the implications for screening techniques, paediatrics,
11       high dose techniques and other special issues noted in the 1997 Directive.

12   6. Promote approaches based on an understanding of and that attempt to achieve
13       consistency with those employed by the Medical Devices Directive (MDD)
14       (Council Directive 93/42/EEC), industry, standards organizations and professional
15       bodies.

16   7. Make practical suggestions on implementation and verification.

17   To achieve this, the development and review process has involved a wide range of
18   individuals     and     organizations,       including      experts     from     relevant      professions,
19   professional bodies, industry, standards organizations and relevant international
20   organizations. It was easier to achieve the last objective with radiotherapy than with
21   diagnostic radiology. This is because of a long tradition of close working relationships
22   between the medical physics and international standards communities, which has
23   facilitated the development and adoption of common standards in radiotherapy. An
24   attempt has been made, with the cooperation of the International Electrotechnical
25   Commission (IEC), to import this approach to the deliberations on diagnostic
26   radiology and to extend it, where it already exists, in nuclear medicine.

27   The intent has been to define parameters essential to the assessment of the
28   performance of radiological medical installations and set up tolerances within which
29   the technical quality and equipment safety standards for medical procedures are

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 1   ensured. The methods for performance assessment recommended generally rely on
 2   non-invasive measurements open to the end user. This publication will benefit the
 3   holder of radiological installations, bodies responsible for technical surveillance and
 4   authorities charged with verifying compliance of installations with regulations on
 5   grounds of technical safety. However, it is important to bear in mind that the present
 6   publication follows the precedent established in RP 91, is limited to the equipment
 7   and does not address wider issues such as those associated with, for example, the
 8   requirements for buildings and installations, information technology (IT) systems such
 9   as picture archiving and communication systems (PACS) and/or radiological
10   information systems (RIS).

11       1.2. BASIS FOR CRITERIA OF ACCEPTABILITY IN EUROPEAN DIRECTIVES

12           1.2.1.REQUIREMENTS OF THE MEDICAL EXPOSURE DIRECTIVE


13   The work of the European Commission in the field of radiation protection is governed
14   by the Euratom Treaty and the Council Directives made under it.                                     The most
15   prominent is the Basic Safety Standards Directive (BSS) on the protection of
16   exposed workers and the public (Council Directive 80/836/Euratom), revised in 1996
17   (Council Directive 96/29/Euratom).                Radiation protection of persons undergoing
18   medical examination was first addressed in Council Directive 84/466/Euratom. This
19   was replaced in 1997 by Council Directive 97/43/EURATOM (MED) on health
20   protection of patients against the dangers of ionizing radiation in relation to medical
21   exposure. This prescribes a number of measures to ensure medical exposures are
22   delivered under appropriate conditions. It makes necessary the establishment of
23   quality assurance programmes and criteria of acceptability for equipment and
24   installations. These criteria apply to all installed radiological equipment used with
25   patients.

26   The directive also deals with the monitoring, evaluation and maintenance of the
27   required characteristics of performance of equipment that can be defined, measured
28   and controlled. In particular, it requires that all doses arising from medical exposure
29   of patients for medical diagnosis or health screening programmes shall be kept as
30   low as reasonably achievable consistent with obtaining the required diagnostic



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 1   information, taking into account economic and social factors (ALARA). Specifically,
 2   the requirements in respect of criteria of acceptability are stated as follows:

 3   “Competent authorities shall take steps to ensure that necessary measures are taken
 4   by the holder of the radiological installation to improve inadequate or defective
 5   features of the equipment. They shall also adopt specific criteria of acceptability for
 6   equipment in order to indicate when appropriate remedial action is necessary,
 7   including, if appropriate, taking the equipment out of service.”

 8   Additional requirements in respect of image intensification and dose monitoring
 9   systems are explicitly specified. These extend to all new equipment which:

10   “shall have, where practicable, a device informing the practitioner of the quantity of
11   radiation produced by the equipment during the radiological procedure.”

12   Finally Article 9 requires that:

13   “Appropriate radiological equipment ----- and ancillary equipment are used for the
14   medical exposure

15       •   of children,

16       •   as part of a health screening programme,

17       •   involving high doses to the patient, such as interventional radiology, computed
18           tomography or radiotherapy.”

19   And that:

20   “Special attention shall be given to the quality assurance programmes, including
21   quality control measures and patient dose or administered activity assessment, as
22   mentioned in Article 8, for these practices.”

23   Practical consequences of these requirements are that:




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 1       1. Acceptance testing must be carried out before the first use of the equipment
 2           for clinical purposes to ensure it complies with its performance specification
 3           and to provide reference values for future performance testing.

 4       2. Further performance testing must be undertaken on a regular basis, and after
 5           any major maintenance procedure.

 6       3. Necessary measures must be taken by the holder of the radiological
 7           installation to improve inadequate or defective features of the equipment.

 8       4. Competent authorities must adopt specific criteria of acceptability for
 9           equipment in order to indicate when appropriate action is necessary, including
10           taking the equipment out of service.

11       5. Appropriate quality assurance programmes including quality control measures
12           must be implemented by the holder of the radiological installation.

13   This publication deals with the first four points and will be germane to some aspects
14   of the fifth. It updates and extends the advice provided in 1997 in RP 91 (EC, 1997).
15   However, this document is not intended to act as a guide to quality assurance or
16   quality control programmes, which are comprehensively dealt with elsewhere (CEC
17   2006; APPM 2006a, b; IPEM 2005a, b; AAPM 2002; BIR 2001; Seibert 1999; IPEM,
18   1997a, b, c).

19           1.2.2.WIDER CONTEXT, THE MDD DIRECTIVE AND EQUIPMENT STANDARDS


20   Since 1993, safety aspects of design, manufacturing and placing on the market of
21   medical devices are dealt with by MDD. It is managed by the European Directorate
22   General Enterprise; its main goal is to define and list the Essential Requirements,
23   which must be fulfilled by Medical Devices. When such a device is in compliance
24   with the Essential Requirements of the MDD, it can be “CE marked”, which opens the
25   full European market to the product.

26   There are a number of ways with which manufacturers can demonstrate that their
27   products meet the Essential Requirements of the MDD; the one of most interest here
28   involves international standards.              Further, demonstration of conformity with the


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 1   essential requirements must include a clinical evaluation. Any undesirable side-
 2   effects must constitute an acceptable risk when weighted against the performance
 3   intended.       For the types of system that are the subject of this publication,
 4   demonstration of the essential requirements can be achieved by the procedures
 5   described in the directive annexes. Conformity of all or part of these requirements
 6   can be demonstrated or verified through compliance with harmonised international
 7   standards. These are standards that specify essential requirements for the basic
 8   safety and essential performance of the device, such as those issued by the IEC or
 9   Comité Européen de Normalisation Electrotechnique (CENELEC).

10   Although the MDD includes requirements for devices emitting ionising radiation, this
11   does not affect the authorisations required by the directives adopted under the
12   Euratom treaty when the device is brought into use. In this regard, the Euratom
13   Treaty directives have precedence over the MDD.                          Conformity with an IEC or
14   CENELEC standard will frequently be included as part of the suppliers’ specification
15   and will be confirmed during contractual acceptance (acceptance testing) of the
16   equipment by the purchaser. On the other hand the acceptability criteria in this
17   publication must be met during the useful life of the equipment and its compliance
18   with them will generally be regularly assessed.

19   The MDD was substantially amended by Directive 2007/47/EC. The amendments
20   include an undertaking by the manufacturer to institute and keep up to date a
21   systematic procedure to review experience gained from devices in the post-
22   production phase and to implement appropriate means to apply any necessary
23   corrective action.        Furthermore, the clinical evaluation and its documentation must
24   be actively updated with data obtained from the post-market surveillance. Where
25   post-market clinical follow-up as part of the post-market surveillance plan for the
26   device is not deemed necessary, this must be duly justified and documented.

27   In transposing these European directives into national law, the acceptability criteria
28   required by the MED may be transposed into national law using country specific
29   criteria and approaches. It is clear that this may undermine the applicability essential
30   performance standards as required by the MDD or through compliance with the
31   international standardisation system. Such an approach conflicts with the concept of
32   free circulation and suppression of barriers to trade, which is one of the goals of the

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 1   EU in general and the MDD in particular. To avoid these difficulties there is an
 2   urgent and clear need for harmonisation between the requirements of the two
 3   directives (MDD and MED). Thus it is desirable that all EU countries both transpose
 4   the MED requirement for criteria of acceptability in a consistent fashion that will not
 5   harm the efforts under the MDD, the standards and CE marking systems, to ensure
 6   free circulation of goods and suppress trade barriers. The approach advocated in
 7   this publication is consistent with this objective.

 8   Thus, care must be exercised transposing the requirements of the MED based on
 9   either partial or inappropriate adoption of this publication as national legislation.
10   Where this is envisaged, some caution is necessary and due discretion must be
11   allowed in respect of the clinical situations envisaged in this introduction and the
12   associated technology specific sections. Furthermore, adopting a regulation based
13   solely on national radiation protection considerations without due regard for the
14   issues arising from the MDD is likely to prove counterproductive for both suppliers
15   and end users. At a national level, the solution adopted should ensure patient safety
16   while fostering a cooperative framework between industry, standards, end users and
17   regulators. Internationally, there is a clear need for harmonization and a level of
18   uniformity between countries in recognition of the global nature of the equipment
19   supply industry. It is further necessary that there be harmonization between industry
20   and users, at least in terms of the methodologies employed.

21       1.3. TO WHOM THIS DOCUMENT IS ADDRESSED


22   Regulatory documents and standards, with respect to equipment performance, can
23   be addressed to or focused primarily on the needs or obligations of a particular
24   group. For example, the standards produced by IEC and CENELEC are primarily
25   aimed at manufacturers and suppliers. Many of the tests they specify are type tests
26   that could not be done in the field.

27   However, the possible audiences for this publication include holders, end users,
28   regulators, industry and standards organizations. It is recognized that each of these
29   has a necessary interest in this publication and its application. It was recognized that
30   the primary audience for the publication is the holders and end-users of the
31   equipment       (specifically,      the    health     agencies,       hospitals,      other     institutions,

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 1   practitioners, medical physicists and other staff and agents, who deploy the
 2   equipment for use with patients). In addition, it was recognized that it must reflect the
 3   requirements of regulators when they are acting in the medical area in the interests
 4   of end users and/or patients.                        This is in keeping with the precedent implicitly
 5   established through the scope and format adopted for RP 91.                                               This publication
 6   addresses the needs of these groups while taking due account of the reality of
 7   globalization of the industry, standards and the harmonization objectives viz a viz the
 8   MDD noted elsewhere. The technical parts of Sections 2, 3, and 4 assume those
 9   reading and using them are familiar with this introduction and have a good working
10   knowledge of the relevant types of equipment and appropriate testing regimes.

11         1.4. CRITERIA OF ACCEPTABILITY

12             1.4.1.APPROACHES TO CRITERIA


13   Approaches to describing the acceptability and performance of equipment have
14   varied. They inevitably include requirements specifically prescribed in the directive,
15   such as:

16   “In the case of fluoroscopy, examinations without an image intensification or
17   equivalent techniques are not justified and shall therefore be prohibited”,

18   or,

19   “Fluoroscopic examinations without devices to control the dose rate shall be limited
20   to justified circumstances.”

21   With respect to other areas, they range from provision of hard numerical values for
22   performance indices to detailed specification of measurement methodologies without
23   indicating the performance level to be accepted. The latter approach has come to be
24   favoured in many of the standards issued by bodies like IEC or CENELEC and by
25   some professional bodies.1                      While this approach has the advantage that it is

     1
       The IEC is the world's leading organization that prepares and publishes International Standards for all electrical, electronic and
     related technologies. IEC standards cover a vast range of technologies, including power generation, transmission and
     distribution to home appliances and office equipment, semiconductors, fibre optics, batteries, and medical devices to mention
     just a few. Many, if not all, of the markets involved are global. Within the EU CENELEC is the parallel standards organization
     and in practice adopts many IEC standards as its own aligning them within the European context.




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 1   easier/possible to get consensus on it among the manufacturers, professions and
 2   other interests involved, it also has some disadvantages. These include an evident
 3   lack of transparency, associated limitations on accountability and risks of
 4   misapplication in the hands of inexperienced users.

 5   A comprehensive, consistent suite of approaches to performance and safety
 6   assessment of radiological equipment has been proposed by the UK Institute of
 7   Physics and Engineering in Medicine (IPEM, 2005a, b; IPEM, 1997a, b, c]. The
 8   American Association of Physics in Medicine (AAPM,, 2006a, b, 2005, 2002) and
 9   British Institute of Radiology (BIR, 2001) have also, among other professional
10   organizations, published much useful material. The IPEM system is based on the
11   assumption that deviations from the baseline performance of equipment on
12   installation will provide an adequate means of detecting unsafe or inadequately
13   performing equipment. This approach is questionable within the meaning of criteria
14   of acceptability in the MED; if the baseline is, for one reason or another,
15   unsatisfactory, there are no criteria on which it can be rejected. In light of this issue,
16   the approach more recently favoured by IPEM and many standards organizations
17   has not been adopted in most instances. Where possible, the emphasis has been to
18   propose firm suspension levels. This is consistent with the approach adopted in
19   many countries, including, for example, France, Germany, Belgium, Spain, Italy,
20   Luxembourg and others which have adopted hard limits for performance values
21   based on RP 91 or other sources.

22           1.4.2.SUSPENSION LEVELS


23   A critical reading of the directive, RP 91 and the professional literature reveals some
24   shift or “creep” in the meaning of the terms remedial and suspension level since they
25   came into widespread use in the mid 1990s.                      In the interest of clarity, we have
26   redefined them in a way that is consistent with both their usage in the Directive and
27   their current usage, as follows:

28   Definition of Suspension Levels:

29   A level of performance that requires the immediate removal of the equipment
30   from use.


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 1   Following a documented risk assessment involving the Medical Physics Expert
 2   (MPE) and the practitioner, the suspended equipment may be considered for use in
 3   limited circumstances. The holder and the operators must be advised in writing of the
 4   suspension and/or the related limitation(s) in use. 2

 5   A suspension level not being met requires that the equipment is taken out of service
 6   immediately. Not meeting the level makes the equipment unsafe, or performance so
 7   poor, that it would be unacceptable to society.                                 The level is based on minimum
 8   standards of safety and performance that would be acceptable in the EU and
 9   represent the expert judgement of the working group and reviewers based on their
10   knowledge of what is acceptable among their peers and informed by the social, legal
11   and political circumstances that prevail in the EU. When suspension levels are
12   reached the equipment must be removed from use (or restricted in use) with patients,
13   either indefinitely or until it is repaired and again satisfies the criteria.

14   It is also possible that the equipment will pass an evaluation based on suspension
15   levels but be unsatisfactory in some other way. This may be because we have
16   mainly considered suspension levels as performance tolerances (particularly in
17   radiotherapy) whereas equipment may very well fail on safety issues which are
18   covered by the IEC general standards 60601-1 (IEC, 2003b) and associated
19   collateral and particular standards. Many quality assurance manuals refer to the
20   levels triggering such actions as remedial levels.                                      In line with the precedent
21   established in RP 91 (EC, 1997), the main thrust of this publication is concerned with
22   suspension levels.                 Remedial levels are, on the other hand, well described in
23   numerous quality assurance publications detailing them (AAPM, 2005; IPEM, 2005a,
24   b; AAPM, 2002; EC, 1997, IPEM, 1997a, b, c; et al).

25   Suspension levels are taken as the criteria of acceptability. They must be clearly
26   distinguished from the levels set for acceptance tests.                                       The latter are used to
27   establish that the equipment meets the supplier’s specification or to verify some other
28   contractual issue; they may be quite different from the criteria of acceptability

     2
       Examples of how this might arise include the following: 1.In radiotherapy, a megavoltage unit with poor isocentric accuracy
     could be restricted to palliative treatment until the unit could be replaced. 2. In nuclear medicine, a rotational gamma camera
     with inferior isocentric accuracy could be restricted to static examinations. 3. In diagnostic radiology, an x-ray set with the beam
     limiting device locked in the maximum field of view position might be used to expose films requiring that format in specific
     circumstances.



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 1   envisaged in the directive. However, it is entirely possible that equipment meeting
 2   the requirements of the acceptance test will automatically pass the criteria of
 3   acceptability. This is because the acceptance test for modern equipment will often
 4   be more demanding than the criterion of acceptability. Tests based on the criteria of
 5   acceptability should be performed on installation and thereafter regularly or after
 6   major maintenance.

 7   In practice, acceptability testing should assure the equipment tested is serviceable
 8   and provides acceptable clinical image quality using acceptable patient radiation
 9   doses. QA testing may involve additional elements beyond the acceptability and will
10   inevitably involve reporting many remedial levels. It is presumed that by the time
11   acceptability is considered, acceptance tests, compliance with manufacturer’s
12   specifications and commissioning tests have been successfully performed.
13   Equipment may be significantly reconfigured during its useful life arising from
14   updating, major maintenance or changes in its intended use. If this is done,
15   appropriate new acceptability tests will be required.

16           1.4.3.IDENTIFYING AND SELECTING CRITERIA


17   It was not possible to devise a single acceptable approach to proposing values or
18   levels for the criteria selected.            Instead a number of approaches, with varying
19   degrees of authority and consensus attaching to them, have been adopted and
20   grouped under headings A to D as follows:

21   Type A Criterion


22   This type of criterion is based on a formal national/international regulation or an
23   international standard.

24   A reasonable case can sometimes be made for using a manufacturer’s specification
25   as a criterion of acceptability. For example, all CE marked equipment, which meets
26   specification, will either meet or exceed the essential safety standards with which the
27   equipment complies. Thus, testing to the manufacturer’s specification could be taken
28   as a means of ensuring the criteria of acceptability are met or exceeded in the area
29   they address.



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 1   A case can also be made that compliance with the relevant IEC, CENELEC or
 2   national standards might be taken as compliance with criteria that the industry has
 3   deemed to be essential for safety. In practice, this approach may be limited in value
 4   as the tests required may not be within the competence of end users or service
 5   engineers in the field.              Thus different agreed approaches to verification will be
 6   required.              Development in this area is essential to the harmonization referred to
 7   above. In particular, agreed methodology is essential in any system of equipment
 8   testing. Standards organizations provide a useful role model in this regard, which
 9   this publication has tried to emulate.3

10   Type B Criterion


11   This type of criterion is based on formal recommendations of scientific, medical or
12   professional bodies.

13   Where industrial standards are not available or are out of date, advice is often
14   available from professional bodies, notably IPEM, AAPM, NEMA, BIR, ENMS, ACR
15   et al. More detailed advice on testing individual systems is available from the AAPM,
16   earlier IPEM publications and a wide range of material published by many
17   professional bodies and public service organizations. Much of the material is peer
18   reviewed and has been a valuable source where suitable standards are not available.

19   Type C Criterion


20   This type of criterion is based on material published in well established scientific,
21   medical or professional journals.

22   Where neither standards nor material issued by professional bodies are available,
23   the published scientific literature has been consulted and a recommendation from the
24   drafting group has been proposed and submitted to expert review by referees.
25   Where this process led to a consensus, the value has been adopted and is
26   recommended below.

     3
       When equipment standards are developed so that their recommendations can be addressed to and accepted by both
     “manufacturers and users”, the question of establishing criteria of acceptability becomes much simplified. Highly developed
     initiatives in this regard have been undertaken in radiotherapy (see IEC 60976 and IEC 60977). These “provide guidance to
     manufacturers on the needs of radiotherapists in respect of the performance of MEDICAL ELECTRON ACCELERATORS and
     they provide guidance to USERS wishing to check the manufacturer’s declared performance characteristics, to carry out
     (footnote continued)


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 1   Type D Criterion


 2   The Type D situation arises where it has not been possible to make a
 3   recommendation.             In a small residue of areas it has not been possible to make
 4   recommendations for a variety of reasons.                           For example, where the technology
 5   involved is evolving rapidly, listing a value could be counterproductive.                                      It could
 6   become out of date very rapidly or it could act as an inhibitor of development. In
 7   such situations we feel the criterion of acceptability should be determined by the
 8   institution holding the equipment based on the advice of the MPE or Radiation
 9   Protection Adviser (RPA) as appropriate.

10   The criteria of acceptability proposed are identified as belonging to one or another of
11   these categories. In addition, at least one reference to the primary source for the
12   value and the method recommended is provided. Some expansion on the approach
13   and the rationale for the choice is provided, where deemed necessary in an
14   Appendix. Test methods are only fully described if they cannot be referred to in a
15   high quality accessible reference.

16
17       1.5. SPECIAL CONSIDERATIONS, EXCEPTIONS AND EXCLUSIONS


18            1.5.1.SPECIAL CONSIDERATIONS


19   The directive requires that special consideration be given to equipment in the
20   following categories:

21       •    Equipment for screening,

22       •    Equipment for paediatrics and

23       •    High dose equipment, such as that used for CT, interventional radiology, or
24            radiotherapy.




     acceptance tests and to check periodically the performance throughout the life of the equipment”. This approach has much to
     offer other areas.



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 1   The chapters and sections in the attached volumes dealing with the high dose group
 2   (CT, interventional radiology or radiotherapy), deal comprehensively with this
 3   requirement.

 4   Equipment used for paediatrics and in screening programmes is often similar or
 5   possibly identical to general purpose equipment. Where this is the case, additional
 6   guidance for the special problems of paediatrics, such as the requirement for a
 7   removable grid in general radiology or fluoroscopy and the special needs with regard
 8   to CT exposure programmes are noted in the technology specific sections. The
 9   special requirements for mammography are based on those appropriate to screening
10   programmes.

11           1.5.2.EXCEPTIONS


12   Exceptions to the recommended criteria may arise in various circumstances. These
13   include the cases cited in Section 1.2 above, where equipment compliant with safety
14   and performance standards that predate the criteria for acceptability has to be
15   assessed. In such cases, the MPE should make a recommendation to the end user
16   or holder, on whether or not this level of compliance is sufficient to meet the
17   intentions of the directive. These recommendations must take a balanced view of the
18   overall situation, including the economic/social circumstances, older technology etc.;
19   they may be nuanced in that the RPA/MPE may recommend that the equipment be
20   accepted subject to restrictions on its use. Likewise it is always well to remember
21   that acceptability criteria, as already outlined, may depend on the use(s) for which
22   equipment is deployed.

23           1.5.3.RAPIDLY EVOLVING TECHNOLOGIES


24   Medical imaging is an area in which many new developments are occurring.
25   Encouragement of development in such an environment is not well served by the
26   imposition of rigid criteria of acceptability.            Such criteria, when rigorously enforced,
27   could become obstacles to development and thereby undermine the functionality and
28   safety they were designed to protect.                  In such circumstances, the MPE should
29   recommend to the end-user a set of criteria that are framed to be effective with the
30   new technology and that takes account of related longer established technologies,


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 1   any IEC/CEN/CENELEC standards available, the manufacturer’s recommendations,
 2   the related scientific and professional opinion/published literature and the maxim that
 3   the new technology should aspire to be at least as safe as existing technology it is
 4   replacing.

 5           1.5.4.EXCLUSIONS


 6   Within this publication, the term “equipment” has been interpreted to mean the main
 7   types of equipment used in diagnostic radiology, nuclear medicine and radiotherapy.
 8   This follows the precedent established in RP 91 (EC, 1997). It is important to be
 9   aware that the full installation is not treated.                    Thus, the requirements for an
10   acceptable physical building and shielding that will adequately protect staff, the public
11   and, on occasions, patients; power supplies and ventilation have not been
12   addressed.       However, this is an area of growing concern and one in which the
13   requirements have changed considerably as both equipment and legislation have
14   changed. In addition the acceptable solutions to the new problems, arising from both
15   equipment development and legislation, in different parts of the world, are different.
16   Consequently, this area is now in need of focused attention in its own right.

17   Likewise, the contribution of IT networks to improving or compromising equipment
18   functionality can bear on both justification and optimization. This can apply to either
19   PACS or RIS networks in diagnostic radiology and imaging, planning and treatment
20   networks in radiotherapy centres. The requirements for acceptability of such
21   networks are generally beyond the scope of this publication, although they have been
22   included occasionally, for example in radiotherapy, where they are integral to the
23   treatment.

24   As already mentioned elsewhere, the publication focuses on criteria of acceptability
25   and it does not offer advice intended for use in routine Quality Assurance
26   programmes.

27
28       1.6. ESTABLISHING CRITERIA OF ACCEPTABILITY HAVE BEEN MET


29   The criteria of acceptability will be applied by the competent authorities in each
30   member state. The authorities for the MED are generally not the same as those for

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 1   the MDD. In addition the criteria will be introduced and applied in the context of the
 2   unfolding requirements for clinical audit in healthcare in general and in the
 3   radiological world in particular. This is accompanied by a general increase in the
 4   requirements for individual and institutional accreditation. Thus the holder of
 5   radiological equipment should appoint a competent person to establish that the
 6   criteria of acceptability have been met. The person appointed should be an MPE or
 7   a person of similar standing. Who performs the tests to verify compliance is a matter
 8   for local arrangements. Thus the MPE may choose to perform the tests themselves,
 9   write them up, report on them and sign them off. Alternatively, he/she may accept
10   results provided by the manufacturer’s team. These may have been acquired, for
11   example, during acceptance testing or commissioning. Results for tests performed to
12   agreed methodology will be satisfactory in many cases. They provide the information
13   on which the MPE can make a judgement on whether or not the equipment meets
14   the criteria. These two approaches represent the extremes. Most institutions will
15   establish a local practice somewhere between that allows the criteria to be verified
16   with confidence by a suitably qualified agent acting on behalf of the end user. In
17   radiotherapy, joint acceptance testing by the manufacturer’s team and the holder’s
18   MPE is commonplace. Whichever approach is taken, where a suspension level is
19   not met, the outcome and any associated recommendations from the MPE and/or the
20   practitioner must be communicated promptly, in writing, to both the holder and the
21   operators/users of the equipment.

22   In situations where the formally recommended criteria of acceptability are incomplete,
23   lack precision, or where the equipment is very old, subject to exception, special
24   arrangements or exemptions, the judgement and advice of the MPE becomes even
25   more important.          Additional, more complete, measurements may be needed to
26   determine the cause of the change in performance. When equipment fails to meet
27   the criteria, agreement must be established on how it will be withdrawn from use with
28   patients. This must be done in association with the MPE whose advice must be
29   obtained. The options, in practice, include those mentioned above and include the
30   possibility of immediate withdrawal, where the failure of compliance is serious
31   enough to warrant it. Alternatively a phased withdrawal or limitations on the range of
32   use of the equipment may be considered.                           In the latter case, the specific
33   circumstances under which the equipment may continue to be used must be carefully

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1   defined and documented. In addition, the advice of the MPE to the practitioner and/or
2   the holder or the holder’s representative must be made available in a prompt and
3   timely way, consistent with the recommendations for action.




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 1                                       2. DIAGNOSTIC RADIOLOGY


 2   The technical parts of Sections 2, 3, and 4 assume those reading and using them are
 3   familiar with the introduction and have a good working knowledge of the relevant types of
 4   equipment and appropriate testing regimes.

 5       2.1. INTRODUCTION


 6   Since RP 91 (EC, 1997), there have been a number of major developments in diagnostic
 7   radiology. Perhaps the key new developments are the introduction of direct digital detectors
 8   (e.g. large area flat panel detectors) for use in radiology and fluoroscopy, as well as multiple
 9   slice computed tomography scanners. Both these new developments have implications for
10   acceptability criteria, but suspension levels in these areas are less mature.

11   Manufacturers have also incorporated information technology and other developments into
12   medical imaging systems which have resulted in radiological imaging equipment being
13   more stable. For instance, the stability of the applied tube potential produced by high
14   frequency generators has been much improved when compared with previous x-ray
15   generator designs (e.g. single phase). As equipment performance evolves, so do
16   acceptability criteria.

17   With the implementation of the quality culture within radiology departments and the
18   evolution of quality assurance programmes, criteria have also changed. In part the
19   availability of instrumentation for determination of radiation exposure in radiology linked to
20   computers has also impacted on measurement approaches and quality assurance.

21   However, in rapidly evolving areas of radiology, such as CT scanning, acceptability criteria
22   have not kept pace with technological developments. There is a deficit in consensus based
23   acceptability criteria for these areas of practice which will need to be addressed in the
24   future. Acceptability criteria for all types of diagnostic radiology equipment are summarised
25   in the following sections.




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 1       2.2. X-RAY GENERATORS AND EQUIPMENT FOR GENERAL RADIOGRAPHY


 2           2.2.1.INTRODUCTION


 3   General radiographic systems still provide the great majority of X-Ray examinations. They
 4   may be subdivided in practice into a number of subsidiary specialist types of system. This
 5   section deals with the Suspension Levels applicable to X-Ray generators, and general
 6   radiographic equipment. It also includes or is applicable to mobile systems, traditional
 7   conventional tomography and tomosynthesis systems, system subcomponents/devices
 8   such as automatic exposure control (AEC), and grids. Much of what is presented here is
 9   also applicable to generators for fluoroscopic equipment. However, the criteria have not
10   been developed with specialized X-ray equipment in mind: dental, mammographic, CT and
11   DXA units are mentioned in sections 2.4, 2.5, 2.7, and 2.8.

12   The criteria here refer to X-ray tube and generator, output, filtration and half value layer
13   (HVL), beam alignment, collimation, the grid, AEC, leakage radiation and dosimetry.
14   Suspension/tolerance levels are specified in the Tables below. Before presenting them a
15   few aspects of half value layer and filtration, image quality, paediatric concerns, AEC,
16   mobile devices, and spatial resolution must be mentioned to ensure that the approach and
17   the Tables are interpreted correctly.
18
19   HVL/filtration

20   Total filtration in general radiography should not normally be less than 2.5 mm Al. The half
21   value layer (HVL) is an important metric used as a surrogate measurement for filtration. It
22   shall not be less than the values given in Table 2.1.




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 1   Table 2.1 Minimum half-value layer (HVL) requirements
       Application            Values     of    x-ray    tube Minimum           permissible       (HVL)   in   mm   Al
                              voltage. (kV)                     (IEC 60601-1-3 (IEC, 2008a) and see Notes 1
                                                                and 2)
       General                <50                               See note 3
       radiography        x- 50                                 1.8
       ray equipment          60                                2.2
                              70                                2.5
                              80                                2.9
                              90                                3.2
                              100                               3.6
                              110                               3.9
                              120                               4.3
                              >120                              see note 3
 2   Note 1: These HVLs correspond to a total filtration of 2.5 mm Al for equipment operating at constant potential
 3   in tungsten anode.
 4   Note 2: Linear extrapolation to be used here.
 5   Note 3: Test methods differ for different modalities.


 6
 7   Paediatric Issues

 8   Requirements for radiography of paediatric patients differ from those of adults, partly related
 9   to differences in size and immobilization during examination (see notes in Tables
10   throughout Section 2).            Beam alignment and collimation are particularly important in
11   paediatric radiology, where the whole body, individual organs and their separation distance
12   are smaller.       The x-ray generator and tube must have sufficient power to make short
13   exposure times possible. In addition the option to remove the grid from a radiography
14   table/image receptor is essential in a system for paediatric use, as is the capacity to disable
15   the AEC and use manual factors. Systems used with manual exposures (like dedicated
16   mobile units for bedside examinations) should have exposure charts for paediatric patients.
17
18   Image Quality and Spatial Resolution

19   There are unresolved difficulties in determining objective measures of image quality that are
20   both reproducible and reflect clinical performance. Measurements here are limited to high



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 1   contrast bar patterns, and may be augmented by subjective or semi subjective
 2   assessments at the discretion of the MPE and the Practitioner. (Appendix 1)

 3

 4   Automatic exposure control for any radiographic detector

 5   The AEC should provide limitation of under- and overexposure of the receptor and
 6   exposure time. Digital generators also require that pre-programmed exposure systems be
 7   assessed to ensure acceptability based on the suppliers’ specification and the MPE’s
 8   evaluation. It may also, at the discretion of the MPE, and subject to its being an agreed part
 9   of the equipment specification with the supplier, include assessment of Ka,e for a specific
10   type of examination (see Table 2.2 below for radiographic detectors (method in Appendix
11   2). This should be such that the Ka,e for the patient phantom is below an agreed diagnostic
12   reference level (DRL). In addition, the optical density of the film should be between 1.0 and
13   1.5 OD (SBHP-BVZF, 2008).

14   Table 2.2 Examples of image receptor Ka,e for various examinations for some specific
15   conditions see note 1
      Examination                             Image receptor entrance air PMMA                              Tube
                                              kerma (incl. back scatter)  thickness (cm)                    voltage
                                              Ka,e (µGy)                                                    (kVp)
      Abdomen radiograph adult)               5                           20                                80
      Chest radiograph (adult)                5                           11                                120
      Chest radiograph (child)                5                           8                                 80
16
17   Note 1: For method see Appendix 2; this also includes some information on CR and DDR.
18
19
20   Mobile devices

21   For mobile devices the criteria for equipment for general radiography are applicable except
22   the requirements for alignment, which cannot be met in practice.
23
24   Conventional tomography

25   The parameters for conventional tomography equipment include cut height level, cut plane
26   incrementation, exposure angle, cut height uniformity and spatial resolution.




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1           2.2.2.CRITERIA FOR X-RAY GENERATORS, AND GENERAL RADIOGRAPHY


2   Table 2.3: Criteria for Acceptability of General Radiography Systems
     Physical Parameter              Suspension Level               Reference         Type       Notes (Paediatrics)
    Mechanical and                If defects pose an              IEC 60601            A       Mechanical and
    electrical safety             immediate mechanical            Series                       electrical safety
                                  or obvious electrical                                        failures can be the
                                  hazard to patients or                                        source of accidents
                                  staff
    X-RAY SYSTEM
    x-ray tube and
    generator
    tube voltage accuracy                                                               A      Lower kVp often used
                                                                                               in paediatrics (EC,
                                                                                               1996c)
    Dial calibration              Maximum deviation: >            EC (1997)             A
                                  ± 10% or ± 10 kV                IPEM                  B
                                                                  (2005a)
    Variation with tube           Maximum variation: >            EC (1997)             B
    current                       ± 10%
    Precision of tube             Deviation > ± 5% from           EC (1997)             A
    voltage                       mean
    x-ray tube output
    Magnitude of output           Y(1m) > 25 µGy/mAs at           EC (1997)             A
                                  80 kV and 2.5 mm Al
    Consistency of output         Y within ± 20% of mean          EC (1997 )            B
                                                                  IPEM
                                                                  (2005a)
    Consistency of output         Y within ± 20% of mean          IPEM                  B
    for range of qualities                                        (2005a)
    Half-value layer (HVL
    ) /total filtration
    HVL or sufficient total       HVL in excess for               IEC (2008)            A      Additional Cu filtration
    filtration                    values in Table 8.1                                          0.1 or 0.2 mm (EC,
                                                                                               1996c) (A)
    Exposure time
    Consistency of                Actual exposure time >          EC (1997)             A      Consistency and
    exposure time                 ± 20% of indicated              IPEM                  B      absolute values
                                  value for values >              (2005a)                      required for shorter
                                  100ms                                                        exposures, particularly
                                                                                               in paediatrics (EC,
                                                                                               1996c)
    Alignment
    x-ray/light beam              Sum of misalignment in          IPEM                  B
    alignment                     principle directions >          (2005a)
                                  3% of dFID

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Orthogonality of x-ray        The angle between               EC (1997)             A
beam and image                central beam axis and
receptor (IR)                 IR ≤ 1.5º from 90º
Collimation
Collimation of x-ray          x-ray beam within               EC (1997)             A
beam                          borders of image
                              receptor
Automatic collimation         X-ray beam shall not            EC (1997)             A
                              differ by more than 2%
                              of dFID at any side of
                              image receptor
                              Borders within IR
Grid                                                                                A      Grids preferably not to
                                                                                           be used with children
                                                                                           (EC, 1996c)
Grid artefacts                No artefacts should be          EC (1997)             A
                              visible
Moving grid                   Lamellae should not be          EC (1997)             A
                              visible on image
AEC verification                                                                           See also Appendix 2
Focal spot (FS) size                                                                A      Smaller sizes may be
through assessment of                                                                      required for various
spatial resolution                                                                         applications including
                                                                                           paediatrics (EC,
                                                                                           1996c)
Spatial resolution            Spatial resolution ≥ 1.6        JORF                  B      DIN standard
(limited by FS size and       lp/mm                           (2007a)
detector
characteristics)
Limitation of                 Maximal focal spot              EC (1997)             A      Much equipment is
overexposure                  charge < 600 mAs                                             non compliant in
                                                                                           practice.Should this be
                                                                                           modified.
Limitation of exposure        Maximum exposure                EC (1997)             A
time                          time: 6s
Consistency of AEC            Ka may not differ by            SBPH-BVZ              B      See also Appendix 2
unit                          more than 10% from              (2008)
                              mean value
Verification of Ka,e at       See table 2.2.                  SBPH-BVZ              B      See also Appendix 2
image receptor for             1.0 < OD >1.5                  (2008)
reference examination
Verification of sensors       Film density for each           SBPH-BVZ              B      For chest
of AEC                        sensor may not differ           (2008)                       examinations sensors
                              by more than 0.2 OD                                          are different on
                              from mean value                                              purpose.
                                                                                           See also Appendix 2
Verification of AEC at        Film density for a              SBPH-BVZ              B      See also Appendix 2
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    various phantom               phantom thickness               (2008)
    thicknesses                   differs by more than 0.3
                                  OD from mean value
                                  for all thicknesses
    Verification of AEC at        Film density at a tube          SBPH-BVZ              B      See also Appendix 2
    various tube voltages         voltage may not differ          (2008)
                                  by more than 0.2 OD
                                  from mean value for all
                                  tube voltages
    Dose to plate in CR           ≥ 10 µGy/plate                  Walsh et al           C      NOTE: This is double
    and DDR Systems                                               (2008.)                      the max normally
    under AEC                                                                                  encountered (3-5
                                                                                               uGy/plate). Grid in
                                                                                               position for this
                                                                                               measurement.
    AEC performance in            > 50%*                          Walsh et al           C      * >50% variation
    CR and DDR Systems:                                           (2008)                       allowed for 5 cm
                                                                                               PMMA.
    Leakage radiation
    Leakage radiation             Ka(1m) < 1mGy in one            EC (1997)             A
                                  hour at maximum rating
    Dosimetry
    For KAP meters see
    2.6
    Image quality                 Spatial better than 2.8         DIN 6868-58           B      Use phantom
                                  lp/mm for dose < 10             (2001)                       described in the
                                  µGy.                                                         standard
                                  And better than 2.4
                                  lp/mm for dose < 5
                                  µGy.
    Contrast                      All seven steps are not         DIN 6868-58           B      Use phantom
                                  visible                         (2001)                       described in the
                                                                                               standard

1


2




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 1   Table 2.4: Criteria for Acceptability of Conventional Tomography Systems


       Physical Parameter                            Suspension Level                          Reference       Type


     Cut height level                 Difference between indicated and measured               EC (1997)          A
                                      value < 5 mm


     Cut plane incrementation         Reproducibility cut height < 2 mm                       EC (1997)          A


     Exposure angle                   Indicated and measured angle should agree               EC (1997)          A
                                      within 5° for angles more than 30°.
                                      Agreement better for smaller angles


     Cut height uniformity            Image should reveal no overlaps,                        EC (1997)          A
                                      inconsistencies of exposures, or
                                      asymmetries in motion


     Spatial resolution               Resolution < 1.6 lp/mm                                  EC (1997)          A

 2

 3       2.3. RADIOGRAPHIC IMAGE RECEPTORS AND VIEWING FACILITIES


 4           2.3.1.INTRODUCTION


 5   The Criteria of Acceptability and the related suspension/tolerance levels for X-Ray Films,
 6   Screens, Cassettes, CR, DR, Automatic Film Processors, the Dark Room, Light Boxes and
 7   the Environment for general radiography are presented in Tables 2.5 to 2.12 below. They
 8   do not deal with the requirements for mammography or dental radiography.

 9   A wider approach to Quality Assurance of film, film processing and image receptors of all
10   types is a critical part of an overall day to day quality system (IPEM, 2005a; BIR, 2001,
11   IPEM, 1997a; Papp, 1998).                    Such a system includes commissioning.                       Detailed
12   commissioning tests are covered in other publications (IPEM, 1997a).

13   There are some fundamental differences between CR and film/screen systems. Proper
14   installation and calibration of a CR system in a radiology department is extremely important.
15   It is also important to note that the x-ray system needs to be properly set up so that it may



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 1   be used with CR plates. In particular, the AEC needs to be appropriately set up (Section
 2   2.2).

 3   Details on desirable specifications and features of CR systems as well as their proper
 4   installation can be found in AAPM Report No 93 (2006a). These guidelines should be
 5   followed prior to the acceptability testing of CR systems. To date, unlike film systems, there
 6   is little guidance on the performance of CR systems, and the suspension/tolerance levels
 7   identified will almost inevitably need adjustment in line with future evidence and guidance
 8   (Section 1.4).

 9   Likewise, with DDR systems, the tube and generator, workstation and /or laser printer must
10   be known to be working properly. When undertaking the QA of the tube and generator, it is
11   advisable to keep the detector out of the beam or protected by lead. As with CR little
12   guidance is available on Suspension/Tolerance levels and the advice given above for CR
13   prevails.     Suspension/ tolerance levels suitable for application at the present time are
14   provided in Table 2.7.

15   Display monitors and hardcopy images have a crucial role in the diagnostic process. IPEM
16   notes that inadequacies in the imaging viewing area may serve to negate the benefits of
17   other efforts made to maintain quality and consistency. Modern radiology departments
18   require digital images from many modalities and from PACS systems to be viewed in many
19   locations. Two classes of display are used: diagnostic (systems used for the interpretation
20   of medical images) and review (viewing medical images for purposes other than for
21   providing a medical interpretation). The requirements for each are different.




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1            2.3.2.CRITERIA FOR IMAGE RECEPTORS AND VIEWING FACILITIES


2    Table 2.5 Criteria of Acceptability for Automatic Film Processors, Films, Screens, Darkrooms
3    and Illuminators (mammography excluded)
    Physical Parameter            Suspension                     Reference                Type             Notes
                                    Level
    Automatic Film
    Processor:
    Base plus Fog             OD > 0.3                 IPEM (2005a)                         B       See also IEC 61223-
                                                       IPEM (1997a)                                 2-1 (1993c), Papp
                                                                                                    (1988) and EC
                                                                                                    (1997)
    Speed Index               1.2 ± 0.3                IPEM (2005a)                         B       See also IEC 61223-
                                                       BIR (2001)                                   2-1 (1993c) and
                                                       IPEM (1997a)                                 Papp (1988).
    Contrast Index            1.0 ± 0.3                IPEM (2005a)                         B       See also IEC 61223-
                                                       BIR (2001)                                   2-1 (1993c) and
                                                       IPEM (1997a)                                 Papp (1988).
    Films, Screens,
    Darkroom and
    Illuminators:
    Screens and               Visible artefacts.       IPEM (2005a)                         B       See also IEC 61223-
    Cassettes                                          BIR (2001)                                   2-2 (1993d) and EC
                                                       IPEM (1997a)                                 (1997).
    Relative Speed of         > 10% or                 IPEM (2005a)                         B       See also EC (1997).
    Intensifying Screens      > 0.3 OD across          IPEM (1997a)
                              film.
    Film Screen Contact       Non-uniform              IPEM (1997a)                         B       See also IEC 61223-
                              density or loss of                                                    2-2 (1993d) and EC
                              sharpness.                                                            (1997).
    Dark Room Safe            Evidence of film         IPEM (2005a)                         B       See also IEC 61223-
    Lights and Film           fogging after twice      BIR (2001)                                   2-3 (1993e).
    fogging                   the normal Film          AAPM (2002)
                              Handling Time.
    Ambient Lighting          > 100 Lux.               IPEM (1997a)                         B       See also Papp
                                                                                                    (1988), EC (1997).
4

5


6


7


8

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1   Table 2.6 Criteria for Acceptability of Cassettes and Image Plates:
     Physical Parameter          Suspension Level               Reference           Type          Notes
     Condition of               Damage to plate               IPEM (2005a)           B   Suppliers’
     cassettes and image                                                                 recommendations for
     plates                                                                              method
     Uniformity                 Gross non-uniformity          IPEM (2005a)           B   70kV, 1.0 mm copper
                                Mean ± 20%                                               at tube head, an
                                                                                         exposure for 10µGy,
                                                                                         read plate under linear
                                                                                         algorithm.

2   Table 2.7 Criteria for Acceptability of CR readers see notes 1 and 2
    Physical Parameter            Suspension Level               Reference           Type                Notes
    Dark Noise                   Agfa SAL>130                  AAPM (2006a)           B       Erase plates, leave
                                 Fuji pixel value > 280                                       plates 5 minutes, read
                                 Kodak EIGP > 80                                              under standard
                                 Kodak EIHR > 380                                             conditions.
                                 Konica pixel value <                                         Repeat for all plate
                                 3975                                                         sizes.
    Linearity and system         Manufacturer’s                KCARE (2005a)           B      KCARE CR QA.
    transfer properties          specification                                                Establish system
                                                                                              transfer properties
                                                                                              equation (STP)
                                                                                              Dose=f(pixel value)
    Erasure cycle                Blocker visible in            IPEM (2005a)            B      High attenuation
    efficiency                   second image                                                 material
    Exposure index               Indicated exposure            KCARE (2005a)           B      Record detector dose
    consistency                  does not agree with                                          indicator and calculate
                                 measured exposure                                            indicated exposure
                                 within 20%                                                   using the STP equation
                                                                                              for all plates
    Detector dose                The variation in the          KCARE (2005a)           B
    indicator consistency        calculated indicated
                                 exposures differs by
                                 greater than 20%
                                 between plates for a
                                 same exposure
    Scaling errors               > 2%                          IPEM (2005a)            B
    Blurring                     Blurring present              KCARE (2005a)           B      Use contact mesh
    Image quality High           Spatial resolution            DIN 6868-58            A,C     Use phantom described
    Contrast Resolution          better than 2.8 lp/mm         (2001)                         in the standard. Also
    (Limiting Spatial            for dose < 10 µGy.                                           note AAPM, 2006a &
    Resolution)                  ≥ 2.4 lp/mm for dose <                                       Walsh et al. 2008
                                 5 µGy.
    Contrast                     All seven steps visible       DIN 6868-58            A,C     Use phantom described
                                                               (2001)                         in the standard

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    Low-Contrast                 Manufacturers                 AAPM (2006a)            B      Low contrast resolution
    Resolution                   specifications                                               test object
    Laser beam function          Edge not continuous           AAPM (2006a)            B      Steel ruler
                                 the full length of the
                                 image
    Moiré Patterns               Moiré Patterns visible        KCARE (2005a)           B      70kV, 1.0mm of copper
                                                                                              at tube head, grid in
                                                                                              place, plate in the
                                                                                              bucky at 150cm from
                                                                                              the focus
1
2
3       1. The suspension values quoted for Dark Noise were valid at the time of Publication of this document.
4          However as CR is an evolving technology they are subject to change.
5       2. This is a test that has to be done during the acceptance testing of the CR Reader in order to establish
6          the relationship between receptor dose and pixel value. It tests whether the X-ray generator and the
7          CR reader have been properly set up in order to work together correctly.
8




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1   Table 2.8 Criteria of Acceptability for DDR systems see notes 1, 2
         Physical               Suspension Level                 Reference             Type              Notes
        Parameter
    Dark Noise               Excessive noise in the         IPEM (2005a )                B      Image without
                             system                                                             exposure or very low
                                                                                                exposure
    Linearity                Manufacturers                  KCARE (2005b)                C      Establish system
                             recommendation                                                     transfer properties
                                                                                                equation (STP)
                                                                                                Dose=f(pixel value)
    Image retention          Ghosting present               KCARE (2005b)                C      Low exposure with
                                                                                                closed collimators and
                                                                                                detector covered with
                                                                                                lead apron.
    Exposure Index           Indicated sensitivity          KCARE (2005b)                C      70kV, 1.0 mm copper
                             indices differ by greater                                          at tube head, at least
                             than 20% of equivalent                                             three times for 10
                             exposure sets.                                                     µGy. Repeat for 1
                                                                                                µGy and 12 µGy

    Uniformity               Mean ± 5%                      IPEM (2005a)                 B      70kV, 1.0 mm copper
                                                                                                at tube head, 10 µGy.
    Scaling errors           >2%                            IPEM (2005a)                 B      Grid, attenuating
                                                                                                object of known
                                                                                                dimensions or lead
                                                                                                ruler
    Uniformity of            Blurring present               IPEM (2005a)                 B      Use fine wire mesh
    resolution
    Image quality High       Spatial resolution better      DIN 6868-58                 A,C     Use phantom
    Contrast                 than 2.8 lp/mm for dose        (2001)                              described in the
    Resolution               < 10 µGy.                                                          standard. Also note
    (Limiting Spatial        ≥ 2.4 lp/mm for dose <                                             AAPM (2006a) &
    Resolution)              5 µGy.                                                             Walsh et al. (2008)
    Contrast                 All seven steps are            DIN 6868-58                 A,C     Use phantom
                             visible                        (2001)                              described in the
                                                                                                standard
2

3       1. This test should be done at the acceptance testing of the DDR system in order to establish the
4          relationship between receptor dose and pixel value. This is the relationship between the generator
5          and the detector.

6       2. It should be noted that a number of manufacturers have installed on their DDR equipment automatic
7          QA software in order to carry out a number of QA tests.

8

9

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1   Table 2.9 Criteria of Acceptability for Diagnostic Monitors

         Physical Parameter                     Suspension Level                     Reference                 Type
    luminance ratio                           <200                            IPEM (2005a)                      B
                                                                              AAPM (2006a)
    luminance ratio                           Black baseline ±35%             IPEM (2005a)                       B
                                              White baseline ±30%             AAPM (2006a)

    Distance and angle calibration –          10%                             IPEM (2005a)                       B
    distortion (for CRT)                                                      RCR (2002)
                                                                              SEFM-SEPR (2002)
    Resolution                                Visual inspection low           IPEM (2005a)                       B
                                              and high contrast               AAPM (2006a)
                                              resolution different from
                                              baseline
    DICOM greyscale                           GSDF ±15%                       IPEM (2005a)                       B
    (GSDF= DICOM Grayscale                                                    AAPM (2006a)
    Standard Display Function)
    Uniformity                                >40%                            IPEM (2005a)                       B
                                                                              AAPM (2006a)
    Variation between adjacent                >40%                            IPEM (2005a)                       B
    monitors                                                                  AAPM (2006a)
                                                                              RCR (2002)
    Room illumination                         >25 lux                         IPEM (2005a)                       B
                                                                              AAPM (2006a)




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1   Table 2.10 Criteria of Acceptability for Printers
      Physical Parameter            Suspension Level              Reference             Type             Notes
    Optical density                 Baseline ±0.30            IPEM (2005a)               B        Note also AAPM
    consistency                                               BIR (2001)                          (2006a)
                                                              IEC (1994a)
    Image uniformity                >10%                      IPEM (2005a)                 B      Note also AAPM
                                                                                                  (2006a)
2

3


4   Table 2.11 Criteria of Acceptability for Film Scanners
      Physical Parameter              Suspension Level                           Reference                   Type
      Grayscale                    >10%                               Halpern (1995)                          C
                                                                      Lim (1996)
                                                                      Meeder et al (1995)
                                                                      Seibert (1999)
                                                                      Trueblood (1993)
                                                                      SEFM-SEPR (2002)
      Image uniformity             >10%                               Halpern (1995)                           C
                                                                      Lim (1996)
                                                                      Meeder et al (1995)
                                                                      Seibert (1999)
                                                                      Trueblood (1993)
                                                                      SEFM-SEPR (2002)
      Distortion                   >10%                               Halpern (1995)                           C
                                                                      Lim (1996)
                                                                      Meeder et al (1995)
                                                                      Seibert (1999)
                                                                      Trueblood (1993)
                                                                      SEFM-SEPR (2002)
      Spatial resolution           Visual inspection low and          Halpern (1995)                           C
                                   high contrast spatial              Lim (1996)
                                   resolution different from          Meeder et al (1995)
                                   baseline                           Seibert (1999)
                                                                      SEFM-SEPR (2002)
5

6

7


8


9
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 1   Table 2.12 Criteria of Acceptability for Viewing Boxes
          Physical Parameter                     Suspension Level              Reference         Type       Notes
      Luminance                                < 1000 cd/m2                  IPEM (2005a)         B       IEC (1993f)
                                               Mammography
                                               < 3,000 cd/m2
                                               > 6,000 cd/m2
       Uniformity                              >30%                          IPEM (2005a)           B     IEC (1993f)
                                               Mammography < 30%
      Variation between adjacent               >30%                          IPEM (2005a)           B     IEC (1993f)
      viewing boxes                            Mammography < 15%
      Room illumination (general               >150 lux                      IPEM (2005a)           B     IEC (1993f)
      radiography)
      Room illumination                        >50 lux                       CEC (2006)             A     IEC (1993f)
      (mammography)
 2

 3       2.4. MAMMOGRAPHY


 4           2.4.1.INTRODUCTION


 5   Mammography involves the radiological examination of the breast using x-rays. Mammography is
 6   primarily used for the detection of breast cancer at an early stage and is widely used in screening
 7   programmes involving healthy populations. It is also used with symptomatic patients. Early
 8   detection of breast cancer in a healthy population places particular demands on the radiological
 9   equipment as high quality images are required at a low dose. Perhaps because of the exacting
10   demands of mammography, acceptability criteria are particularly well developed (IPEM, 2005b;
11   CEC, 2006).

12   Mammography should be performed on equipment designed and dedicated specifically for imaging
13   breast tissue. Either film/screen or digital detectors may be used. The minimum features of a
14   mammography unit are described in table 2.13. Table 2.14 summarises the acceptability criteria for
15   conventional mammography equipment and 2.15 those for digital units.


16


17


18


19


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1   Table 2.13 Minimum Specification of an X-ray Unit Designed for mammography
                              Aspect                                                 Specification
                                                                  Broad focus 0.3           (IEC, 2003a)
      X-ray Tube Nominal Focal Spot
                                                                  Small focus 0.15
                                                                  Adjustable or automatically adjusted position
      AEC (Analogue Equipment)
                                                                  Fine control of optical density
                                                                  Motorized
      Compression
                                                                  Readout of compression thickness
      Grid                                                        Moving (dedicated mammography)
      Focus Film Distance                                         ≥ 60cm
2

3            2.4.2.MEASUREMENTS


4   Measurements to assess the performance of mammography units should be performed using a
5   series of test equipment, some of which are specifically designed for the purpose.

6   Specific Tests are outlined in the tables below. The purpose of the test and a recommended
7   protocol are cited, together with alternative acceptable protocols. These should form part of a
8   quality system (BSI, 1994).


9




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1   Table 2.14 Film Screen Mammography

    Physical Parameter                Suspension Level                  Reference            Type           Notes
                                                                                                        Not correctable
    Target Film Density         OD<1.3 or >2.1                       IPEM (2005a)           B           by AEC fine
                                                                                                        control
                                mAs > ±5% Variation in mAs
    AEC Consistency                                                  CEC (2006)             A
                                <
                                Maximum deviation in OD ≥
                                                                     CEC (2006)
    AEC Thickness               0.15 from value at 4cm of                                   A
                                                                     AFFSAPS
    Compensation                PMMA or range of ODs >                                      B
                                                                     (2007)
                                0.35
    Film/Screen Contact         >1 cm² poor contact                  CEC (2006)             A
    High Contrast
                                < 12lp/mm                            CEC (2006)             A
    Resolution
    Threshold Contrast          > 1.5% 5-6mm                         CEC (2006)             A

    X-ray/Film Alignment        > 5mm                                CEC (2006)             A
                                Maximum Force > 300N
                                200N not achievable by
    Compression                                                      CEC (2006)
                                adjustment of manual                                        A
                                control.
                                > 2kV difference from set
    Tube Potential                                                   IPEM (2005a)           B
                                value.
    HVL                         See Table 2.16                       CEC (2006)             A
    Compression Force
                                > 20N                                CEC (2006)             A           In 30S
    Consistency

2


3

4


5


6


7




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1   Table 2.15 Digital Mammography Systems
          Physical
                                           Suspension Level                           Reference         Type     Notes
         Parameter
    AEC Consistency          mAs>±5% baseline                                     CEC (2006)            A
                             CNR/PMMA Thickness, with the value at
                             5cm being used as reference, values at
    AEC Thickness            other thicknesses are 2.0cm >115%
                                                                                  CEC (2006)            A
    Compensation             4.5cm >103% 3.0cm >110% 5.0cm >
                             100% 4.0cm >105% 6.0cm > 95%
                             7.0cm > 90%
                             > 0.85% 5-6mm              > 2.35%
    Threshold Contrast                                                            CEC (2006)            A
                             0.5mm               > 5.45% 0.25mm
    X-ray/Film
                             >5mm                                                 CEC (2006)            A
    Alignment
                             Maximum Force                 > 300N and             IPEM (2005a)          B
    Compression
                             200N not reachable.                                  CEC (2006)            A
    Tube Potential
                             > 2kV difference from set value.                     IPEM (2005a)          B
    Accuracy
    HVL                      See Table 2.16                                       CEC (2006)            B
    Compression
                             > 20N                                                CEC (2006)            A        In 30S
    Force Consistency
2

3

4   Table 2.16 Typical HVL measurements for different tube voltage and target filter
5   combinations. (Data includes the effect on measured HVL of attenuation by a PMMA
6   compression plate*) (CEC, 2006)
                                     HVL (MM Al) for target filter combination
    kV      Mo +30 µm Mo          Mo +25 µm RH          RH +25 µm RH           W +50 µm RH          W +0.45 µm Al
    25      0.33 ± 0.2            0.40 ± .02            0.38 ± .02             0.52 ± .03           0.31 ±.03
    28      0.36 ± .02            0.42 ± .02            0.43 ± .02             0.54 ± .03           0.37 ±.03
    31      0.39 ± .02            0.44 ± .02            0.48 ± .02             0.56 ± .03           0.42 ± .03
    34                            0.47 ± .02                                   0.59 ± .03           0.47 ± .03
    37                            0.50 ± .02                                                        0.51 ± .03

7   * Some compression paddles are made of Lexan, the HVL values with this type of compression
8   plate are 0.01 mm Al lower compared with the values in the table.




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 1       2.5. DENTAL RADIOGRAPHY

 2           2.5.1.INTRODUCTION


 3   Dental radiography, though often delivering a low dose, is the most frequently conducted type of x-
 4   ray examination. This section is applicable to radiographic systems for intra oral radiography using
 5   both film and digital detectors.


 6           2.5.2.INTRA-ORAL SYSTEMS


 7   The following are not acceptable for dental imaging:


 8       -   Nominal or actual tube voltage < 60kVp for DC and 65-70Kvp for AC equipment


 9       -   Mechanical timers


10       -   Film class lower than E


11       -   Focus skin distance for intra oral equipment < 20cm.


12       -   Non-rectangular collimators


13       -   Systems without audible exposure indication.


14   Material and results of testing dental equipment are available in Gallagher et al. (2008), EC (1997),
15   IEC standards, and the criteria for dental equipment adopted by EU member states (Belsuit van het
16   FANC, 2008; IPEM, 2008; Luxembourg Annexe 7, 2008; JORF, 2007; IEC, 2000a; IPEM, 2005a;
17   Directive R-08-05, 2005; SEFM-SEPR, 2002).


18   Where exposure settings or pre-programmed exposure protocols are provided with the equipment,
19   their appropriateness should be checked as part of the confirmation that the equipment is
20   acceptable. A distinction should be made between exposure settings for adults and children.




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1             2.5.3.CRITERIA FOR DENTAL RADIOGRAPHY


2   Table 2.17 Criteria of Acceptability for Intra-Oral Dental Equipment

         Physical parameter             Suspension level           Reference (type)         Type              Notes
       Film development
       Developer temperature           <18°C and > 40°C            IPEM (2005a)            B            Use
                                                                   Luxembourg                           Thermometer
                                                                   Annexe 7 (2008)
       Dark room (or desktop           Gross fog > 0.3 OD          IPEM (2005a)            B            Densitometer
       day light processor)
       light proof
       Reproducibility of gross        Gross fog > 0.3 OD;         IPEM (2005a)            B            Densitometer;
       fog, speed and contrast
       X-ray tube and
       generator
       Tube voltage accuracy          Maximum deviation            JORF (2007)             A            kV meter,
                                       ± 10%
       Indication of exposure          Difference between          IPEM (2005a)            A, B         Dosimeter
       time                            measured exposure           EC (1997)
                                       time and baseline >
                                       50%
       Consistency of                                              EC (1997)               A            Dosimeter???
       exposure time
       Dosimetry
       Incident air kerma for          Ka > 4mGy                   JORF (2007)             A            Measurement
       upper molar tooth                                           Luxembourg                           of incident air
                                                                   Annexe 7 (2008)                      kerma at the
                                                                                                        tip of the
                                                                                                        collimator




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 1           2.5.4.PANORAMIC RADIOGRAPHY


 2   This section is applicable to radiographic systems for panoramic dental radiography.


 3   Table 2.18 Criteria for Acceptability of OPG Systems

         Physical Parameter               Suspension Level           Reference        Type               Notes
     Image quality
     Characteristics of the              Outside                                      D         Follow manufacturer’s
     panoramic image                     manufacturer’s                                         specifications and test
                                         specification                                          object
     Dosimetry
     Kerma area product of a Deviation > 35% of JORF                                  A         KAP       meter         or
     typical clinical exposure or indicated PKA value.              (2007)                      equivalent dosimeter.
     calculated      kerma       area
     product from dose width
     product or equivalent
 4

 5           2.5.5.CEPHALOMETRY


 6   This section is applicable to radiographic systems for cephalometry.
 7   In addition, cephalometric systems should:

 8       -   have X-ray beams collimated to the detector and not larger than 24cmx30cm
 9       -   have at least a distance of 150cm between focus and skin

10   Table 2.19 Criteria for Acceptability of Cephalometry Systems
              Physical parameter                   Suspension level            Reference          Type       Notes
     Dosimetry
     Kerma area product of a typical PKA > 80 mGycm2                         JORF (2007)         A        PKA meter or
     clinical exposure                                                       Luxembourg                   equivalent
                                                                             Annexe 7
                                                                             (2008)

11




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 1       2.6. FLUOROSCOPIC SYSTEMS


 2           2.6.1.INTRODUCTION


 3   Fluoroscopic systems can be highly flexible and are open to a wide range of applications.
 4   They may offer a multiplicity of modes (and sub-modes) of operation. A representative
 5   subset of the most probable intended uses of the equipment should be identified for
 6   acceptability testing. For example, the main “cardiac mode(s)” and associated sub-modes
 7   might be tested in a unit whose intended application will be in the area of cardiac imaging.
 8   If the unit is later deployed for different purposes the need for a new acceptability test will
 9   have to be considered by the practitioner and the MPE.

10   In many cases fluoroscopic systems are supplied as dedicated units suitable for cardiac,
11   vascular, gastrointestinal or other specific applications. Powerful mobile units are available
12   and are generally flexible.            In all cases the MPE will have to consider the intended
13   application of the unit and the environment in which it will be installed and used. With
14   respect to the X-Ray generator, many of the criteria of acceptability are similar to those
15   prevailing for general radiographic systems.




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1           2.6.2.CRITERIA FOR ACCEPTABILITY OF FLUOROSCOPY EQUIPMENT


2   Table 2.18 Criteria of Acceptability for Fluoroscopy and Fluorography Equipment
    Physical Parameter               Suspension Level               Reference           Type            Notes
    Mechanical – Safety          If defects pose an               IEC (2003b)           A        38 cm for fixed fluoro
                                 immediate mechanical or          CRCPD (2002)                   30 cm for mobile
                                 obvious electrical-shock                                        fluoro
                                 (hazard to patients or                                          20 cm for special
                                 staff)                                                          surgical fluoro
    Collimation Limits           Irradiated area > 1.15 ×         IEC (2000b)           A        Use radiography
                                 imaged area
    Half-value layer             Table 2.1 applies                IEC (2000b)           A        Test methods are
                                                                                                 modality specific
    Patient Air Kerma            The four rows BELOW              IPEM (2005a,          C        The four rows
    Rates, and Image             are SENTINEL VALUES              2002)                          BELOW are
    receptor input Air           offered for consideration        Martin et al                   SENTINEL VALUES
    Kerma Rates                                                   (1998)                         offered for
                                                                  Dowling et al                  consideration
                                                                  (2008)
                                                                  O’Connor et al
                                                                  (2008)
    “Patient” Entrance           > 50 mGy/min                     O’Connor et al        C        Normal mode
    Dose Rate, Fluoro                                             (2008)                         smallest field size.
    Mode: (Image                                                  Dowling et al                  20 cm water or
    Intensifier and FPD                                           (2008)                         equivalent.
    Systems.)                    > 100 mGy/min
                                                                                                 Normal mode, any
                                                                                                 field size. Maximum
                                                                                                 (lead)
    “Patient” Entrance           > 2mGy/exposure.                 O’Connor et al        C        IPEM and Martin
    Dose/exposure                                                 (2008)                         protocols. Largest
    Digital Acquisition                                           Dowling et al                  field size. 20 cm
    Mode (Image                  Cardiac Systems: >               (2008)                         water or equivalent.
    Intensifier and FPD          0.2mGy/exposure                                                 Normal from survey
    Systems.)                                                                                    is 0.03 – 0.12
                                                                                                 mGy/exposure)
    Detector Entrance            > 1 µGy/sec in                   O’Connor et al        C        2 µGy/sec quoted in
    Dose Rate, Fluoro            continuous fluoroscopy           (2008)                         IPEM but not seen in
    mode :(Image                 mode.                            Dowling et al                  practice.
    Intensifier and FPD                                           (2008)                         IPEM protocols.
    Systems).                    Cardiac Systems: >                                              Largest field size.
                                 1µGy/sec in continuous                                          Normal mode.
                                 fluoroscopy mode.
    Detector Entrance            > 5µGy/exposure.                 O’Connor et al        C        Normal from survey
    Dose/exposure                                                 (2008)                         0.06 – 0.2
    Digital Acquisition                                           Dowling et al                  µGy/exposure

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     Mode :(Image                 Cardiac Systems:                 (2008)                         IPEM protocols.
     Intensifier and FPD          >0.5µGy/exposure.                                               Largest field size.
     Systems.)
     Integrated “dose             If absolute accuracy             IEC (2000b)           A
     meter” calibration           > ±35 %
     High contrast                Spatial Resolution: < 1          IPEM (2005a)          B        Largest Field Size.
     resolution and focal-        lp/mm.
     spot                         For Cardiac Systems: <
                                  1.2 lp/mm
     Low contrast                 Threshold Contrast: >            IPEM (2005a)          B        Largest Field Size.
     detectability                4%
     Systems or modes of          Radiographic generator           See also              A
     operation controlled         output conditions.               Section 2.2
     by manually setting          As above for High
     X-ray factors                Contrast resolution and
                                  low-contrast detectability.
     Fluoroscopic Timer           Acoustic alert is not            See also              A
                                  functional or not                Section 2.2
                                  continuous until reset.
 1

 2       2.7. COMPUTED TOMOGRAPHY


 3           2.7.1.INTRODUCTION


 4   CT examinations are among the highest dose procedures encountered routinely in
 5   diagnostic radiology and account for up to 70 percent of diagnostic medical irradiation.
 6   Thus it is important both in terms of individual examinations and population effects. The
 7   design and proper functioning, and particularly the optimal use of equipment can
 8   substantially influence CT dose. This can be particularly important when pregnant patients
 9   or children are involved. CT scanners are under continual technical development resulting
10   in increasing clinical application (Nagel, 2002). In the last two decades the development of
11   helical and multidetector scanning modes allowed greatly enhanced technical abilities and
12   clinical application (Kalender, 2000).

13   CT scanners may be replaced for reasons that, in theory, include poor equipment
14   performance as demonstrated by failure to meet acceptability criteria. In practice it is also
15   likely that replacement may frequently be with a view to meeting increased demands on the
16   service, or to take advantage of new developments which enable improved diagnostics,
17   faster throughput or other clinical benefits. In practice there are few (if any) examples of CT

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 1   scanners being removed from use on the basis of their failure to meet currently accepted
 2   criteria of acceptability.           This suggests that these criteria are ineffective or that
 3   obsolescence due to rapid technological development can be an overwhelming
 4   consideration in equipment replacement. Arising from these observations it is possible that
 5   the available criteria, including those which follow, should be viewed with caution. A review
 6   of the dose parameters or dose to patients for certain key procedures, and their comparison
 7   to accepted diagnostic reference levels, is a more meaningful measure of the acceptability
 8   of the practice using the CT scanner, but this is outside of the scope of the current
 9   document.

10   CT scanners are increasingly utilised in radiotherapy in support of treatment planning
11   (Mutic, 2003; IPEM, 1999).              They are also a component of PET-CT systems and CT
12   acceptability criteria can be applied to the CT component.




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1             2.7.2.CRITERIA FOR ACCEPTABILITY OF CT SYSTEMS


2   Table 2.19 Criteria of acceptability for CT Equipment see notes 1-3

        Physical Parameter           Suspension Level               Reference           Type            Notes
                                                                                                   Accessible
                                                                                                   protocols4
                                    Dose ± 20% of                                                  should be
        CTDI, DLP /CVOL,
                                    manufacturer's               IEC (2004a)               A       consistent with
        CW, PK.L,CT
                                    specifications;                                                good practice5
                                                                                                   ESPECIALLY for
                                                                                                   paediatrics.
        Accuracy of indicated Dose ± 20%
                                                                                           A
        dose parameters       indicated dose
                              Noise ± 25 % of
        Image noise                                              IPEM (2005a)              B
                              baseline.
                                                                                                   Value
                                    ±8 HU                        CEC (2006)                        recommended in
        Uniformity                                                                         B
                                                                                                   IEC (2004a) is ±4
                                                                                                   HU
                                    CT number ± 20 HU
                                                                                                   (French
                                    (water); ± 30 HU
                                                                                                   standards are ±4
        CT number accuracy          (other material)             IPEM (2005a)              A
                                                                                                   HU nominal or
                                    compared to baseline
                                                                                                   baseline)
                                    values
                                                                                                   Any artefact
                                                                                                   likely to impact
        Artefact                                                                           D
                                                                                                   on clinical
                                                                                                   diagnosis
        Image Display and
                                                                                                   See section 2.3
        Printing
                                     + 0.5 mm for <1
                                    mm ; ±50% for 1 to
        Image slice width                                        IEC (2004a)               A
                                    2 mm; ± 1mm
                                    above 2 mm.
3          1 Protocols either programmed in lookup table or in written form.
4          2 MPE should compare procedure dose levels with appropriate DRLs
5          3 applicable for equipment manufactured after 2001

6




    4
        Protocols are programmed in lookup table or in written form
    5
        MPE should compare procedure dose levels with appropriate diagnostic reference levels

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 1       2.8. DUAL ENERGY X-RAY ABSORPTIOMETRY


 2           2.8.1.INTRODUCTION


 3   Dual-energy X-ray Absorptiometry (DXA) is primarily used in determination of bone mineral
 4   density; however its application has more recently been extended to include estimates of
 5   body fat content. It is performed on equipment specifically designed for and dedicated to
 6   these purposes.          Similar examinations are performed on CT with much higher doses
 7   (Kalender, 1995).

 8   For comparison of scanner results and longitudinal studies the accuracy of calibration is
 9   critical. The effect of software updates also needs to be monitored. However there are well
10   documented discrepancies between the results obtained on the scanners of major
11   manufacturers (Kelly, Slovik and Neer, 1989). Further work in this area is essential.

12           2.8.2.ACCEPTABILITY CRITERIA FOR DXA SYSTEMS


13   Table 2.20 Criteria of Acceptability for DXA Equipment
       Physical Parameter            Suspension Level                Reference             Type            Notes
      Patient Entrance             Less than 500 µGv for          Larkin et al (2008)       C        Normal from
      Dose                         spine examination.             Njeh et al (1999)                  survey is 20 –
                                                                  Sheahan (2005)                     200 µGv)
                                                                                                     Clinical Protocol –
                                   Outside +/- 50%                                                   standard.
                                   deviation from                                                    Worst case 35%
                                   manufacturers                                                     from Larkin paper
                                   specified nominal                                                 and 40% from
                                   patient dose                                                      Sheahan paper.
      Repeatability of                                                                               See Section 2.2
      Exposures
      BMD accuracy                 Outside 3% of                  Larkin et al (2008)        C       Standard protocol
                                   manufacturer’s                 Sheahan (2005)                     with supplier’s
                                   specified BMD                  BIR (2001)                         phantom.
                                                                  IAEA (2009)
                                                                  Sheahan et al
                                                                  (2005)
14

15

16


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 1                                 3. NUCLEAR MEDICINE EQUIPMENT


 2   The technical parts of Sections 2, 3, and 4 assume those reading and using them are
 3   familiar with the introduction and have a good working knowledge of the relevant types of
 4   equipment and appropriate testing regimes.

 5       3.1. INTRODUCTION


 6   The safe, efficient and efficacious practice of nuclear medicine involves the integration of a
 7   number of processes. The quality of each process will have an impact on the overall quality
 8   of the clinical procedure and ultimately on the benefit to the patient. It is important,
 9   therefore, that each process be conducted within the framework of a quality assurance
10   programme that, if followed, can be shown to achieve the desired objectives with the
11   desired accuracy.

12   The levels of activity in radiopharmaceuticals to be administered clinically are governed
13   primarily by the need to balance the effectiveness and the safety of the medical procedure
14   by choosing the minimum absorbed dose delivered to the patient to achieve the required
15   objective i.e. diagnostic image quality or therapeutic outcome. To realize this goal, it is
16   important to keep in mind that a nuclear medicine procedure consists of several
17   components, all of which must be controlled in order to have an optimal outcome.

18   Although the quality assurance of radiopharmaceuticals is an important process (IAEA,
19   2006), it is not an objective of this section. However, the performance testing of the
20   equipment needed to carry out the quality assurance of radiopharmaceuticals is an
21   objective, both for therapeutic and diagnostic procedures. Devices are included for the
22   determination of administered dose and radiochemical purity such as activity measurement
23   instruments (activity meter or dose calibrator), gamma counter, thin layer chromatography
24   scanner and high performance liquid chromatography radioactivity detector.

25   More specifically the objective of this section is to specify acceptable performance tolerance
26   levels (suspension levels) for the equipment used in Nuclear Medicine procedures, both for
27   gamma camera and positron emission based procedures. In-vitro Nuclear Medicine



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 1   diagnostic equipment and instruments are not covered since these do not contribute to the
 2   patient exposure.

 3   Some Positron Emission Tomography Installations have in-house production of the
                                                                                18
 4   radiopharmaceuticals they use (e.g. FDG labelled with                           F), utilising either self-shielded
 5   cyclotrons or cyclotrons placed in specially designed bunkers. This activity is regarded as a
 6   radiopharmaceutical manufacturing activity and therefore is outside the scope of this report.

 7   This section also covers the instruments needed for therapeutic procedures and intra-
 8   operative probes, since these are used directly on the patient to trace the administered
 9   radioactivity.

10   When equipment no longer meets the required performance specifications (suspension
11   levels), it should be withdrawn from use, may be disposed of, and replaced (Article 8 (3) of
12   Council Directive 97/43/Euratom). Alternatively, following a documented risk assessment
13   involving the MPE and the Physician, equipment may be used for less demanding tasks for
14   which a lower specification of performance is acceptable. The operator must be advised of
15   the circumstances.

16   The suspension levels stated are intended to assist in the decision making process
17   regarding the need for recalibration, maintenance or removal from use of the equipment
18   considered.

19   This section considers equipment used for:

20       1 Nuclear medicine therapeutic procedures

21       2 Radiopharmacy quality assurance programme

22       3 Gamma camera based diagnostic procedures

23       4 Positron emission diagnostic procedures

24       5 Hybrid diagnostic systems

25       6 Intra-operative probes


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 1   Each part of this section is comprised of a brief introduction and a list of relevant equipment.
 2   For each piece of equipment, a brief introduction, a table with the critical performance
 3   parameters and the suspension levels are given. References to recommended test
 4   methods for each parameter are also given.

 5       3.2. NUCLEAR MEDICINE THERAPEUTIC PROCEDURES


 6           3.2.1.INTRODUCTION


 7   Unsealed radioactive sources are administered to patients orally, intravenously or injected
 8   into various parts of the body for curative or palliation purposes. The management of the
 9   patient depends on the activity and radionuclide used to give the prescribed absorbed dose.
10   It may be necessary for the patient to be confined into a specially designed room for a few
11   days before being released from the hospital to provide radiation protection to hospital staff
12   and members of the public.

13   When working with unsealed radioactive sources, contamination always presents a
14   potential hazard. Such contamination may come from persons working with the radioactive
15   sources or from patients who have been treated with these substances. Such contamination
16   presents a hazard to anybody coming into contact with it and should be avoided if at all
17   possible, monitored and controlled if it occurs.

18   The patient undergoing treatment with unsealed radioactive sources must also be checked
19   before he/she is released from hospital to determine that the dose rate from his/her body is
20   down to acceptable levels for members of the public.

21   Three types of equipment that are used in Nuclear Medicine therapeutic procedures are
22   considered in this part. These are:

23       •   Activity measurement instruments

24       •   Contamination monitors

25       •   Patient dose rate measuring instruments




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 1            3.2.2.ACTIVITY MEASUREMENT INSTRUMENTS


 2    Many different radionuclides are used for Nuclear Medicine therapeutic procedures. The
 3    amount of activity to be administered to the patient must be determined accurately. Activity
 4    measurement instruments, commonly known as Isotope Calibrators or Dose Calibrators,
 5    must be capable of measuring the activity of a particular radionuclide (gamma or beta
 6    emitting) accurately over a wide range of energies for correct determination of the patient
 7    dose. They must also be capable of measuring accurately over a wide range of activities.

 8    The performance of activity measurement instruments must be assured through a quality
 9    assurance programme conforming to international standards (IEC, 1994c; IEC, 2006). The
10    suspension levels are given in Table 3.1 for each critical parameter together with the type of
11    criterion used and a reference to a recommended test method.

12    Table 3.1 Suspension Levels for Activity Measurement Instruments

         Physical Parameter                  Suspension Level                          Reference                   Type
     Background response                    > 1.5 X Usual                IEC (2006) (section 4.1)                    C
                                            Background                   IEC (1994c) (section 8)
     Constancy of instrument                ± 10%                        IEC (2006) (section 4.2)                    C
     response
     Instrument Accuracy                    ± 10%                        IEC (1994c) (section 3)                     C
     Instrument Linearity                   ± 10%                        IEC (2006) (section 4.3)                    C
                                                                         IEC (1994c) (section 4)
     System reproducibility                 ± 10%                        IEC (1994c) (section 5)                     C
     Sample volume characteristics          ± 15%                        IEC (1994c) (section 7)                     C
     Long-term reproducibility              ± 10%                        IEC (1994c) (section 9)                     C
13

14    The suspension levels given in the above table are for instruments used for the
15    measurement of the activity of gamma emitting sources with energies above 100keV. If
16    these instruments are calibrated to measure low gamma ray energies (below 100 keV),
17    beta or alpha emitting sources (Siegel et al, 2004) and the instrument is suspected of
18    malfunctioning then a test with a relevant source needs to be carried out to confirm the
19    suspicion using the values in the above table.

20            3.2.3.CONTAMINATION MONITORS


21    The contamination monitor (also called area survey meter) is designed for the detection and
22    measurement of radioactivity (alpha, beta and gamma) on the surface of objects, clothing,
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 1   persons etc. It is used wherever contamination by radioactive substances may be
 2   encountered and has to be monitored routinely.

 3   The determination of a monitor’s (instrument’s) performance can be at different levels of
 4   complexity (ICRU, 1992). A more detailed level is required for the evaluation or type testing
 5   of a particular monitor design. Once the monitor has been type tested, less extensive
 6   procedures can be used to establish either that a given monitor has maintained its
 7   calibration or that it has the same characteristics as the original type tested monitor (IEMA,
 8   2004; IPSM, 1994). The complexity of the procedure depends on what information is
 9   required and is generally intermediate between that required by a full type test and a simple
10   reproducibility check.

11   The suspension levels are given in Table 3.2 for each critical parameter of contamination
12   monitors together with the type of criterion used and the reference to a recommended test
13   method.

14   Table 3.2 Suspension Levels for Contamination Monitors
        Physical Parameter                    Suspension Level                         Reference                 Type
     Sensitivity                         > 1.2 X Usual Background              IEC (2001a) (section 4.2)          B
     Monitor Linearity                   ± 20%                                 IPSM (1994) (section 3.3)          B
                                                                               IEC (2006) (section 4.3)
                                                                               IEC (1994c) (section 4)
     Statistical Fluctuation of ± 20%                                          IPSM (1994) (section 3.4)          B
     Reading
     Monitor Response Time      ± 10%                                          IPSM (1994) (section 3.5)          B
     Energy Dependence of ± 20%                                                IPSM (1994) (section 3.6)          B
     Monitor
15

16   There is a large variation between the different types of contamination monitors. The above
17   suspension levels are a compromise and in some cases may be considered as too
18   conservative.

19           3.2.4.PATIENT DOSE RATE MEASURING INSTRUMENTS


20   A patient who has been administered with a therapeutic amount of activity of a radionuclide
21   becomes a radioactive source and may need to be confined in a specially designed room
22   for a few days before being safe to be released from hospital. The monitoring of the patient

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 1   dose rate is very important when gamma radiation is being emitted that can irradiate other
 2   persons at a distance from the patient. Therefore, the gamma dose rate of the patient is
 3   measured at a standard distance and should be below the acceptable level before the
 4   patient is released from hospital.

 5   The performance of a patient dose rate measuring instrument must be assured through a
 6   continuous quality assurance programme conforming to international standards (IEMA,
 7   2004) and other commonly acceptable reports (ICRU, 1992; IPSM, 1994). The suspension
 8   levels are given in Table 3.3 for each critical parameter.

 9   Table 3.3 Suspension Levels for Patient Dose Rate Measuring Instruments
          Physical Parameter      Suspension Level                                Reference                          Type
     Instrument     Dose   Rate ± 20%                                 IPSM (1994) (section 3.3)                       C
     Linearity                                                        IEC (2006) (section 4.3)
                                                                      IEC (1994c) (section 4)
     Statistical Fluctuation of ± 20%                                 IPSM (1994) (section 3.4)                       C
     Reading
     Instrument    Dose     Rate ± 10%                                IPSM (1994) (section 3.5)                       C
     Response Time
     Energy     Dependence    of ± 20%                                IPSM (1994) (section 3.6)                       C
     Instrument
10

11   There is a large variation between the different types of patient dose rate measuring
12   instruments. The above suspension levels are a compromise and in some cases may be
13   considered as too conservative.

14            3.2.5.RADIOPHARMACY QUALITY ASSURANCE PROGRAMME


15   The quality of the radiopharmaceutical administered to the patient has to be such that it will
16   not cause adverse effects to the patient, expose the patient to unnecessary radiation and at
17   the same time be specific for the organ of interest. As the injected radiopharmaceutical
18   circulates in the blood system before it is absorbed and preferentially concentrated in the
19   target    organ/tissue,        other     organs/tissues        of    the    body      absorb        some   of    the
20   radiopharmaceutical and therefore receive an absorbed dose related to the amount of
21   radiopharmaceutical. Penetrating radiation from the target organ/tissue also irradiate other
22   organs/tissues. Therefore, the maximum amount administered should not exceed the


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 1   recommended local Derived Reference Levels (DRLs). Poor radiochemical purity will also
 2   result in radioactivity going to non-target organs and irradiate them unnecessarily.

 3   Also different radiopharmaceuticals are used depending on the imaging modality used (PET
 4   or SPECT). Furthermore, for a specific examination there may be more than one
 5   radiopharmaceutical that can be used to acquire the final image.

 6   Taking the above into consideration the administered activity to the patient must be
 7   prepared in a specially designed room, the radiopharmacy (also called the Hot Laboratory),
 8   under a strictly controlled written procedure. The performance of the instruments used in
 9   the preparation must be assured under a quality control programme.

10   The type and number of instruments required in a radiopharmacy will depend on the
11   number of modalities available in a Nuclear Medicine Department and the variety of
12   radiopharmaceuticals and procedures used. For simplicity these are divided into two
13   categories:

14         1.    Radiopharmacy for gamma camera based diagnostic procedures

15         2.    Radiopharmacy for positron emission based diagnostic procedures

16   In cases were both gamma camera based and positron emission modalities are available,
17   the radiopharmacy will need to have instruments capable for accommodating both types of
18   radiopharmaceuticals, either in a single instrument or different instruments for each type.

19         3.3. RADIOPHARMACY FOR GAMMA CAMERA BASED DIAGNOSTIC PROCEDURES


20              3.3.1.INTRODUCTION


21   The objective of this part is to define suspension levels for the performance parameters of
22   the        equipment    needed       to    carry     out     the    quality     assurance           programme    for
23   radiopharmaceuticals used with gamma camera based modalities. These include devices
24   used for radiochemical purity determination such as the activity measurement instrument,
25   the gamma counter and the thin layer chromatography scanner.

26   The availability of the above equipment in a radiopharmacy depends on the level and
27   sophistication of its activities.
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 1   For the protection of the personnel working in a radiopharmacy, instruments such as
 2   contamination monitors are also essential. Therefore this part considers the following
 3   instruments:

 4       •   Activity Measurement Instruments

 5       •   Gamma Counters

 6       •   Thin Layer Chromatography Scanners

 7       •   Contamination Monitors

 8           3.3.2.ACTIVITY MEASUREMENT INSTRUMENTS


 9   The activity measurement instruments that are used for gamma camera based diagnostic
10   procedures need to cover the energy range and activity range of the radiopharmaceuticals
11   that are used in the particular department. The quality assurance programme that must be
12   followed to assure their performance, as well as the suspension levels are the same as
13   those described in section 3.2.2, under “Activity measurement instruments”.

14           3.3.3.GAMMA COUNTERS


15   These are single “well type” gamma counters used in the radiopharmacy to measure the
16   activity (number of counts per second) on the paper chromatography strips used for the
17   radiochemical purity testing of radiopharmaceuticals. These are similar to gamma counters
18   for in-vitro diagnostic investigations and are used to compare the number of counts of the
19   different sections of the paper chromatography strips.

20   The performance of a gamma counter must be assured through a continuous quality
21   assurance programme conforming to international standards (IEC, 2009) and other
22   commonly accepted reports (ICRU, 1992; IPSM, 1994). The suspension levels are given in
23   Table 3.4 for each critical parameter of a well type gamma counter.

24
25
26
27

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 1   Table 3.4 Suspension Levels for Well Type Gamma Counters
       Physical Parameter          Suspension Level               Reference                                      Type
     Sensitivity                >    1.5   X    Usual IEC (2001a) (section 4.2)                                   C
                                Background
     Instrument Dose Rate ± 20%                       IPSM (1994) (section 3.3)                                    C
     Linearity                                        IEC (2006) (section 4.3)
                                                      IEC (1994c) (section 4)
     Statistical Fluctuation of ± 20%                 IPSM (1994) (section 3.4)                                    C
     Reading
     Instrument Dose Rate ± 10%                       IPSM (1994) (section 3.5)                                    C
     Response Time
     Energy Dependence of ± 20%                       IPSM (1994) (section 3.6)                                    C
     Instrument
     Sample            Volume ± 15%                   IEC (1994c) (section 7)                                      C
     Characteristics
 2

 3   The above suspension levels are a compromise and in some cases may be considered as
 4   too conservative.

 5   Test methods that can be used to monitor a gamma counter are similar to those of patient
 6   dose rate measuring instruments. The test method for sensitivity is similar to that of
 7   contamination monitors. The test method for volume dependence of the well type gamma
 8   counters is similar to that of the activity measurement instruments.

 9           3.3.4.THIN LAYER CHROMATOGRAPHY SCANNERS


10   A thin layer chromatography scanner is a gamma counter that simultaneously measures or
11   scans the length of the paper chromatography strip and calculates automatically the count
12   ratio as a measure of radiochemical purity.

13   The suspension levels of each critical parameter of a thin layer chromatography scanner
14   are similar to those of a gamma counter (Table 3.4).

15           3.3.5.CONTAMINATION MONITORS


16   The contamination monitors usually encountered in a radiopharmacy take the form of
17   continuous room monitors for air borne contamination and for the contamination of hands
18   and clothes of the personnel working in the radiopharmacy. The quality assurance


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 1   programme that must be followed to assure their performance is the same as that described
 2   for contamination monitors (see section 3.2.3).

 3       3.4. RADIOPHARMACY FOR POSITRON EMISSION BASED DIAGNOSTIC
 4             PROCEDURES


 5   The specific radioactivity of the radiopharmaceutical is an important factor to consider in
 6   guaranteeing the quality of a PET study (Nakao et al, 2006). Chemical impurities in
 7   radiopharmaceuticals, such as precursors and analogues contained in the preparation, may
 8   interfere with the PET study (and may cause adverse reactions in the patient). Therefore it
 9   is necessary to measure the specific activity and chemical impurities accurately before
10   administration.

11   Due to the very short half-lives of PET radionuclides, quality control is carried out by their
12   producer and they are delivered to the hospital ready for patient administration.

13   The instruments usually found in a hospital PET radiopharmacy are the same as those for
14   gamma camera based diagnostic procedure radiopharmacy (Section 3.3.1), calibrated for
15   the specific PET radionuclides used in a particular hospital. Additionally, in hospital
16   research departments, one may find instruments such as High Performance Liquid
17   Chromatography (HPLC), Gas Chromatography (GC) and Thin Layer Chromatography
18   (TLC) that are used to verify the specific activity, the radiochemical and chemical purity of
19   the radiopharmaceutical used (Dietzel, 2003). There are also all-in-one instrument that
20   perform these analyses at the same time. These analysers need to meet Good
21   Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulation criteria
22   (OECD, FDA) (Dietzel, 2003).

23   Currently there are no commonly acceptable suspension levels for such instruments and
24   therefore the manufacturer’s recommendations for each specific instrument should be used.

25       3.3     GAMMA CAMERA BASED DIAGNOSTIC PROCEDURES


26             3.3.1   INTRODUCTION


27   The gamma camera is currently available in a number of configurations capable not only of
28   performing simple Planar Imaging (Section 3.4.2) but also of Whole Body Imaging (Section
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 1   3.4.3) and Single Photon Emission Computed Tomography (SPECT) (Section 3.4.4). Some
 2   dual headed Gamma Cameras with appropriate coincidence circuits and software are also
 3   capable of performing Positron Emission Tomography (Section 3.4.5). However, the PET
 4   Scanner dealt with in section 3.5 is rapidly replacing such systems.

 5   The IEC (IEC, 2005c; IEC, 2004b, 1998b, c) and the National Electrical Manufacturers
 6   Association (NEMA) (NEMA, 2007a, b) in the USA have published relevant standards.
 7   These are almost identical with respect to many test procedures, test objects and
 8   radioactive sources and have been used extensively. The IEC and NEMA standards were
 9   aimed primarily at manufacturers but are now more orientated towards user application than
10   previous publications making it easier to test for compliance in the field. The NEMA
11   Standard also includes directions for the testing of Gamma Cameras with discrete Pixel
12   Detectors. In this section the suspension levels are mainly related to manufacturer’s
13   specifications, Type A Criteria. The NEMA standards require that the system “meet or
14   exceed” the manufacturer’s specification unless the specification is considered “typical
15   performance”. “Typical” specifications are used when the measurement is sufficiently time-
16   consuming that measuring large numbers of units is difficult. For these tests greater
17   suspension levels have been proposed.

18   In addition to the standards, there are a number of publications on quality control that
19   provide a wealth of useful background material and detailed accounts of test methods and
20   phantoms for routine assessment which must be undertaken on a regular basis according
21   to national protocols (IPEM, 2003b; AAPM, 1995).

22           3.4.1.PLANAR GAMMA CAMERA


23   Gamma cameras are normally operated with collimators appropriate to the study being
24   performed. Tests performed with collimators in situ are termed ‘system’ tests. Tests
25   performed without collimators are ‘intrinsic’ tests. Since there is a large range of different
26   types of collimator in use and their characteristics vary from type to type and from
27   manufacturer to manufacturer, professional judgement may have to be called on with
28   respect to system tests for a particular collimator. It is important to perform system non-
29   uniformity tests on all collimators in clinical use in order to detect collimator damage at the
30   earliest opportunity (IEC, 2005b)


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 1   Table 3.5 Suspension Levels for Planar Gamma Systems
          Physical Parameter           Suspension Level                       Reference                       Type
        Intrinsic Spatial              >1.05 times the            IEC (2005a), Section 4.5                     A
        Resolution                     manufacturer’s             NEMA (2007a), Sections 2.1 and 2.7
                                       specification
        Intrinsic Spatial Non-         >1.05 times the            IEC (2005a), Section 4.4                      A
        Linearity                      manufacturer’s             NEMA (2007a) Sections 2.2 and 2.7
                                       specification
        Intrinsic Non-uniformity       >1.05 times the            IEC (2005a), Section 4.3                      A
                                       manufacturer’s             NEMA (2007a), Sections 2.4 and 2.8
                                       specification
        Intrinsic energy               >1.05 times the            IEC (2005a), Section 4.6                      A
        resolution                     manufacturer’s             NEMA (2007a), Section 2.3
                                       specification
        Multiple window spatial        >1.05 times the            IEC (2005a), Section 2.5                      A
        registration                   manufacturer’s             NEMA (2007a), Section 4.7
                                       specification
        Intrinsic count rate           <0.9 times the             NEMA (2007a), Section 2.6                     A
        performance in air             manufacturer’s
                                       specification
        System Spatial                 >1.05 times the            IEC (2005a), Section 4.3                      A
        Resolution with scatter        manufacturer’s             NEMA (2007a), Section 3.2
                                       specification
        System Non-uniformity          >1.05 times the            IEC (2005a), Section 4.5                      A
                                       manufacturer’s
                                       specification
 2

 3           3.4.2.WHOLE BODY IMAGING SYSTEM


 4   The IEC 61675-3 standard (IEC, 1998c) and the NEMA Standard NU-1 (NEMA, 2007a)
 5   contain a limited number of tests for Whole Body Systems. Before performing these specific
 6   tests, it is advisable that the basic tests for the Planar Gamma Camera are performed for
 7   each detector head used for whole body imaging (Table 3.5).

 8
 9
10
11
12
13



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1   Table 3.6 Suspension Levels for Whole Body Imaging Systems
     Physical Parameter              Suspension Level                           Reference                       Type
    Whole body non-             >10% difference between this          IPEM (2003b) Section 4.2.1                 B
    uniformity                  and planar system uniformity
    Whole Body Spatial          >1.05 times the                       IEC (1998c), Section 3.2                    A
    Resolution Without          manufacturer’s specification          NEMA (2007a), Section 5.1
    Scatter
    Scanning constancy          Any deviation in mean count           IEC (1998c), Section 3.1                    A
                                rate greater than expected
                                from Poisson statistics
2

3           3.4.3.SPECT SYSTEM


4   The IEC 61675-3 standard (IEC, 1998c) and the NEMA Standard NU-1 (NEMA, 2007a)
5   both contain a section devoted to SPECT systems. The basic tests for Planar Gamma
6   Camera systems should be performed on each detector head used for SPECT before
7   commencing with the tests specific for SPECT.




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 1   Table 3.7 Suspension Levels for SPECT Systems
       Physical Parameter             Suspension Level                         Reference                        Type
     Centre of Rotation             COR X axis offset:             IEC (2004d), (1998b), Sections 3.1.1          A
     (COR) and Detector             >1.05 times the                and 3.1.2
     Head Tilt                      manufacturer’s                 NEMA (2007a), Section 4.1
                                    specification                  IAEA (2007c) Section 4.3.3
                                    For Multiple head              IPEM (2003b) Section 5.3.2
                                    systems offsets >5%
                                    Mismatch Y axis >5%
                                    between detectors
     Collimator Hole                >1.05 times the                IEC (2004d), (1998b), Section 3.2              A
     Misalignment                   manufacturer’s                 IAEA (2007c), Section 3.3.6
                                    specification                  IPEM (2003b) Section 5.3.3
     SPECT System Spatial           >1.05 times the                IEC (2004d), (1998b), Section 3.6              A
     Resolution                     manufacturer’s                 NEMA (2007a), Section 4.3
                                    specification
     Detector to Detector           >1.1 times the                 NEMA (2007a), Section 4.5                      A
     Sensitivity Variation          manufacturer’s
                                    specification
     Variation of Response          ≥1.5%                          AAPM (1995), Section III.A.1                   A
     with Detector Rotation                                        IPEM (2003b) Section 5.3.7

 2


 3           3.4.4.GAMMA CAMERAS USED FOR COINCIDENCE IMAGING


 4   The basic tests for Planar Gamma Camera Systems should be performed on each detector
 5   (Table 3.5). However, the thicker crystals required for these cameras do not perform as well
 6   with respect to intrinsic spatial resolution as the thinner crystals intended mainly for use with
 7   technetium-99m based radiopharmaceuticals (Table 3.8). Tolerances for the other tests are
 8   the same as those in Table 3.6.

 9
10
11
12
13
14
15
16



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 1   Table 3.8 Suspension Levels for Coincidence Gamma Camera Systems
       Physical Parameter              Suspension Level                         Reference                        Type
     Intrinsic Spatial              >1.05 times the                 IEC (2005a), Section 4.5                      A
     Resolution                     manufacturer’s                  NEMA (2007a), Sections 2.1 and 2.7
                                    specification [A]
     System Spatial                 >1.05 times the                 IEC (2005a), Section 4.3                       A
     Resolution                     manufacturer’s                  NEMA (2007), Section 3.2
                                    specification [A]
 2

 3       3.5. POSITRON EMISSION DIAGNOSTIC PROCEDURES


 4              3.5.1.INTRODUCTION


 5   Positron Emission Tomography (PET) is a nuclear medicine imaging technique that utilises
 6   positron-emitting radionuclides, normally produced in a cyclotron. The most frequent clinical
 7   indication for a PET scan today is in the diagnosis, staging, and monitoring of malignant
 8   tumours. Other indications include assessment of neurological and cardiological disorders.

 9   The PET technology has evolved rapidly in the past decade. Two significant advances have
10   greatly improved the accuracy of PET imaging:

11       (i)       the introduction of faster scintillation crystals and electronics which permit higher
12                 data acquisition rates, and,

13       (ii)      the combination, in a single unit, of PET and CT scanners (“hybrid” scanners, see
14                 section 3.6).

15   It is expected that the utilisation of PET will increase dramatically in the future. In some
16   cases it may substitute for current nuclear medicine investigations but, in general, PET will
17   be complementary to the use of single photon imaging with the gamma camera.

18   The purpose of this section is to specify Suspension levels for PET scanners to be used in
19   clinical imaging. Note that these technical requirements relate to clinical facilities and are
20   not intended to apply to research installations.




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 1           3.5.2.POSITRON EMISSION TOMOGRAPHY SYSTEM


 2   PET is based on the coincidence detection of two oppositely directed 511 keV photons
 3   emitted from the annihilation of a positron with an atomic electron in vivo. The detection of
 4   such events, known as true coincidences, is used for the reconstruction of an image
 5   describing the in vivo distribution of a positron emitting radiopharmaceutical. Apart from
 6   these events, there are also other types of erroneous coincidences that may be detected,
 7   namely scattered and random coincidences. Scattered coincidences are events formed by
 8   detection of two annihilation photons, where at least one has undergone Compton
 9   scattering before detection (but still are detected in the energy window), while random
10   coincidences are formed when two photons originating from two different annihilation sites
11   are detected within the system’s coincidence time window.

12   The performance of PET systems must be assured through a continuous quality assurance
13   programme conforming to international standards (IEC, 2008c; NEMA, 2007b; IEC, 2005)
14   and other commonly accepted reports (IAEA, 2009). The suspension levels are based on
15   Type A Criteria. These are given in Table 3.9 for each critical parameter of PET systems.




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 1   Table 3.9 Suspension Levels for PET Systems
       Physical Parameter                  Suspension Level                         Reference                   Type
     Spatial Resolution               FWHMobserved                           NEMA (2007b) (section 3.3)          A
                                      >1.05*FWHMexpected
     Sensitivity                                                             NEMA (2007b) (section 5.3)           A
                                      STOT observed < 0.95*STOT expected     IEC (2008d) (section 3.3)
                                                                             IEC (2005b) (section 4.2)
     Energy resolution                REobserved > 1.05*REexpected           IAEA (2007c) (section                A
                                                                             4.1.4)
     Scatter fraction, count          NECobserved <NEC Recommended           NEMA (2007b) (section 4.3)           A
     losses and random                SFobserved > 1.05*SFexpected           IEC (2008d) (section 3.6)            A
     measurements                                                            IAEA (2007c) (section
                                                                             4.1.3)
     Uniformity                       %NUobserved >                          NEMA (2007b) (section 7.3)           A
                                      1.05*%NUexpected
     Image quality and                Unacceptable visual                    IAEA (2007c) (section                A
     accuracy of attenuation          assessment                             5.1.4)
     and scatter correction
     Coincidence timing               RTobserved > 1.05*RTexpected           IAEA (2007c) (section                A
     resolution (TOF)                                                        4.1.6)
     Mechanical Tests            If any mechanical part is                              C
                                 found to compromise the
                                 safety of operation
 2   *   Expected and recommended values are the values for each parameter measured or agreed
 3       during the acceptance testing.
 4       FWHM = Full Width at Half Maximum

 5           3.5.3.HYBRID DIAGNOSTIC SYSTEMS


 6   A hybrid diagnostic system is defined as the combination of two diagnostic modalities into
 7   one system. Examples of such systems are PET-CT, SPECT-CT, PET-MRI, etc. Usually
 8   one modality presents functional (molecular) images and the other anatomic images. The
 9   fusion (combination) of their images gives a higher diagnostic value than the individual
10   images alone.

11   The quality control procedures of each individual modality comprising the hybrid system are
12   well established and if followed as recommended, the hybrid system will operate optimally.
13   The suspension levels for the individual modalities are valid for the hybrid systems as well.
14   The only concern with hybrid systems even today, is the alignment of the imaging
15   modalities of the hybrid system. Here it is recommended that an independent alignment



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 1   test, using a phantom in the place of a patient, be used at regular intervals to assure the
 2   alignment of the modalities comprising the hybrid system (NEMA, 2007b; Nookala, 2001).

 3   The suspension level is based on Type C Criteria and is given in Table 3.10 for the
 4   alignment of a hybrid system.

 5   Table 3.10 Suspension Level for the Alignment of Hybrid Systems
          Physical Parameter               Suspension Level                       Reference                    Type
        Alignment Test of a             > ± 1 pixel or ± 1 mm,          Nookala (2001)                          C
        Hybrid System                   whichever is bigger
 6

 7       3.4     INTRA-OPERATIVE PROBES


 8   Radiotracer techniques using intra-operative gamma probes are procedures that surgeons
 9   can use to more easily localise small tumours or lymph nodes to be removed in a surgical
10   procedure. Use of intra-operative probes decreases operating time, decreases patient
11   morbidity and improves staging accuracy. All of these can lead to improved treatment,
12   improved quality of life and higher long-term survival rates (Halkar and Aarsvold, 1999).

13   The most established type of intra-operative probe is the non-imaging gamma probe. Other
14   types such as imaging intra-operative probes and beta probes are less well established or
15   are still under development and therefore their performance parameters are less rigorously
16   defined. Furthermore a wide range of gamma probe systems are commercially available
17   with different detector material, detector sizes and collimator abilities. Various methods of
18   evaluation of such equipment have been proposed (NEMA, 2004; IEC, 2001a). For these
19   reasons suspension levels to cover all the types of intra-operative probes do not exist.

20   For the most common application, that of the detection of the sentinel lymph node (SLN),
21   minimum requirements of a gamma probe system has been recommended (Wengenmair
22   and Kopp, 2005; Yu et al, 2005). These were derived mainly from comparison studies of
23   commercially available probe systems and are presented in Table 3.11. It is recommended
24   that the user of a particular probe system establish a quality assurance system for the
25   probe system in use and establish suspension levels taking into account the manufacturer’s
26   recommendations.


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1   Table 3.11 Suspension Levels for a SLN intra-operative gamma probe system
              Physical            Suspension Level                             Reference                      Type
            Parameter
       Radial Sensitivity        FWHM > 40o                  Wengenmair and Kopp (2005)                         C
       (far field)                                           NEMA (2004) (section 3.9)
       Spatial Resolution        FWHM >15mm for              Wengenmair and Kopp (2005)                         C
                                 lymph nodes in head,        NEMA (2004) (section 3.5)
                                 neck and
                                 supraclavicular
                                 region
                                 FWHM > 20mm for
                                 lymph nodes in
                                 extremities, axilla and
                                 groin
       Sensitivity               < 5.5 cps/kBq               Wengenmair and Kopp (2005)                         C
                                                             NEMA (2004) (section 3.1 – 3.4)
       Shielding                 > 0,1 of minimum            Wengenmair and Kopp (2005)                         C
                                 system sensitivity
2




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 1                                             4       RADIOTHERAPY


 2   The technical parts of Sections 2, 3, and 4 assume those reading and using them are
 3   familiar with the introduction and have a good working knowledge of the relevant types of
 4   equipment and appropriate testing regimes.

 5       3.6. INTRODUCTION


 6   The purpose of this document is to list performance parameters and their tolerances.
 7   Specific reference is not made to safety requirements, but these need to be checked at
 8   acceptance and after maintenance and upgrades and may result in suspension of the
 9   equipment during operation, if not met.

10   These functional performance tolerances reflect the need for precision in radiotherapy and
11   the knowledge of what can be reliably achieved with radiotherapy equipment. The
12   tolerances presented must be used as suspension levels at which investigation must be
13   initiated, according to the definition in section 1.4.2. Where possible, it will be necessary to
14   adjust the equipment to bring the performance back within tolerance limits. If adjustment is
15   not possible, e.g. loss of isocentric accuracy, it may still be justified to use the equipment
16   clinically for less demanding treatments. Such a decision can only be taken after careful
17   consideration by the clinical team (responsible medical physics expert and radiation
18   oncologist) and must be documented as part of an agreed hospital policy. Alternatively it
19   should be suspended from use until performance is restored. Suspension from use can also
20   be required if the safety requirements in the relevant safety standards are not met.

21   In the following clauses these levels are referred to as performance tolerance levels, as this
22   is the terminology used in the quoted IEC standards. However, in the tables these levels
23   are listed as tolerance/suspension levels as they correspond also with the definition of
24   suspension level in section 1.4.2 and used in the other sections of this document.

25   The performance tolerance/suspension levels quoted in this section have been extracted
26   mostly from international and national standards (category type A), supplemented by
27   guidance from national professional bodies (category type B) (see section 1.4.3).
28   Tolerances are expressed in the same format (e.g. ± or maximum deviation) as originally
29   given in the quoted standards and guidance documents.
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 1   All test equipment used in measuring functional performance must be well maintained,
 2   regularly calibrated and traceable (where appropriate) to national standard laboratories.

 3       3.3     LINEAR ACCELERATORS


 4   IEC 60601-2-1 (1998a) is the standard which identifies those features of design that are
 5   regarded as essential for the safe operation of the equipment and places limits on the
 6   degradation on the performance beyond which a fault condition exists. These include
 7   protection against electrical and mechanical hazards and unwanted and excessive radiation
 8   hazards (i.e. dose monitoring systems, selection and display of treatment related
 9   parameters, leakage radiation and stray radiation).

10   IEC 60976 (2007) and IEC 60977 (2008c) are closely related to this standard. The former
11   specifies test methods and reporting formats for performance tests of medical electron
12   accelerators for use in radiotherapy, with the aim of providing uniform methods of doing so.
13   The latter is not a standard per se but suggests performance values, measured by the
14   methods specified in IEC 60976 (2007) that are achievable with present technology.

15   The values given in Table 4.1 are a summary of the tolerance values in IEC 60977 (2008c)
16   and are based on the methodology in IEC 60976 (2007). These values are broadly
17   consistent with the tolerances previously specified in IPEM 81 (1999), AAPM Report 46
18   (1994) and CAPCA standards (2005a). For a detailed description of test methods and
19   conditions, please refer to the IEC and IPEM documents. A list of suggested test equipment
20   is included in IEC 60977 (2008c). The table is intended to include the performance
21   parameters of all treatment devices incorporating a linear accelerator. All tests form part of
22   acceptance testing. Where tests are performed routinely for quality control, suggested
23   frequencies of testing are given in IEC 60977 (2008c), IPEM 81 (1999), AAPM Report 46
24   (1994), CAPCA standards (2005a) and other national QA protocols.

25   In the table, “IEC” refers to IEC 60976 (2007) and 60977 (2008c) and the numbers in the
26   Reference column refer to the clauses in these publications. “IPEM (1999)” refers to tables
27   in its section 5.2.




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1   Table 4.1 Summary of functional performance characteristics with tolerance/suspension
2   values for acceptance testing and quality control of a medical electron accelerator

                  Physical Parameter                           Tolerance/               Reference            Type
                                                               Suspension               (IEC (2007,
                                                                 Level                 2008c) unless
                                                                                           stated)
    Uniformity of radiation fields                                                 9
    X-ray beams
           Beam flatness in flattened area                  1.06                                         A
           (max/min ratio)                                  (see also IEC)
           Beam symmetry (max/min ratio)                    1.03                                         A
           Dependence on gantry and collimator              See IEC                                      A
           angle
           Beam flatness at dmax                            See IEC                                      A
           Wedge fields
                  Maximum deviation of wedge                2%                     IPEM (1999)           B
                  factor
                  Maximum deviation of wedge                3%                     IPEM (1999)           B
                  factor with gantry angle
                  Maximum deviation of wedge                2°                                           A
                  angle
           IMRT                                             See IEC                                      A
    Electron beams
           Beam flatness                                    See IEC                                      A
             Dependence of flatness on gantry               3%                                           A
             and collimator angle
             Beam symmetry (max/min ratio)                  1.05                                         A
             Maximum surface dose (max/min                  1.09 See IEC                                 A
             ratio)
    Dose monitoring system                                                         7
    Calibration check                                       2%                                           A
    Reproducibility                                         0.5 %
    Proportionality                                         2%                     IPEM (1999) 1%        A, B
    Dependence on angular position                          2%                     IPEM (1999)           B
    Dependence on gantry rotation                           2%                                           A
    Stability of calibration within day                     2%                                           A
    Stability in moving beam radiotherapy                   See IEC                                      A
    Depth dose characteristics                              See IEC                8                     A
    X-ray beams
             Penetrative quality                            2%                     IPEM (1999)           B
             Depth dose and profile                         2%                     IPEM (1999)           B
    Electron beams                                                                                       A
           Minimum depth of dmax                            1 mm                                         A
             Practical range to 80% ratio                   1.6                                          A
             Penetrative quality                            3 % or 2 mm                                  A
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       Maximum relative surface dose                    100 %                                         A
       Stability of penetrative quality                 1 % or 2 mm
Indication of radiation fields                                                 10
X-ray beams                                                                                           A
         Numerical field indication              3 mm or 1.5 %                                        A
                                                 See also IEC
                  For MLCs                       3 mm or 1.5 %                                        A
                                                 See IEC
         Light field indication                  2 mm or 1 %                                          A
                                                 See also IEC
                  Centres of radiation field and 2 mm or 1 %                                          A
                  light field                    See also IEC
                  For MLCs                       2 mm or 1 %                                          A
                                                 See also IEC
                  For SRS/SRT                    0.5 mm                                               A
                                                 See also IEC
         Reproducibility                         2 mm
         SRS alignments                          0.5 mm                        See also IPEM          A, B
                                                 See IEC                       (1999)
Electron beams
         Light field indication                  2 mm                                                 A
Collimator geometry
         Parallelism of opposing edges           0.5°                                                 A
         Orthogonality of adjacent edges         0.5°                                                 A
         Beam centring with beam limiting        2 mm                                                 A
         system rotation
Light field
         Field size (10*10 cm2)                  2 mm                          IPEM (1999)            B
         Illuminance (minimum)                   25 lux                                               A
         Edge contrast ratio (minimum)           4.0                                                  A
Indication of the radiation beam axis                                          11
On entry
         X-rays                                  2 mm                                                 A
         Electrons                               4 mm                                                 A
         SRS                                     0.5 mm                                               A
On exit
         X-rays                                  3 mm                                                 A
         SRS                                     0.5 mm                                               A
Isocentre                                                                      12
Radiation beam axis                              2 mm                          IPEM (1999)          1 A, B
                                                                               mm
Mechanical isocentre                                    1 mm                   IPEM (1999)            B
Indication                                              2 mm
        SRS                                             0.5 mm                 IPEM (1999)      B
Distance indication                                                            13
Isocentric equipment                                    2 mm                   IPEM      (1999) A, B
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                                                                                    3mm
     Non-isocentric equipment                                5 mm                                         A
     Zero position of rotational scales                                             14
     Gantry rotation                                         0.5°                   IPEM (1999)           B
     Roll and pitch of radiation head                        0.1°                                         A
     Rotation of beam limiting system                        0.5°                   IPEM (1999)           B
     Isocentric rotation of the patient support              0.5°                                         A
     Table top rotation, pitch and roll                      0.5°                                         A
     Accuracy of rotation scales                             1°                     IPEM (1999)           B
     Congruence of opposed radiation fields                  1 mm                   15
     Movements of patient support                                                   16
     Vertical movements                                      2 mm                                         A
     Longitudinal and lateral movements                      2 mm                   IPEM (1999)           B
     Isocentric rotation axis                                1 mm                                         A
     Parallelism of rotational axes                          0.5°                                         A
     Longitudinal rigidity                                   5 mm                                         A
     Lateral rigidity                                        0.5° and 5 mm                                A
     Electronic imaging devices                                                     17
     Minimum detector frame time                             0.5 s                                        A
     Corresponding maximum frame rate                        2/s                                          A
     Minimum signal-to-noise ratio                           50                                           A
     Maximum imager lag
             Second to first frame                           5%                                           A
             Or fifth to first frame                         0.3 %                                        A
     Minimum spatial resolution                              0.6 lp/mm              IPEM (1999)           B
 1

 2   Detachable devices can be attached to either the treatment head or the couch. The former
 3   include shadow trays and micro-MLCs, and the latter include devices such as stereotactic
 4   frames, head shells, bite-blocks, etc. Where reproducible immobilisation and positioning of
 5   the patient is required, the positional tolerance of these devices should be 2 mm in general
 6   use and 0.5 mm for SRS.

 7       3.7. SIMULATORS


 8   IEC 60601-2-29 (2008b) is the standard which identifies those features of design that are
 9   regarded as essential for the safe operation of the equipment and places limits on the
10   degradation on the performance beyond which a fault condition exists. These include
11   protection against electrical and mechanical hazards and unwanted and excessive radiation
12   hazards. In a similar way to IEC 60976 (2007) and 60977 (2008c) for linear accelerators,
13   IEC 61168 (1993a) and IEC 61170 (1993b) specify test methods and functional
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 1   performance values for radiotherapy simulators. The functional performance requirements
 2   of radiotherapy simulators are directly related to the radiotherapy equipment being
 3   simulated.       The performance tolerances must therefore be at least equal to those
 4   considered appropriate for the radiotherapy equipment and in many instances must be
 5   better in order not to add to the total positioning errors. There are some differences from
 6   recommendations published by national physicists’ associations (IPEM (1999), AAPM
 7   (1994) and CAPCA standards (2005b). Where recommendations from these bodies are
 8   adopted they are indicated in the table

 9   The values given in Table 4.2 are a summary of the tolerance values in IEC 61170 (1993b)
10   and are based on the methodology in IEC 61168 (1993a). Where additional tolerances (e.g.
11   for MLC and SRS/SRT simulation) have been suggested in the more recent linear
12   accelerator standards IEC 60976 (2007) and 60977 (2008c) and IPEM (1999), these are
13   indicated in the table. For a detailed description of test methods and conditions, please refer
14   to the IEC and IPEM documents.

15   All tests form part of acceptance testing. Where tests are performed routinely for quality
16   control, suggested frequencies of testing are given in IEC 61170 (1993b), IPEM (1999),
17   AAPM (1994), CAPCA (2005b) standards and other national QA protocols.

18   In the table, “IEC” refers to IEC 61168 (1993a) and 61170 (1993b).




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1   Table 4.2 Summary of functional performance characteristics with tolerance/suspension
2   values for acceptance testing and quality control of a radiotherapy simulator
                   Physical Parameter                          Tolerance/                Reference              Type
                                                               Suspension              (IEC (1993a,b)
                                                                 Level                  unless stated)
     Indication of radiation fields
     Numerical field indication                             2 mm or 1.0 %            IPEM         (1999) A, B
                                                            See also IEC
               For MLCs                                     2 mm or 1.0 %            IEC         (2008c, A
                                                                                     2007)
     Light field indication                                 1 mm or 0.5 %                                   A
                                                            See also IEC
               Centres of radiation field and light         1 mm or 0.5 %            IPEM (1999)            A, B
               field                                        See also IEC
               For MLCs                                     1 mm or 0.5 %            IEC         (2008c, A
                                                                                     2007)
               For SRS/SRT                                  0.5 mm                   IEC         (2008c, A
                                                                                     2007)
     Reproducibility                                        1 mm                                         A
     SRS alignments                                         0.5 mm                   IEC         (2008c, A, B
                                                                                     2007)
                                                                                     IPEM (1999)
     Delineator geometry
              Parallelism of opposing edges                 0.5°                                            A
              Orthogonality of adjacent edges               0.5°                                            A
              Beam centring with beam limiting              2 mm                     IEC (2008c,            A
              system rotation                                                        2007)
     Light field
              Field size (10*10 cm2)                        1 mm                                            A
              Minimum illuminance                           50 lux                                          A
              Minimum edge contrast ratio                   4.0                                             A
     Indication of the radiation beam axis
     On entry                                               1 mm                     IPEM (1999)      B
              SRS                                           0.5 mm                   IEC      (2008c, A
                                                                                     2007)
     On exit                                                2 mm                                      A
               SRS                                          0.5 mm                   IEC      (2008c, A
                                                                                     2007)
     Isocentre
     Radiation beam axis                                    1 mm                     IPEM (1999)            A, B
                                                            See also IEC
     Mechanical isocentre                                   1 mm                     IPEM (1999)            B
     Indication                                             1 mm                     IPEM (1999)            B
             SRS                                            0.5 mm                   IPEM (1999)            B
     Distance indication
     From isocentre                                         1 mm                                            A
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     From radiation source                                  2 mm                                           A
     Image receptor to isocentre                            2 mm                                           A
     Zero position of rotational scales
     Gantry rotation                                        0.5°                     IPEM (1999)           B
     Roll and pitch of radiation head                       0.1°                     IEC (2008c)           A
     Rotation of delineator                                 0.5°                     IPEM (1999)           B
     Isocentric rotation of the patient support             0.5°                     IEC (2008c)           A
     Table top rotation, pitch and roll                     0.5°                     IEC(2008c)            A
     Accuracy of rotation scales                            1°                       IPEM (1999)           B
     Congruence of opposed radiation fields                 1 mm
     Movements of patient support
     Vertical movements                                     2 mm                                           A
     Longitudinal and lateral movements                     2 mm                     IPEM (1999)           B
     Isocentric rotation axis                               1 mm                                           A
     Parallelism of rotational axes                         0.5°                                           A
     Longitudinal rigidity                                  5 mm                                           A
     Lateral rigidity                                       0.5° and 5 mm                                  A
     Electronic imaging devices
     Minimum detector frame time                            0.5 s                    IEC (2008c,           A
                                                                                     2007)
     Corresponding maximum frame rate                       2/s                      IEC (2008c,           A
                                                                                     2007)
     Minimum signal-to-noise ratio                          50                       IEC (2008c,           A
                                                                                     2007)
     Maximum imager lag
           Second to first frame                            5%                       IEC (2008c,           A
                                                                                     2007)
              Or fifth to first frame                       0.3 %                    IEC (2008c,           A
                                                                                     2007)
     Minimum spatial resolution                             0.6 lp/mm                IPEM (1999)           B
                                                                                     10.2.6
     Radiographic QC
     Alignment of broad and fine foci images                0.5 mm                   IPEM (1999)           B
     Fluoroscopic QC
     Full radiographic and fluoroscopic tests                                        IPEM (1999)           B
     Alignment of Shadow Trays                              1 mm                     IPEM (1999)           B
1

2       3.8. CT SIMULATORS


3   CT simulators usually comprise a wide bore CT scanner, together with an external patient
4   positioning and marking mechanism using projected laser lines to indicate the treatment
5   isocentre. This is often termed “virtual simulation”. Since this is an application of CT
6   scanning, there is no international standard. However quality assurance of the scanner and
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 1   alignment system is essential to ensure that the isocentre is accurately located in the
 2   treatment volume for subsequent treatment planning and treatment.                                   The established
 3   standards for CT scanners (see section 2.7) for good image quality and optimum patient
 4   radiation dose apply. Acceptable quality assurance regimes are therefore based upon good
 5   clinical practice. The most recent work is “Quality assurance for computed-tomography
 6   simulators and the computed-tomography-simulation process”: (AAPM, 2003).                                       The
 7   tolerance limits in this report are designed to satisfy the accuracy requirements for
 8   conformal radiotherapy and have been shown to be achievable in a routine clinical setting.
 9   Further guidance is contained in IPEM Report 81 published in 1999. The guidance in Table
10   4.3 is based on these two reports. IPEM Report 81 suggests that the tests are done under
11   the same scanning conditions as those used clinically. Checks on image quality should
12   also be done after software upgrades in case they affect the calibration of the Hounsfield
13   Units. All tests form part of acceptance testing. Where tests are performed routinely for
14   quality control, suggested frequencies of testing are given in AAPM Report 83 (2003), IPEM
15   (1999), CAPCA (2007b) standards and other national QA protocols.

16




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1   Table 4.3 Summary of functional performance characteristics with tolerance/suspension
2   values for acceptance testing and quality control of CT simulators
                  Physical Parameter                       Tolerance/              Reference                 Type
                                                           Suspension             (AAPM,2003)
                                                             Level                unless stated)
     Alignment of CT Gantry Lasers


     With centre of the imaging plane                     ± 2 mm                                        B

     Parallel & orthogonal over length of laser           ± 2 mm                                        B
     projection

     Alignment of Wall Lasers

     Distance to scan plane                               ± 2 mm                                        B

     With imaging plane over length of laser              ± 2 mm               IPEM (1999) 1°           B
     projection

     Alignment of Ceiling Laser

     Orthogonal with imaging plane                        ± 2 mm                                        B

     Orientation of Scanner Table Top

     Orthogonal to imaging plane                          ± 2 mm                                        B

     Scales and Movements

     Readout of longitudinal position of table            ± 1 mm               IPEM (1999) 1 mm         B
     top

     Table top indexing under scanner control             ± 1 mm                                        B

     Readout of gantry tilt accuracy                      ± 1°                                          B

     Gantry tilt position accuracy                        ± 1°                                          B

     Scan Position

     Scan position from pilot images                      ± 1 mm               IPEM (1999) 1 mm         B

     Image Quality

     Left & right registration                            None                 IPEM (1999)              B

     Image scaling                                        2 mm                 IPEM (1999)              B

     CT number/electron density verification              ± 5 HU water                                  B

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                                                           ± 10 HU air
                                                           ± 20 HU lung,
                                                           bone

 1


 2       3.9. COBALT-60 UNITS


 3   IEC 60601-2-11 (2004b) is the standard which identifies those features of design that are
 4   regarded as essential for the safe operation of the equipment and places limits on the
 5   degradation on the performance beyond which a fault condition exists. These include
 6   protection against electrical and mechanical hazards and unwanted and excessive radiation
 7   hazards (i.e. controlling timer, selection and display of treatment related parameters,
 8   leakage radiation and stray radiation). IEC 60601-2-11 (2004b) also includes requirements
 9   for multi-source stereotactic radiotherapy equipment.

10   The IEC has not published performance tolerances for cobalt-60 units.                               The functional
11   performance characteristics and tolerance values in Table 4.4 are based on those for linear
12   accelerators in IEC 60976/7 (2008c, 2007) with some changes for cobalt-60 units. The table
13   does not address multi-source stereotactic radiotherapy equipment.                              There are some
14   differences from recommendations published by national physicists’ associations (IPEM
15   (1999), AAPM (1994) and CAPCA (2006a) standards).                             Where recommendations from
16   these bodies are adopted, they are indicated in the table. For a detailed description of test
17   methods and conditions, please refer to the documents indicated.

18   All tests form part of acceptance testing. Where tests are performed routinely for quality
19   control, suggested frequencies of testing are given in IPEM (1999), AAPM (1994), CAPCA
20   (2006a) standards and other national QA protocols.




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1   Table 4.4 Summary of functional performance characteristics with tolerance/suspension
2   values for acceptance testing and quality control of cobalt-60 units
                Physical Parameter                         Tolerance/                  Reference              Type
                                                        Suspension Level              (IEC (2008c)
                                                                                     unless stated)
     Uniformity of radiation fields
     Beam flatness                                     ±3%                                                A
     Beam symmetry                                     ±2%                        IPEM (1999)             B
     Dependence on gantry and collimator               See IEC 60976/7                                    A
     angle
     Wedge fields
              Maximum deviation of wedge               2%                         IPEM (1999)             B
              factor
              Maximum deviation of wedge               2°                                                 A
              angle
     Source position (when applicable)                 3 mm                       AAPM (1994)             B
     Controlling      Timer   and     Output
     Checks
     Timer check on dual timer difference              1s                         IPEM (1999)             B
     Calibration check                                 2%                                                 A
     Reproducibility                                   0.5 %                                              A
     Proportionality                                   2%                                                 A
     Dependence on gantry rotation                     1%                         IPEM (1999)             B
     Stability in moving beam radiotherapy             See IEC 60976/7            IEC 2007, 2008C,
     Timer linearity                                   1%                         AAPM (1994)             B
     Stability of timer                                ± 0.01 min                                         A
     Output vs field size                              2%                         IPEM (1999)             B
                                                                                  AAPM (1994)
     Shutter correction                                2%                         IPEM (1999)             B
     Depth dose characteristics
     Penetrative quality                               1%                         IPEM (1999)             B
     Depth dose and profile                            2%                         IPEM (1999)             B
     Indication of radiation fields
     Numerical field indication                        3 mm or 1.5 %              IPEM (1999) 2 mm        A, B
     Light field indication                            2 mm or 1 %
     Centres of radiation field and light field        2 mm or 1 %                AAPM (1994) 3           A, B
                                                                                  mm
     Reproducibility                                   2 mm                                               A
     Collimator geometry
              Parallelism of opposing edges            0.5°                                               A
              Orthogonality of adjacent edges          0.5°                                               A
              Beam centring with beam                  2 mm                                               A
              limiting system rotation
     Light field
              Field size (10*10 cm2)                   2 mm                       IPEM (1999)             B

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              Minimum illuminance                      25 lux                                             A

             Minimum edge contrast ratio               4.0                                                A
     Indication of the radiation beam axis
     On entry                                          2 mm                                               A
     On exit                                           3 mm                                               A
     Isocentre
     Radiation beam axis                               2 mm                       IPEM (1999) 1 mm        A, B
                                                                                  AAPM (1994) 2
                                                                                  mm
     Mechanical isocentre                              1 mm                       IPEM (1999)             B
     Indication                                        2 mm                                               A
     Distance indication
     Isocentric equipment                              2 mm                       IPEM (1999) 3 mm        A, B
                                                                                  AAPM (1994) 2
                                                                                  mm
     Non-isocentric equipment                          5 mm                                               A
     Zero position of rotational scales
     Gantry rotation                                   0.5°                       IPEM (1999)             B
     Roll and pitch of radiation head                  0.1°                                               A
     Rotation of beam limiting system                  0.5°                       IPEM (1999)             B
     Isocentric rotation of the patient support        0.5°                                               A
     Table top rotation, pitch and roll                0.5°                                               A
     Accuracy of rotation scales                       1°                         IPEM (1999)             B
     Congruence of opposed radiation                   1 mm                                               A
     fields
     Movements of patient support
     Vertical movements                                2 mm                                               A
     Longitudinal and lateral movements                2 mm                       IPEM (1999)             B
     Isocentric rotation axis                          1 mm                                               A
     Parallelism of rotational axes                    0.5°                                               A
     Longitudinal rigidity                             5 mm                                               A
     Lateral rigidity                                  0.5° and 5 mm                                      A
1

2       3.10. KILOVOLTAGE UNITS


3   IEC 60601-2-8 (1997a) is the standard which identifies those features of design that are
4   regarded as essential for the safe operation of the equipment and places limits on the
5   degradation on the performance beyond which a fault condition exists. These include
6   protection against electrical and mechanical hazards and unwanted and excessive radiation
7   hazards. Tests are based upon IPEM Report 81 (1999), which is based on a survey of UK
8   practice in 1991.         Where recommendations from other bodies are adopted, they are

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 1   indicated in the table. For a detailed description of test methods and conditions, please refer
 2   to the IPEM (1999) and CAPCA (2005d) documents.

 3   All tests form part of acceptance testing. Where tests are performed routinely for quality
 4   control, suggested frequencies of testing are given in IPEM (1999) and the CAPCA (2005d)
 5   standard.

 6


 7   Table 4.5 Summary of functional performance characteristics with tolerance/suspension
 8   values for acceptance testing and quality control of kilovoltage units
                  Physical Parameter                       Tolerance/              Reference                 Type
                                                           Suspension            (IPEM, 1999)
                                                              Level              unless stated)
     Output calibration                                   3%                                 B
     Monitor chamber linearity (if present)               2%                                 B
     Timer end error                                      0.01 min                           B
     Timer accuracy                                       2%                                 B
     Coincidence of light and x-ray beams                 5 mm               CAPCA (2005d) 2 B
                                                                             mm
     Field Uniformity                                     5%                                 B
     HVL constancy                                        10 %                               B
     Measurement of HVL                                   10 %                               B
     Applicator output factors                            3%                                 B
 9

10       3.11. BRACHYTHERAPY


11   IEC 60601-2-17 (2004c) is the standard which identifies those features of design that are
12   regarded as essential for the safe operation of the equipment and places limits on the
13   degradation on the performance beyond which a fault condition exists. These include
14   protection against electrical and mechanical hazards and unwanted and excessive radiation
15   hazards (i.e. controlling timer, selection and display of treatment related parameters and
16   leakage radiation). This safety standard requires in the technical description the statement
17   of tolerances for radioactive source positioning, transit time and dwell time. It also limits the
18   value for the positioning accuracy to 2 mm relative to the specified position.

19   The values given in Table 4.6 are based on the tolerance values in ESTRO Booklet No. 8
20   (2004b), AAPM Report No. 46 (1996) and the CAPCA (2006b) standard.
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 1   All tests form part of acceptance testing. For a detailed description of test methods and
 2   conditions, please refer to the documents above. Where tests are performed routinely for
 3   quality control, suggested frequencies of testing are given in the documents indicated in the
 4   Table.

 5   Table 4.6 Summary of functional performance characteristics with tolerance/suspension
 6   values for acceptance testing and quality control of brachytherapy equipment
                  Physical Parameter                         Tolerance/              Reference                Type
                                                             Suspension           (ESTRO, 2004B)
                                                               Level
     Source calibration
     Single source when only one source used                3%                  AAPM (1994)               B
     (e.g. HDR)
     Individual source in a batch                           5%                                            B
     Mean of batch                                          3%
     (e.g. LDR or permanent implant)

     Linear source uniformity of wire sources               5%                                            B
     Source position                                        2 mm                                          B
     Applicator length                                      1 mm                AAPM (1994)               B
     Controlling timer                                      1%                  AAPM (1994)               B
     Transit time                                           1%                  CAPCA (2006b)             B
 7

 8       3.12. TREATMENT PLANNING SYSTEMS


 9   IEC 62083 (2001b) “Requirements for the safety of radiotherapy treatment planning
10   systems” (RTPS) is the standard which identifies those features of design that are regarded
11   as essential for the safe operation of the equipment. It states that “the output of a RTPS is
12   used by appropriately qualified persons as important information in radiotherapy treatment
13   planning. Inaccuracies in the input data, the limitations of the algorithms, errors in the
14   treatment planning process, or improper use of output data, may represent a safety hazard
15   to patients should the resulting data be used for treatment purposes.” It is principally a
16   software application for medical purposes and is a device that is used to simulate the
17   application of radiation to a patient for a proposed radiotherapy treatment.

18   IAEA-TECDOC-1540 (2007b), addresses specification and acceptance testing of RTPSs,
19   using the IEC 62083 (2001a) document as a basis. This document gives advice on tests to
20   be performed by the manufacturer (type tests) and acceptance tests to be performed at the

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 1   hospital (site tests). IAEA-TECDOC-1583 (2008a) addresses the commissioning of RTPSs.
 2   Both are restricted to photon beam planning, but IMRT is not included. Criteria for the
 3   acceptability of performance tolerances of IMRT plans, e.g. based on gamma calculations,
 4   are an area of development and are not considered in this document. The IEC has not
 5   published performance tolerances for RTPSs, and the tolerances for RTPS for photon
 6   beams in table 4.7 are taken from IAEA-TECDOC-1583 (2008a), where descriptions of test
 7   methods and conditions can also be found.

 8   Table 4.7 Summary of functional performance characteristics with tolerance/suspension
 9   values for acceptance testing and quality control of external beam RTPSs
                           Physical Parameter                                 Tolerance/          Reference      Type
                                                                             Suspension            (IAEA,
                                                                                Level              2008a)
     Output factors at the reference point                                   2%                                 A
     Homogeneous, simple geometry
     Central Axis data of square and rectangular fields                      2%                                 A

     Off-axis data                                                           3%                                 A
     Complex geometry
     Wedged fields, inhomogeneities, irregular fields,                       3%                                 A
     asymmetric collimator setting;
     Central and off-axis data
     Outside beam edges
     In simple geometry                                                      3%                                 A
     In complex geometry                                                     4%                                 A
     Radiological field width 50% - 50% distance                             2 mm                               A
     Beam fringe / penumbra (50% - 90%) distance                             2 mm                               A

10   QA for treatment planning systems is described in IAEA TRS-430 (2004a), AAPM (1998b),
11   ESTRO Booklet No 7 (2007a) for photon beams only and ESTRO Booklet No 8 (2007b) for
12   brachytherapy and the national protocols IPEM (1999) and CAPCA (2007a).

13       3.13. DOSIMETRY EQUIPMENT


14   The quality assurance of dosimetry equipment is considered by AAPM (1994), IPEM (1999)
15   and the CAPCA (2007c) standards. The CAPCA standard is largely based upon AAPM
16   (1994), but with some local measurements.                       IPEM (1999) has the most quantitative
17   measures.       The tests from all reports are set out below in Table 4.8. For a detailed
18   description of test methods and conditions, please refer to these documents. Where tests


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 1   are performed routinely for quality control, suggested frequencies of testing are given in
 2   these documents.

 3   Table 4.8 Summary of functional performance characteristics with tolerance/suspension
 4   values for acceptance testing and quality control of dosimetry equipment
                Physical Parameter                          Tolerance/                       Reference            Type
                                                         Suspension Level                  (IPEM, 1999)
     Ionisation Chambers
     Leakage current                                    0.1 %                       AAPM (1994)                  B
     Linearity                                          0.5 %                       AAPM (1994)                  B
     Radionuclide stability check                       ≤1%
     Calibration against secondary standard             1%
     Beam Data Acquisition Systems
     Positional accuracy                                1mm                         CAPCA (2000c)                B
     Linearity                                          0.5 %                       AAPM (1994)                  B
     Ion recombination losses                           0.5 %                                                    B
     Leakage current                                    0.1 %                       AAPM (1994) 0.5 %            B
     Effect of RF fields                                0.1 %                                                    B
     Stability of compensated signal                    0.2 %                                                    B
     Standard percentage depth dose plot                0.5 %                                                    B
     Constancy of standard percentage depth             0.5 %                                                    B
     dose plot
     Standard profile plot: flatness                    3%                                                       B
     Standard profile plot: field size                  2 mm                                                     B
     Accessories
     Thermometer Calibration                            0.5 deg C                   AAPM (1994) 0.1deg C         B
     Barometer calibration                              1 mbar                                                   B
     Linear rule calibration                            0.3 %                       AAPM (1994)                  B
 5

 6       3.14. RADIOTHERAPY NETWORKS


 7   Modern radiotherapy techniques rely on the transfer of large quantities of data and images
 8   and require reliable data networks for safety and consistency. Quality control largely relates
 9   to checking the correct functionality of processes and safety software, the accuracy of new
10   hardware and software and the comparison of data sets, sent, received or stored. Testing
11   most often occurs with the introduction of new developments.                           Regular testing can be
12   valuable to check for data corruption and hardware faults.

13   The guidance in this section is taken from IPEM Report 93 “Guidance for the
14   Commissioning and Quality Assurance of a Networked Radiotherapy Department” (2006)
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 1   and the parameters needing to be checked routinely are listed in Table 4.9 below. See
 2   IPEM Report 93 (2006) for a full description of the methods for checking these parameters.
 3   Reference can also be made to ISO 17799:2005 “Information Technology – Security
 4   Techniques – Code of Practice for Information Security Management” (2005) for general
 5   advice on information security and national data protection legislation may also be
 6   appropriate.

 7   No suspension levels are given in table 4.9 because functionality must be correct for the
 8   integrity of the data and its transfer. When a loss of functionality is detected, the use of the
 9   network should be suspended until correct functionality is restored.

10   Table 4.9 Operating parameters to be checked routinely
          Operating Parameter
          Review of changes in assets, patch history, data stored, data disclosures, uses of data,
          new or changed equipment and application software
          Check of security fixes for Operating Systems and applications
          Check that anti-virus software is up to date and enabled appropriately
          Monitor logs for unexpected activity
          Monitor availability of security updates and service packs on manufacturer’ websites
          Establish and monitor physical and network boundaries. Look for changes. Check
          physical controls are in place and are effective
          Communication channels
          Dial out: Check that dial-in is not possible after changes in system configuration or system
          upgrades. Check telephone numbers are dialled correctly. Check that assigned
          telephone numbers have not been altered. Check log records for all attempted
          connections, times, dates and endpoints
          Auto answer (dial-in): Check lists of allowed dial-in sources, allowed times and any
          changes in configuration settings, dial-back settings, etc. Check logs are as expected
          All: Monitor link error rates. Check the accuracy of data transmission. Check traffic
          encryption operating. Check for duplicate IP addresses. Monitor traffic for the presence of
          new “unexpected” protocols, promiscuous mode on interfaces or unknown devices
          appearing on the network
          Check physical integrity of cables and terminations. Monitor and document changes in
          physical network configuration. Monitor SNMP traffic logs for significant changes
          DCHP: Monitor changes in the configuration files. Test DNS/DHCP allocation is
          proceeding correctly. Look for new hosts in the lease allocation logs and new additions to
          the network
          Check routing tables are correct for static routes and that routed and gated daemons are
          functional for dynamic routes. Check for propagation of routing information outside
          network boundaries
          Check that firewall rules have not been altered. Check that only allowed hosts, services or
          packets are going through as new devices and applications are added to interior and
          exterior networks. Check firewall log for intrusion signatures
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         Establish which common services are necessary and provide a means of monitoring and
         controlling access to them. Check that all essential services are operational
         Perform security audits of physical location of clients, servers and other critical hardware.
         Review access control measures and administrative personnel lists. Monitor logs for
         console access and machine reboots, looking for discrepancies
         Check logs for remote access and firewall logs for inappropriate clients or protocols
         Examine system logs looking for sessions that are outside expected norms
         Review and update the list of OSs, versions, service packs, applications and patch levels.
         Test applied patches and updates as required in accordance with manufacturer’s
         instructions
         Perform checks for new MAC addresses on the network (DHCP does this automatically).
         Check that unused ports are disabled and/or unpatched. Check that used ports are set to
         fixed MAC addresses where possible
         Check the operation and configuration of the authentication system. Check the signatures
         for the configuration files. Check password change dates are operating as planned.
         Check that back door or manufacturer’s passwords are not enabled or are changed
         regularly
         Monitor accounts added to the system for excessive permissions. Monitor system logs for
         invalid administration log-in attempts
         Transfer test data and checksum. Check for the addition of new fields and data types on
         host systems. For DICOM transfers, use the DICOM ECHO verification service to check
         connectivity and handshaking. For HL7 transfers, check connectivity
         Check backup logs for errors and omissions, and error rates to verify the media is good
         and hardware is not failing. Backup policy must include a retirement age for media.
         Destroy data no longer required. Practice disaster recovery regularly
         Review data flows looking for new cached items. Run reports checking the coherency of
         the data across the system
         Check for the effect of software upgrades, new equipment added, changes in configuration
         and data files. Check the signatures of significant files and update if necessary. Verify
         that the change control process is working
         Perform checks that permissions and shares have not changed from those expected
         Monitor available space, CPU utilisation and use of swap memory on critical devices
         Check NTP client logs for synchronisation failures. Check reference time sources for
         offset and stability. Check that server and client time zone settings have not been
         modified. Check system time against an independent time source
         Check that record locking on files and databases have not been broken after any OS
         changes including service packs, client set-up changes and upgrades
         Data
         Unique identification
         Geometric integrity and scaling
         Region of acceptability of data accuracy and integrity
         Coordinate frame orientation and location
         Patient orientation and specification within the coordinate frame
         Tolerances on images with respect to
                         • pixel values
                         • geometric distortion
1
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 1            APPENDIX 1 INFORMATIVE NOTE ON IMAGING PERFORMANCE


 2   The general purpose of medical imaging is to obtain adequate image quality at the lowest possible
 3   radiation burden to the patient. Assessment of image quality is, therefore, important. Various
 4   methods are available for quantification of image quality (Table DR1.1 based on ICRU Report 54,
 5   1995).


 6   Table A1.1 Assessment of (image) quality at various physical/medical levels
     Approach                                Methods used
     Physical (fundamental) image quality    Large-scale transfer function (characteristic curve),
                                             spatial resolution (transfer function), noise (noise
                                             power spectra)
     Statistical decision theory             Ideal observer formalism, other observers
     Psychophysical approach                 (ROC) analysis, contrast detail method
     Quality assessment using phantoms for a Specific test objects, e.g. for high and low contrast
     specific imaging task                   spatial resolution
     Examination of images of patients       European image quality criteria (diagnostic
                                             radiographic and CT images)
 7
 8   The methods range from those requiring high levels of expertise and facilities (transfer functions),
 9   are very elaborate (ROC analysis) to methods which are in principle applicable in the field in a
10   department of radiology.




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1                        APPENDIX 2 AUTOMATIC EXPOSURE CONTROL


2   Methodology, CR and DDR

3   CR, DDR and AEC

4   The following Tables provide additional information in connection with CR and DDR AEC.
5   They are complementary to the data in Section 2.2 of the text.


6   Table A2.1 Acceptability criteria for the AEC device (CR)
        Physical parameter                 Suspension Level            Reference         Criterion          Notes
        Consistency between               Mean ± 20%                  IPEM                   B           Attenuation
             chambers                                                 (2005a)                             material
           Repeatability                  Mean ± 30%                  IPEM                    B          Attenuation
                                                                      (2005a)                             material
             Consistency                  Mean ± 60%                  IPEM                    B          Attenuation
                                                                      (2005a)                             material
        Image receptor dose                 Speed Class 400:          IPEM                    B          Dosemeter.
                                             > 2.5 µGy± 60%           (2005a)                            1mm-2mm
                                               Speed Class                                               copper filter
                                                   200:
                                          > 5 µGy± 60%

7   Table A2.2 Acceptability criteria for AEC device (DDR)
        Physical parameter                  Suspension              Reference           Criterion          Method
                                              Level
       Consistency between                                         IPEM (2005a)              B            Attenuation
            chambers                                                                                       material
          Repeatability                     Mean ± 30%             IPEM (2005a)              B            Attenuation
                                                                                                           material
             Consistency                    Mean ± 60%             IPEM (2005a)              B            Attenuation
                                                                                                           material
        Image receptor dose                Manufacturers           IPEM (2005a)              B            Dosemeter,
                                           Specification ±                                              1.0mm copper.
                                               60%




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 1                                          APPENDIX 3 EQUIPMENT

 2   Quality Control Equipment for Radiology
 3
 4   Calibration

 5   Instruments should have calibration traceability. Dosimetric instrumentation should comply
 6   with IEC (1997b) and follow international guidelines (IAEA, 2004b). Care should be taken
 7   for measurements in the beam conditions outside of those defined by IEC (1997b) (e.g.
 8   some situations in mammography, computed tomography and interventional radiology and
 9   all situations involving scatter radiation). In these conditions the use of instruments with a
10   small energy response variation is strongly encouraged.                         Field (or clinical) KAP meter
11   calibration should be performed in situ using a calibrated reference instruments using one
12   of two methods as described in IAEA (2007a) and Toroi, Komppa and Kosunen (2008).

13   Some useful equipment

14   Radiographic instrumentation
15       •   Calibrated non invasive tube kVp meter (IAEA, 2007a)
16       •   Dosimeter calibrated in terms of air kerma free-in-air with specialized detectors for
17           measurements in different modalities (ICRU, 2005; IAEA, 2007a).
18       •   Indication of current exposure time product (on the x-ray unit or by ancillary
19           equipment).
20       •   Instrument calibrated for measurement of exposure time.

21   Auxiliary equipment
22     • Accurate tape measure and steel rule
23     • Aluminium filters (type 1100, purity > 99%) ranging from 0.25 mm to 2 mm (HDWA,
24         2000).
25     • Lead rubber sheet(s).
26     • Attenuator set and supports
27     • Radio-opaque grid or equivalent
28     • Collimation and Alignment tools: X-ray field mapping device, e.g. radiographic film,
29         Gafchromic film or equivalent.
30     • Radio-opaque markers – coins or paper clips.
31     • Small lead or copper block
32     • Film Screen Contact Test Tool (Mesh Test Tool).
33     • Non-mercury thermometer, with a range of 25-40 oC and an accuracy of ± 0.1oC.
34     • Geometry test object
35     • High contrast resolution tool (Hüttner 18)

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 1   Phantoms
 2     • Standard CT dose phantoms, Body 32-cm PMMA, Head 16 cm PMMA
 3     • CT uniformity (water) phantoms
 4     • Slice thickness phantom; Inclined planes – axial acquisition, Thin disc or bead
 5     • Measurements to assess the performance of DXA units may have to be performed
 6        using test equipment, some of which is specifically designed for that purpose
 7     • PMMA phantoms of 10, 12, 15, 18 and 20 cm thickness.
 8     • Standard phantom, e.g.: European Spine Phantom [7, 12], BFP [8]

 9   Tomography
10     • Test tool (BIR, 2001; IPEM, 1997b).
11     • Test tool for angle of swing, i.e. a 45º foam pad, pin-hole or other appropriate test
12       tool (IPEM, 1997b)

13   Instrumentation for light and image display
14      • Calibrated Photometer for measuring luminance and illuminance.
15      • Test pattern Image such as SMPTE or T018-QC
16      • Calibrated Sensitometer with 21 steps or pre-exposed sensitometry strips.
17      • Calibrated Densitometer, accuracy of ± 0.01 OD.

18


19




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 1                           REFERENCES & SELECTED BIBLIOGRAPHY

 2

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 6   AAPM (1994) American Association of Physicists in Medicine. Comprehensive QA for Radiation
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 8   AAPM (1995) American Association of Physicists in Medicine. Quantitation of SPECT Performance.
 9   Report No 52. Med. Phys. 22 (4) April.

10   AAPM (1997) American Association of Physicists in Medicine. Code of practice for brachytherapy
11   physics. Report No 59. Med. Phys. 24 (10), 1557-1598.

12   AAPM (1998a) American Association of Physicists in Medicine. High dose-rate brachytherapy
13   treatment delivery. Report No 61. Med. Phys. 25 (4), 375-403.

14   AAPM (1998b) American Association of Physicists in Medicine. Quality assurance for clinical
15   radiotherapy treatment planning. Report No 62. Med. Phys. 25 (10), 1773-1829.

16   AAPM (2002) American Association of Physicists in Medicine. Quality control in diagnostic
17   radiology. Report No 74. July. New York: American Institute of Physics.

18   AAPM (2003) American Association of Physicists in Medicine. Quality assurance of computed-
19   tomography simulators and the computed-tomography-simulation process. Report No 83. Med.
20   Phys. 30 (10), 2762-2792.

21   AAPM (2005) American Association of Physicists in Medicine. Assessment of display performance
22   for     medical    imaging     systems.     Report     OR-03.     [Online]     Available   at
23   http://www.aapm.org/pubs/reports/OR_03.pdf (Accessed: 30 September 2009)

24   AAPM (2006a) American Association of Physicists in Medicine. Acceptance testing and quality
25   control of Photo Stimulable Phosphor Imaging Systems. Report No 93. New York: American
26   Institute of Physics.

27   AAPM (2006b) American Association of Physicists in Medicine. Validating Film Processor
28   Performance. Report No 94. November. College Park, MD: American Association of Physicists in
29   Medicine.

30   Adrian Committee (1960). Radiological Hazards to Patients. Second Report to the Committee.
31   London: Her Majesty’s Stationery Office.

32   AFSSAPS (2007) Agence Française de Sécurité Sanitaire des Produits de Santé. ‘Protocole
33   AFSSAPS CT’, Journal Officiel de la République Française.

34   ARPANSA (2005) Australian Radiation Protection and Nuclear Safety Agency. Code of Practice &
35   Safety Guide. Radiation Protection Series No. 10, December. Australia: Radiation Protection in
36   dentistry.

37   Besluit van het FANC (2008, December 12) Belgian directive: Aanvaardbaarheidscriteria voor
38   röntgenapparatuur voor diagnostisch gebruik in de tandheelkunde.
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 1   BIR (2001) British Institute of Radiology. Assurance of Quality in the Diagnostic X-ray Department.
 2   2nd edn. London: British Institute of Radiology.

 3   BSI (1994) British Standards Institute. BS EN ISO 9002: Quality Systems – Specification for
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 5   Bland, W. F. (1994) ‘CEC suggested technical criteria for radiodiagnostic equipment’. September.

 6   CAPCA (2005a) Canadian Association of Provincial Cancer Agencies. Standards for Quality
 7   Control at Canadian Radiation Treatment Centres, Medical Linear Accelerators. Canada.

 8   CAPCA (2005b) Canadian Association of Provincial Cancer Agencies. Standards for Quality
 9   Control at Canadian Radiation Treatment Centres, Conventional Radiotherapy Simulators. Canada.

10   CAPCA (2005c) Canadian Association of Provincial Cancer Agencies. Standards for Quality
11   Control at Canadian Radiation Treatment Centres, Electronic Portal Imaging Devices. Canada.

12   CAPCA (2005d) Canadian Association of Provincial Cancer Agencies. Standards for Quality
13   Control at Canadian Radiation Treatment Centres, Kilovoltage X-ray Radiotherapy Machines.
14   Canada.

15   CAPCA (2006a) Canadian Association of Provincial Cancer Agencies. Standards for Quality
16   Control at Canadian Radiation Treatment Centres, Cobalt-60 Teletherapy Units. Canada.

17   CAPCA (2006b) Canadian Association of Provincial Cancer Agencies. Standards for Quality
18   Control at Canadian Radiation Treatment Centres, Brachytherapy Remote Afterloaders. Canada.

19   CAPCA (2007a) Canadian Association of Provincial Cancer Agencies. Standards for Quality
20   Control at Canadian Radiation Treatment Centres, Treatment Planning Systems. Canada.

21   CAPCA (2007b) Canadian Association of Provincial Cancer Agencies. Standards for Quality
22   Control at Canadian Radiation Treatment Centres, CT-Simulators. Canada.

23   CAPCA (2007c) Canadian Association of Provincial Cancer Agencies. Standards for Quality
24   Control at Canadian Radiation Treatment Centres, Major Dosimetry Equipment. Canada.

25   CEC (2006) Commission of the European Communities. European guidelines for quality assurance
26   in mammography screening. 4th Edn. Luxembourg: European Commission.

27   Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic
28   safety standards for the health protection of the general public and workers against the dangers of
29   ionizing radiation. OJ L 246, 17.9.1980, p. 1–72.

30   Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the
31   radiation protection of persons undergoing medical examination or treatment. OJ L 265, 5.10.1984,
32   p. 1–3

33   Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ L 169, 12.7.1993, p.
34   1

35   Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the
36   protection of the health of workers and the general public against the dangers arising from ionizing
37   radiation. OJ L 159, 29.6.1996, p. 1–114



                                                                                                         Page 93 of 103
     Radiation Criteria For Acceptability Of Radiological, Nuclear Medicine And Radiotherapy Equipment


 1   Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the
 2   dangers of ionizing radiation in relation to medical exposure, and repealing Directive
 3   84/466/Euratom. OJ L 180, 9.7.1997, p. 22–27

 4   CRCPD (2002) Conference of Radiation Control Program Directors, Inc. CRCPD Publication E-02-
 5   4: Nationwide evaluation of x-ray trends (NEXT) Tabulation and Graphical Summary of 1996
 6   Fluoroscopy Survey. October. Kentucky: Conference of Radiation Control Program Directors, Inc.

 7   Dietzel, G. (2003) ‘Quality Control of PET labelled Agents by TLC, GC and HPLC’. Journal of
 8   Radioanalytical and Nuclear Chemistry, 257, (1), pp. 187-189.

 9   DIN V 6868-58 (2001-01) Image quality assurance in diagnostic X-ray departments - Part 58:
10   Acceptance testing of projection radiography systems with digital image receptors. Berlin: Deutches
11   Institut fur Normung.

12   Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007
13   amending Council Directive 90/385/EEC on the approximation of the laws of the Member States
14   relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical
15   devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with
16   EEA relevance). OJ L 247, 21.9.2007, p. 21–55

17   Directive R-08-05. Contrôle de qualité des installations de radiographie dentaire numérique.May 19,
18   2005. Bundesamt für Gesundheit. Switzerland: Office Fédéral de la santé publique.

19   Dowling, A., Gallagher, A., O’Connor, U., Larkin, A., Gorman, D., Gray, L. and Malone, J.F. (2008)
20   ‘Acceptance testing of fluoroscopy systems’. Radiat Prot Dosimetry: 129 (1-3) p. 291-294.

21   ESTRO Booklet No. 7 (2004a) European Society for Therapeutic Radiology and Oncology. Quality
22   Assurance of Treatment Planning Systems Practical Examples for Non-IMRT Photon Beams.
23   Brussels: ESTRO.

24   ESTRO Booklet No. 8 (2004b) European Society for Therapeutic Radiology and Oncology.
25   European Guidelines for Quality Assurance in Radiotherapy. A Practical Guide to Quality Control of
26   Brachytherapy Equipment. Brussels: ESTRO.

27   European Commission (1996a) Report EUR 16635 EN: The 1991 CEC Trial on Quality Criteria for
28   Diagnostic Radiographic Images: Detailed Results and Findings. Luxembourg: Office for Official
29   Publications of the European Communities.

30   European Commission (1996b) EUR 16260 EN: European Guidelines on Quality Criteria for
31   Diagnostic Radiographic Images. Luxembourg: Office for Official Publications of the European
32   Communities.

33   European Commission (1996c) EUR 16261: European Guidelines on Quality Criteria for Diagnostic
34   Radiographic Images in Paediatrics. Luxembourg: Office for Official Publications of the European
35   Communities.

36   European Commission (1997) Radiation Protection 91: Criteria of acceptability of Radiological
37   (including Radiotherapy) and Nuclear Medicine installations. Luxembourg: Office for Official
38   Publications of the European Communities.

39   European Commission (2004) Radiation Protection 136: European Guidelines on Radiation
40   Protection In Dental Radiology, The Safe Use Of Radiographs In Dental Practice. Luxembourg:
41   Office for Official Publications of the European Communities.


                                                                                                         Page 94 of 103
     Radiation Criteria For Acceptability Of Radiological, Nuclear Medicine And Radiotherapy Equipment


 1   Gallagher, A., Dowling, A., Devine, M., Bosmans, H., Kaplanis, P., Zdesar, U., Vassileva, J., &
 2   Malone, J. F. (2008). ‘European Survey of Dental X-Ray Equipment’. Radiat Prot Dosimetry: 129 p.
 3   284-287.

 4   Genant, H.K., Grampp, S., Glüer, C.C., Faulkner, K.G., Jergas, M., Engelke, K., and Hagiwara, S.,
 5   Van Kuijk, C. (1994) ‘Universal standardization for dual x-ray absorptiometry: patient and phantom
 6   cross-calibration results’. J Bone Miner Res: 9 (10) p. 1503-14

 7   Greenfield, J.R., Samaras, K., Chisholm, D.J., and Campbell, L.V. (2002) ‘Regional intra-subject
 8   variability in abdominal adiposity limits usefulness of computed tomography’. Obes Res: 10 (4) p.
 9   260-5.

10   Guidance Notes for Dental Practitioners on the Safe Use of X-ray Equipment. (2001). UK: National
11   Radiological Protection Board and Department of Health.

12   Halkar, R. K., and Aarsvold, J. N. (1999) ‘Intraoperative Probes’. Journal of Nuclear Medicine
13   Technology: 27 (3) September p. 188-192.

14   Halpern, E.J. (1995) ‘A test pattern for quality control of laser scanner and CCD film digitizers’. J.D.
15   Imaging: 8: 3-9.

16   HDWA (2000) Health Department of Western Australia. Radiation safety act 1976, diagnostic x-ray
17   compliance testing. Australia: Program Requirements.

18   IAEA (1994) International Atomic Energy Agency. IAEA Technical Report Series 374: Calibration of
19   Dosimeters used in Radiotherapy. Vienna: International Atomic Energy Agency.

20   IAEA (1996) International Atomic Energy Agency. IAEA Safety Series 115: International Basic
21   Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources.
22   Vienna: International Atomic Energy Agency.

23   IAEA (2000) International Atomic Energy Agency. IAEA Safety Reports Series No. 16: Calibration of
24   Radiation Protection Monitoring Instruments. Vienna: International Atomic Energy Agency.

25   IAEA (2004a) International Atomic Energy Agency. IAEA Report TRS-430: Commissioning and
26   Quality Assurance of Computerized Planning Systems for Radiation Treatment of Cancer. Vienna:
27   International Atomic Energy Agency.

28   IAEA (2004b) International Atomic Energy Agency. IAEA Technical Reports Series No. 457:
29   Dosimetry in Diagnostic Radiology: An International Code of Practice. Vienna: International Atomic
30   Energy Agency.

31   IAEA (2006) International Atomic Energy Agency. IAEA Technical Report Series No. 454: Quality
32   Assurance of Radioactivity Measurements in Nuclear Medicine. STI/DOC/010/454. Vienna:
33   International Atomic Energy Agency.

34   IAEA (2007a) International Atomic Energy Agency. IAEA Technical Report Series No. 457:
35   Dosimetry in Diagnostic Radiology: An International Code of Practice. STI/DOC/010/457. Vienna:
36   International Atomic Energy Agency.

37   IAEA (2007b) International Atomic Energy Agency. IAEA-TECDOC-1540: Specification and
38   Acceptance testing of Radiotherapy Treatment Planning Systems. Vienna: International Atomic
39   Energy Agency.

40   IAEA (2007c) International Atomic Energy Agency. IAEA-TECDOC: Quality Control of SPECT
41   Systems.2007 edn. Vienna: International Atomic Energy Agency.
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     Radiation Criteria For Acceptability Of Radiological, Nuclear Medicine And Radiotherapy Equipment


 1   IAEA (2008a) International Atomic Energy Agency. IAEA-TECDOC-1583: Commissioning of
 2   Radiotherapy Treatment Planning Systems: Testing for Typical External Beam Treatment
 3   Techniques. Vienna: International Atomic Energy Agency.

 4   IAEA (2008b) International Atomic Energy Agency. Guidelines for the use of DXA in measuring
 5   bone density and soft tissue body composition: A Handbook Rep. TBA. Vienna: International Atomic
 6   Energy Agency.

 7    IAEA (2009) International Atomic Energy Agency. Human Health Series No. 1: Quality Assurance
 8   for PET and PET/CT Systems. Vienna: International Atomic Energy Agency.

 9   ICRP (1991) International Commission on Radiological Protection. Publication 60: 1990
10   Recommendations of the International Commission on Radiological Protection. Annals of the ICRP
11   21 (1-3). Oxford: Pergamon Press.

12   ICRP (1996) International Commission on Radiological Protection. Publication 73: Radiological
13   Protection and Safety in Medicine. Annals of the ICRP 26 (2). Oxford: Pergamon Press.

14   ICRU (1992) International Commission on Radiation Units and Measurements. Measurement of
15   Dose Equivalents from External Photon and Electron Radiations (Report 47). Bethesda:
16   International Commission on Radiation Units and Measurements.

17   ICRU (1995) International Commission on Radiation Units and Measurements. Medical Imaging -
18   The Assessment of Image Quality (Report 54). Bethesda: International Commission on Radiation
19   Units and Measurements.

20   ICRU (2005) International Commission on Radiation Units and Measurements. Patient Dosimetry
21   for X-Rays Used in Medical Imaging (Report 74). Journal of the ICRU: 5 (2). Bethesda: International
22   Commission on Radiation Units and Measurements.

23   IEC (1993a) International Electrotechnical Commission. IEC 61168 Ed.1.0: Radiotherapy simulators
24   – Functional performance characteristics. Geneva: IEC.

25   IEC (1993b) International Electrotechnical Commission. IEC 61170 Ed 1.0: Radiotherapy simulators
26   – Guidelines for functional performance characteristics. Geneva: IEC.

27   IEC (1993c) International Electrotechnical Commission. IEC/TS 61223-2-1 Ed 1.0: Evaluation and
28   routing testing in medical imaging departments - Part 2-1: Constancy tests - Film processors.
29   Geneva: IEC.

30   IEC (1993d) International Electrotechnical Commission. IEC/TS 61223-2-2: Evaluation and routing
31   testing in medical imaging departments - Part 2-2: Constancy tests - Radiographic Cassettes and
32   Film changers, Film Screen Contact and relative sensitivity of the screen cassette assembly.
33   Geneva: IEC.

34   IEC (1993e) International Electrotechnical Commission. IEC/TS 61223-2-3: Evaluation and routing
35   testing in medical imaging departments - Part 2-3: Constancy tests - Darkroom Safelight Conditions.
36   Geneva: IEC.

37   IEC (1993f) International Electrotechnical Commission. IEC/TS 61223-2-12: Evaluation and routing
38   testing in medical imaging departments - Part 2-3: Constancy tests - Film Illuminators. Geneva: IEC.

39   IEC (1994a) International Electrotechnical Commission. IEC 61223-2-4 Ed 1.0: Evaluation and
40   routine testing in medical imaging departments - Part 2-4: Constancy Tests - Hard copy cameras.
41   Geneva: IEC.

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 1   IEC (1994b) International Electrotechnical Commission. IEC 61223-2-5 Ed 1.0: Evaluation and
 2   routine testing in medical imaging departments - Part 2-5: Constancy Tests - Image display devices.
 3   Geneva: IEC.

 4   IEC (1994c) International Electrotechnical Commission. IEC 61303 Ed 1.0: Medical electrical
 5   equipment – Radionuclide calibrators – Particular methods for describing performance. Geneva:
 6   IEC.]

 7   IEC (1997a) International Electrotechnical Commission. IEC 60601-2-8 Ed 1.0: Medical electrical
 8   equipment – Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment
 9   operating in the range 10kV to 1MV. Geneva: IEC.

10   IEC (1997b) International Electrotechnical Commission. IEC-61674 Ed 1.0: Medical Electrical
11   Equipment - Dosimeters with Ionization Chambers and/or Semi-conductor Detectors as used in X-
12   Ray Diagnostic Imaging. Geneva: IEC.

13   IEC (1998a) International Electrotechnical Commission. IEC 60601-2-1 Ed 2.0: Medical electrical
14   equipment – Part 2-1: Particular requirements for the safety of electron accelerators in the range 1
15   MeV to 50 MeV. Geneva: IEC.

16   IEC (1998b) International Electrotechnical Commission. IEC 61675-2 Ed 1.0: Radionuclide Imaging
17   Devices – Characteristics and Test Conditions – Part 2: Single Photon emission computed
18   tomographs. Geneva: IEC.

19   IEC (1998c) International Electrotechnical Commission. IEC 61675-3 Ed 1.0: Radionuclide Imaging
20   Devices – Characteristics and test Conditions – Part 3: Gamma Camera based whole body imaging
21   systems. Geneva: IEC.

22   IEC (1999) International Electrotechnical Commission. IEC 60522 Ed 2.0: Determination of the
23   permanent filtration of X-ray tube assemblies. Geneva: IEC.

24   IEC (2000a) International Electrotechnical Commission. IEC 61223-3-4 Ed 2.0: Evaluation and
25   routine testing in medical imaging departments – Part 3.4: Acceptance tests – Imaging performance
26   of dental X-ray equipment. Geneva: IEC.

27   IEC (2000b) International Electrotechnical Commission. IEC 60601-2-43 Ed 1.0: Medical Electrical
28   Equipment. Part 2-43: Particular Requirements for Safety of x-Ray Equipment for interventional
29   Procedures. Geneva: IEC.

30   IEC (2001a) International Electrotechnical Commission. IEC TR 61948-1 Ed 1.0: Nuclear medicine
31   instrumentation – Routine tests – Part 1: Radiation counting systems. Geneva: IEC.

32   IEC (2001b) International Electrotechnical Commission. IEC 62083: Medical electrical equipment –
33   Requirements for the safety of radiotherapy treatment planning systems. Geneva: IEC.

34   IEC (2003a) International Electrotechnical Commission. IEC 60336: Medical electrical equipment –
35   x-ray tube assemblies for medical diagnosis: Characteristics of focal spot sizes. Geneva: IEC.

36   IEC (2003b) International Electrotechnical Commission. IEC 60601-1: Medical electrical equipment
37   – Part 1: General requirements for basic safety and essential performance. Geneva: IEC.

38   IEC (2004a) International Electrotechnical Commission. IEC 61223-3-5 Ed 1.0: Evaluation and
39   Routine Testing in Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging
40   Performance of Computed Tomography X-ray Equipment. Geneva: IEC.


                                                                                                         Page 97 of 103
     Radiation Criteria For Acceptability Of Radiological, Nuclear Medicine And Radiotherapy Equipment


 1   IEC (2004b) International Electrotechnical Commission. IEC 60601-2-11-am1 Ed 2.0: Amendment 1
 2   - Medical electrical equipment – Part 2-11: Particular requirements for the safety of gamma beam
 3   therapy equipment. Geneva: IEC.

 4   IEC (2004c) International Electrotechnical Commission. IEC 60601-2-17 Ed 2.0: Medical electrical
 5   equipment – Part 2-17: Particular requirements for the safety of automatically-controlled
 6   brachytherapy afterloading equipment. Geneva: IEC.

 7   IEC (2004d) International Electrotechnical Commission. IEC 61675-2-am1 Ed 1.0: Radionuclide
 8   Imaging Devices – Characteristics and Test Conditions – Part 2: Single Photon emission computed
 9   tomographs. Geneva: IEC.

10   IEC (2005a) International Electrotechnical Commission. IEC 60789 Ed 3.0: Medical Electrical
11   Equipment – Characteristics and Test Conditions of Radionuclide Imaging Devices – Anger Type
12   Gamma Cameras. Geneva: IEC.

13   IEC (2005b) International Electrotechnical Commission. IEC TR 61948-3 Ed 1.0: Nuclear medicine
14   instrumentation – Routine tests – Part 3: Positron emission tomographs. Geneva: IEC.

15   IEC (2006) International Electrotechnical Commission. IEC TR 61948-4 Ed 1.0: Nuclear medicine
16   instrumentation – Routine tests – Part 4: Radionuclide calibrators. Geneva: IEC.

17   IEC (2007) International Electrotechnical Commission. IEC 60976 Ed 2.0: Medical electrical
18   equipment – Medical electron accelerators - Functional performance characteristics. Geneva: IEC.

19   IEC (2008a) International Electrotechnical Commission. IEC 60601-1-3: Medical electrical
20   equipment – Part 1-3: General requirements for basic safety and essential performance – collateral
21   standard. Radiation protection in diagnostic x-ray equipment. Geneva: IEC.

22   IEC (2008b) International Electrotechnical Commission. IEC 60601-2-29 Ed 3.0: Medical electrical
23   equipment – Part 2-29: Particular requirements for the basic safety and essential performance of
24   radiotherapy simulators. Geneva: IEC.

25   IEC (200c) International Electrotechnical Commission. IEC 60977 Ed 2.0: Medical electrical
26   equipment – Medical electron accelerators - Guidelines for functional performance characteristics.
27   Geneva: IEC.

28   IEC (2008d) International Electrotechnical Commission. IEC 61675-1 Ed 1.1: Radionuclide Imaging
29   Devices – Characteristics and test conditions – Part 1: Positron emission Tomography. Geneva:
30   IEC.

31   IEC (2009) International Electrotechnical Commission. IEC 60846-1: Radiation Protection
32   Instrumentation – Ambient and/or directional dose equivalent (rate) meters and/or monitors for beta,
33   X and gamma radiation – Part 1: Portable work place and environmental meters and monitors.
34   Geneva: IEC.

35   IEMA (2004) Institute of Environmental Management and Assessment. BS EN 60846:2004:
36   Radiation protection Instrumentation – Ambient and/or directional dose equivalent (rate) meters
37   and/or monitors for beta, X and gamma radiation. Lincoln: IEMA.

38   IMPACT (2000) Comparison of the imaging performance of CT scanners. Issue 12 (MDA/00/11).
39   London: Department of Health.

40   IPEM (1997a) Institute of Physicists and Engineers in Medicine. Measurement of the Performance
41   Characteristics of Diagnostic X-ray Systems used in Medicine, Report 32, 2nd edn, Part IV: X-ray

                                                                                                         Page 98 of 103
     Radiation Criteria For Acceptability Of Radiological, Nuclear Medicine And Radiotherapy Equipment


 1   Intensifying Screens, Films, Processors and Automatic Exposure Control Systems. York: Institute of
 2   Physicists and Engineers in Medicine.

 3   IPEM (1997b) Institute of Physics and Engineering in Medicine. Measurement of the performance
 4   characteristics of Diagnostic X-Ray Systems used in Medicine, Report 32, 2nd edn, Part V:
 5   Conventional Tomography Equipment. York: Institute of Physics and Engineering in Medicine.

 6   IPEM (1997c) Institute of Physics and Engineering in Medicine. Recommended Standards for the
 7   Routine Performance Testing of Diagnostic X-ray Imaging Systems, Report 77. York: Institute of
 8   Physicists and Engineers in Medicine.

 9   IPEM (1999) Institute of Physics and Engineering in Medicine. Physical Aspects of Quality Control in
10   Radiotherapy, Report 81. York: Institute of Physics and Engineering in Medicine.

11   IPEM (2002) Institute of Physicists and Engineers in Medicine. Medical and Dental Guidance Notes,
12   A good practice guide on all aspects of ionising radiation protection in the clinical environment. York:
13   Institute of Physicists and Engineers in Medicine.

14   IPEM (2003a) Institute of Physicists and Engineers in Medicine. Measurement of the Performance
15   Characteristics of Diagnostic X-ray Systems used in Medicine, Report 32, 2nd edn, Part III:
16   Computed Tomography X-ray Scanners. York: Institute of Physicists and Engineers in Medicine.

17   IPEM (2003b) Institute of Physics and Engineering in Medicine Quality Assurance in Gamma
18   Camera Systems, Report 86. York: Institute of Physicists and Engineers in Medicine.

19   IPEM (2005a) Institute of Physicists and Engineers in Medicine. Recommended Standards for the
20   Routine Performance Testing of Diagnostic X-Ray Imaging Systems, Report 91. York: Institute of
21   Physicists and Engineers in Medicine.

22   IPEM (2005b) Institute of Physicists and Engineers in Medicine. Commissioning and Routing
23   Testing Of Mammographic X-Ray Systems, Report 89. York: Institute of Physicists and Engineers in
24   Medicine.

25   IPEM (2006) Institute of Physics and Engineering in Medicine. Guidance for the Commissioning and
26   Quality Assurance of a Networked Radiotherapy Department, Report 93. York: Institute of Physics
27   and Engineering in Medicine.

28   IPEM (2008) Institute of Physicists and Engineers in Medicine. Quality Assurance in Dental
29   Radiology, Report 67. York: Institute of Physics and Engineering in Medicine.

30   IPSM, NRPB and CoR (1992) Institute of Physical Sciences in Medicine, National Radiological
31   Protection Board and Royal College of Radiographers. National Protocol for Patient Dose
32   Measurements in Diagnostic Radiology. Chilton: National Radiological Protection Board.

33   IPSM (1994) Institute of Physical Sciences in Medicine. Recommendations for the Presentation of
34   Type test Data for Radiation Protection Instruments in Hospitals, Report 69. IPSM.

35   ISO/IEC (2005) International Organisation for Standardization and International Electrotechnical
36   Commission. ISO/IEC 17799:2005, Information technology – Security techniques – Code of practice
37   for information security management. Geneva: ISO.

38   ISO, IEC, OIML and BIPM (1992) International Organization for Standardization, International
39   Electrotechnical Commission, International Organization of Legal Metrology and International
40   Bureau of Weights and Measures. Guide to the Expression of Uncertainty in Measurement. 1st edn.
41   Geneva: ISO.

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 1   Jones, D.G. and Wall, B.F. (1985) Organ Doses from Medical X-Ray Examinations Calculated
 2   Using Monte Carlo Techniques. NRPB-R186. London: Her Majesty’s Stationery Office.

 3   JORF (2007) Journal Officiel de la République Française. Texte 33 sur 123. October 25.

 4   JORF 0300 (26 December), (79) p. 20066.

 5   Kal, H. B. and Zoetelief, J. (1995) Criteria for acceptability of radiobiological and nuclear medicine
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 7   Kalender, W.A. (2000) Computed Tomography: Fundamentals, System Technology, Image Quality,
 8   Applications. Munich: Publicis MCD Verlag.

 9   Kalender, W. A., Felsenberg, D., Genant, H. K., Fischer, M., Dequeker, J. and Reeve, J. (1995) ‘The
10   European Spine Phantom--a tool for standardization and quality control in spinal bone mineral
11   measurements by DXA and QCT’. Eur J Radiol: 20 (2) p. 83-92.

12   Kelly, T.L., Slovik, D.M., and Neer, R.M., (1989) ‘Calibration and standardization of bone mineral
13   densitometers’. J Bone Miner Res: 4 (5) p. 663-9.

14   KCARE (2005a) King’s Centre for the Assessment of Radiological Equipment. Protocol for the QA
15   of Computed Radiography Systems, Commissioning and Annual QA Tests. London: KCare.

16   KCARE (2005b) King’s Centre for the Assessment of Radiological Equipment. Protocol for the QA
17   of Direct Digital Radiography Systems Commissioning and Annual QA Tests. London: KCare.

18   Larkin, A., Sheahan, N., O'Connor, U., Gray, L., Dowling, A., Vano, E., Torbica, P., Salat, D.,
19   Schreiner, A., Neofotistou, V., and Malone, J.F. (2008) ‘QA/Acceptance Testing of DEXA X-Ray
20   Systems Used in Bone Mineral Densitometry’. Radiat Prot Dosimetry: 129 (1-3) p. 279 – 283.

21   Lim, A.J. (1996) Image quality in films digitizers: testing and quality assurance. RSNA Categorical
22   Course in Physics, p. 183-193.

23   Luxembourg Annexe 7 (2008) 10.01.08

24   Martin, C.J., Sutton, D.G., Workman, A., Shaw, A.J. and Temperton, D. (1998) ‘Protocol for
25   measurement of surface dose rates for fluoroscopic x-ray equipment’. Brit J Radiol: 71 (852) p.
26   1283-1287.

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28   Medical Physics 22 (5) May p. 635-642.

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34

35




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                                        ACKNOWLEDGEMENTS



    Coordinator: Dr Keith Faulkner
    Diagnostic Radiology Lead: Prof Jim Malone
    Nuclear Medicine Lead: Dr Stelios Christofides
    Radiotherapy Lead: Prof Stephen Lillicrap


    Contributors                                                    Reviewers


    Diagnostic Radiology                                                Dr Tamas Porubszky
        Dr Steve Balter                                                 Mr S. Szekeres
        Dr Norbert Bischof                                              Markku Tapiovaara
        Dr Hilde Bosmans                                                Kalle Kepler
        Ms Anita Dowling                                                Koos Geleijns
        Aoife Gallagher                                                 Simon Thomas PhD FIPEM
        Remy Klausz                                                     Geraldine O’Reilly
        Dr Lesley Malone
        Ian (Donald) Mclean
        Dr Alexandra Schreiner
        Dr Eliseo Vano
        Colin Walsh
        Dr Hans Zoetelief


    Nuclear Medicine
        Dr Inger-Lena Lamm
        Dr Soren Mattsson


    Radiotherapy
        Prof Patrick Horton
        Dr Inger-Lena Lamm
        Dr Wolfgang Lehmann



                                                                                                    Page 103 of 103

								
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