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NARK-DKE-ISO Participants’ Meeting Report mt-pq-ism/dr.cfw-mö
33rd ISO TC 121Anaesthetic and Respiratory Equipment ISM 2004-30
Milano / 14-18 June 2004 29 June 2004
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Participants NBM/062/04
55 delegates from AU, BE, CA, DE, DK, FI, FR, IT, JA, NZ0, SE, SP, UK, US
__________________________________________________________________________________________
Distribution
NARK 3.1, 3.2, 3.3, 3.6 via
Ms Dr. V. Sattelmayer, DIN
K 810, K 812, K 812.3 & K 812.8 via
Dr. K. Neuder, DKE
EUROM VI / SPECTARIS members via
Mr. M. Wenzel, SPECTARIS
EUROM VI WG2 members via
Mr. H. Cooke, BAREMA
CENELEC TC 62 members via
Mr. C. Duncombe, BSI
ZVEI TK/FK members via
Ms. M. Vedder, ZVEI
COCIR TC members via
Mr. G. Strattner, COCIR
DGAI TK members via
Prof. P. Schmucker, DGAI
CEN TC 215 WG1 members via
Ms Dr. V. Sattelmayer, DIN
__________________________________________________________________________________________
Address
Ente Nazionale Italiano di Unificazione - UNI
Via Battistotti Sassi 11/b
I-20133 Milano
Tel. 39-02-70024-464
Fax +39-02-70024-474
__________________________________________________________________________________________
Place / Date
Milano / 14-18 June 2004
__________________________________________________________________________________________
Subject
33rd ISO TC 121, SC1, SC1 WG9, SC3, SC6 Meeting
__________________________________________________________________________________________
ISO TC 121 and its subcommittees and working groups hold its 33rd annual meeting in Milano with the
following results:
I. ISO TC 121 Anaesthetic and respiratory equipment
Chair: Dr. Ronny Greenbaum, UK
Secretary: Mr. David Upstone, UK
Participants: 48/36 delegates from AU, CA, DE, DK, FI, FR, IT, JA, SE, UK, US
Place/Date: Milano / 14 and 18 June 2004
I.1 NWIP - resubmitted
NWIP on anaesthetic systems for emergency and remote area application WHO letter from Dr. Groth
was received last week by the TC 121 chair and secretary, the latter responded with the statistics about
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NARK-DKE-ISO Participants’ Meeting Report mt-pq-ism/dr.cfw-mö
33rd ISO TC 121Anaesthetic and Respiratory Equipment ISM 2004-30
Milano / 14-18 June 2004 29 June 2004
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the ballot were 13 countries did not respond and from the responding countries not sufficient members
indicated willingness to participate. Issue to be addressed by SC1.
US NWIPs on blood and fluid warmers and patient warmers did not receive sufficient participation
either. Again 13 countries did not respond including the submitting US. There appears to be a problem
with life link access.
Topics to be revisited at the second plenary.
I.2 SC4 terminology
Dr. Jerry Dorsch plans to resign as chairman as long as TC 121 is meeting in June because of work
conflicts.
I.3 Proposal for joint ISO TC 121 - IEC TC 62 work
In 2003 CLC asked CEN to stop work on RGM, anaesthetic workstations, ventilators; topic was
deferred. IEC TC 62 in October 2003 set up TC 62E for joint ISO IEC work. ISO ad-hoc group met
around Eastern 2004, CEN TC 215 discussed issue at April 30, 2004 Malta meeting; only conclusion
that no conclusion.
Options: do nothing; some JWGs with editorial problems between ISO and IEC which seem to
disappear, especially with 3rd edition; fully joint subcommittee ISO CS is not very enthusiastic, only
JSC on software with mostly ISO participants; N 744 Mike Smith proposal to use 80000 concept to be
transferred to IEC 60601 series written under ISO or IEC lead; issue of work division, suggestion from
DE members body as used between DIN/F&O and DKE/ZVEI: electricity to drive the device is ISO,
where electricity is applied directly or indirectly to the patient is IEC. If no decision is mode decision
might be put upon us. SC6 and SC2 appear not to be affected.
SC1 split 50:50, SC3 split 80:20, SC8 66:33
ISO withdrew ISO versions of AWS and ventilators.
IEC TC 62E modus operandi is put on hold until this group has made a decision. Did the split of work
work in Germany: yes since the 1970s with about 90 to 95% allocated to ISO and 5% to IEC; national
mirror groups of ISO and IEC have been meeting together since 1990 and formed formal JWG last year.
DE proposal also request that splitting of series i.e. ventilators and anaesthesia workstation be undone
and put under one leadership.
Historically IEC seemed to win when there was a conflict between ISO and IEC.
ISO has more clinicians participating.
More and more work has been hijacked by IEC without credit to ISO.
Brighton 1989 agreement between IEC and ISO about cooperation appears to be only having been
between individuals in form of a gentlemen agreement. IEC 80000 series appear to be most balanced
proposal with a limited numbers of joint working groups, ISO led groups can meet where the convenor
likes to meet. However joint SC meetings allow coordination and should not be disburdened.
ISO, IEC, CEN, CLC should be merged into one organization as ultimate
CAG to act as drafting committee. Clear policy needed.
US TAG supports mode 5 operation, odd number of people for advisory group.
CAG to receive proposals by SCs by Tuesday night June 15, 2004.
CLC NWIP: US to explain why suitable for ISO TC 121or wait for CAG output generic controller of
physiological function: IEC per view of the chair.
J.G.: for anaesthetic and ventilation main focus but should be written broadly, e.g. blood pressure
titration. Concern of clinical input e.g. cerebral function, raised by N.N. Modelling of physiology is
required at some stage, also for et CO2; SC3 to further elaborate.
Revisited 18 June 2004: D.U. got negative feedback from Mike Smith about IEC on joint SC.
N45 summarizes 9 conclusions prepared by CAG.
DE proposed to amend, seconded by UK and JA.
6) …. agreed criteria, e.g. the examples offered by DIN in which allocation is determined by whether
electricity is supplied to the patient (IEC) or used to power the device (ISO).
Added: Standards series should be allocated to the same leadership. - carried unanimously.
9) Model(s) for the structure …. on the proposals prepared by SC3 N46 centered around a joint
subcommittee ….
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33rd ISO TC 121Anaesthetic and Respiratory Equipment ISM 2004-30
Milano / 14-18 June 2004 29 June 2004
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DE motion to delete, seconded by US: DE, UK, CA, IT, AU, FI, JA, US, DK (9) - carried.
abstain SE (1)
Face to face negotiation: DE, SC1 and SC3 chairmen should participate per J.H.-W.
TC 121, SC1, SC2, SC3 chair plus secretary + C.F.W., DE + M.G., US = 9
NWIP blood warmers
Accepted on the basis that US is counted as positive vote in spite of not voting life link access on
last three NWIP blood warmers, patient warmers and emergency and remote area application to be
evaluated by D.U. per DE request if data are still logged.
NWIP physiological closed loop controller
SC3 proposes SC1/SC3 - IEC TC 62A JWG
SC1 proposes SC1 - IEC 62A
D.U. proposes TC 121 - IEC 62A - IEC lead
ISO NWIP pro: DE, JA, AU, CA, FI, US, DK, SE, UK (9) - revised + IT (10)
against: IT (1) - revised (0)
IT: IEC to drive the NWIP - which is planned, consequently
IT changed to positive vote after J.G. interrogation.
C.J.: SC1 happy to take the lead being short of work items.
NO is in SC3, not in SC1 and TC 121.
South Africa is in SC1, not in SC3 and TC 121.
SNOWMED
APSF work through SNOWMED taxometry. J.G. proposal to contact Dr. Steven Dain, anaesthesia
patient dictionary requires a li….??
systematic nomenclature …. medicine
GMDN mentioned by C.F.W.
Liaison
CEN TC 215: report N 736 noted for 9 Feb. 2004, updates after Malta 30 April 2004 meeting.
ISO 58 gas cylinder
Nothing of significance per D.P. ISO 5145 issued, FDIS 407 essentially unchanged.
SC1 anaesthetic equipment
NWIP to amend ISO 5360:1995 agent specific filling systems to be revised with CEN as a revision
of EN 1280-1 under Vienna Agreement VA with ISO lead.
ISO CD 8835-2 breathing systems to be issued for CD ballot and comment.
ISO DIS 8835-3 AGSS to be issued for DIS ballot and comment. Concern by D.P. about proper
interface with EN 737-2 / ISO 7696-2 AGS disposal systems being revised under VA with CEN
lead. C.F.W. being a member of SC1, SC6, CEN WG3 will make sure that the John Dunn interface
performance criteria is being honoured as long as C.F.W. is around.
D.K. is ISO SC6 project follower to WG3.
NWIP physiological closed loop controller - see above.
SC2 breathing tubes etc.
ISO 11990 laser and related equipment - joint ISO TC 172 WG9 and TC 121 SC2 revision
considered.
ISO TR 16628 marking and labelling of endobronchial tubes to develop into a standard under VA.
NWIP laryngoscopes for tracheal intubation - illumination accepted.
NWIP colour coding of venturi masks - JA to propose.
ISO 5362 tracheal tubes - systematic review, request to change the free end of inflating tube from
luer to non luer connector rejected, 8.5 mm connector rejected, to harmonize with EN 1782
rejected.
CEN BT TF 123 is submitting 5th CD with the intend to move away from luers.
ISO 7376 laryngoscope for tracheal intubation - to merge with NWIP single use laryngoscopes
from AU.
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33rd ISO TC 121Anaesthetic and Respiratory Equipment ISM 2004-30
Milano / 14-18 June 2004 29 June 2004
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SC3 respiratory equipment
ISO FDIS 9919 pulse oximeter submittal for formal vote.
NWIP physiological closed loop controller - see above.
J.H.-W. reconfirmed as convenor for another three years without punitive damages.
JWG medicinal products inhaler and catheters: J.H.-W., Lauren Ziegler, Dirk von Hollen appointed
as liaison and experts to JWG formed between TC 84 WG5, TC 76 and TC 121 SC3.
ISO DIS 10651-5 gas powered emergency resuscitators to be submitted for ballot and comment.
ISO CD2 17510-1 sleep apnoea breathing therapy equipment to be submitted for comment.
SC6 medical gas pipelines
ISO DIS 10083 oxygen concentrator supply systems for use with medical gas pipeline systems to
be submitted for ballot and comment.
Dr. Klaus Züchner nominated as project follower.
ISO FDIS 19054 rail systems submittal for formal vote.
NWIP ISO 10524-4 to exclude pressure regulators within medical devices.
ISO 9170-1:1999 / EN 737-1:1997 terminal units joint VA revision ISO lead.
ISO 9170-2:…. / EN 737-4:1997 AGS terminal units joint VA revision ISO lead.
ISO 15002:2000 / EN 13220:1999 flow metering devices for connection to terminal units
joint VA revision ISO lead.
ISO 7396-2:2000 / EN 737-2:1998 + Amd.1:2000 AGS disposal systems joint VA revision CEN
lead with Derek Kirby as ISO project follower.
David S. Sheridan †
He passed away age 95, J.H.-W. and Tessa went to his funeral, J.G. remembered him from ASA
technical exhibit, letter of condolence to be sent by D.U. to his widow. D.S.S. made various
contributions to fire departments, churches, universities.
Next meetings
13 to 17 June 2005 Lübeck
05 to 09 June 2006 Helsinki
signed signed signed signed
Dr. Carl F. Wallroth Dr. Dieter Weismann Hubertus Lasthaus Dr. Klaus Züchner
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33rd ISO TC 121Anaesthetic and Respiratory Equipment ISM 2004-30
Milano / 14-18 June 2004 29 June 2004
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II. ISO TC 121 SC1 Anaesthetic equipment
Chair: Dr. Christopher Joseph, AU acting for Dr. Ian de Jersey, AU
Secretary: Mr. David Upstone, UK
Participants: 13 members from AU, CA, DE, JA, UK, US
Place / Date: Milano / 16 and 17 June 2004
II.1 Proposal for joint ISO TC 121 - IEC 62 work
The following criteria were identified for the CAG meeting 15 June 2004 -17:00 h deliberation:
- formal cooperation with IEC under mode 5
- ongoing work allocation to continue until completion
- future allocation under German criteria
- ISO TC 121/SC/mode 5 JWG meeting structure to continue
- use N 744 proposal as basis which brings ventilator and anaesthetic workstation series back to
ISO.
II.2 AGSS for weaning patients and for filling vaporizers
Alfredo Galassini, UNI: two IT manufacturers would like to see the AGSS scope extended to cover 400
L/min. flows. IT could make a formal proposal.
II.3 ISO 5356-1:1996 cones and sockets
FV passed in ISO and CEN approved - with DE voting negative because of the rejection of the 11 mm
connector.
ISO 5356-2 / EN 1281-2 merger: requested by CEN TC 215 WG1 in 2003 and 2004: TL to review both
documents.
II.4 ISO FDIS 8835-4 anaesthetic vaporizers
Passed, published late May 2004.
II.5 ISO FDIS 8835-5 anaesthetic ventilators
Ditto.
II.6 ISO TS 18836 draw over vaporizers
Passed ISO CEN TC 121 vote. CEN does not see any value to republish an ISO TS as a CEN TS. T.S.
complaint about this. C.F.W.: merge with proposed part 6.
II.7 ISO FDIS 21647 anaesthetic gas monitors
Vote closes 6 July 2004. DIS comments were resolved November 2003.
II.8 NWIP ISO 8835-6 anaesthetic systems for remote and emergency area application
Failed. DE asks for reballoting in light of the fact that 13 countries did not responded and the interest
expressed by WHO Dr. Stefan Groth 4 June 2004. Addressed to Dr. Ronny Greenbaum, responded by
D.U. indicating lack of resources. R.G. suggested N.N. to act as liaise with WHO via WFSA world
federation of society of anaesthesiologist.
C.F.W. requested reballoting based of 12 P members not replying. CA, JA, FI, AU, IT are normally
pretty good in responding, plus BE, Brazil, NL, NZ, PT, Russian Fed. and SE did not respond.
M.G.: compare with NWIP non responder on blood warmers and heating blankets. C.F.W. requested
this.
D.U. refuses to follow Dr. Wallroth‟s third request and not to chase up the non responder.
R.B.: D.U. to report back to ISO CS that life link does not work always well. Automated e-mail
notification to be reinforced per C.J. IT IEC members receive e-mail information they have to confirm.
M.G.: suspicion that NWIP were never received e.g. by ANSI
C.J. time frame for reballoting?
D.U.: position a procedural one. Market changes with time, maybe after a couple of years.
C.F.W.: request for life link access data - denied by the secretary
US NWIPs to be considered accepted per Hancox, ISO CS because of evidence that there was not life
link access by the US.
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33rd ISO TC 121Anaesthetic and Respiratory Equipment ISM 2004-30
Milano / 14-18 June 2004 29 June 2004
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II.9 IEC 60601-2-13 anaesthesia systems
Corrigendum being processed based on Chinese input, i.e. Ms Lily Li.
II.10 ISO 8835-2:1999 anaesthetic breathing systems for adults
WG9 developed CD during the week - in light of the amalgamation of EN 740 and ISO 8835.
II.11 Technical corrigendum to ISO 5360 (EN 1280-1) agent specific filling systems
T.L. followed DE engineer suggestion and discontinued redrawing EN 1280-1 when two dimensions
need correction. EN 1280-1 has additional labelling requirements.
CEN TC 215 WG1 wants to see one standard. T.L. to prepare revision.
All countries present in favour of revision: AU, CA, DE, IT, JA, UK, US.
II.12 CEN TC 215 WG1 report
Chair asked C.F.W. to keep report brief.
C.F.W.: nothing to report, following the chair‟s request.
II.13 Work program
ISO CS is imposing rigorously 36 month rule.
II.14 Joint ISO TC 121 SC1 - IEC SC 62D JWG - anaesthesia workstation
Nothing to report.
II.15 ISO TC 121 SC1 WG1 hose assemblies
Nothing to report. Convenor Dr. David Peel resigned two years ago. Group is dormant.
II.16 ISO TC 121 SC1 WG5 - respiratory gas monitors
FDIS vote closes 6 July 2004.
II.17 ISO TC 121 SC1 WG6 - gas mixers
Group is dormant, chair D.P. resigned. Standard is probably up for review.
II.18 ISO TC 121 SC1 WG9 - anaesthetic systems
ISO DIS 8835-3 AGSS completed this week.
ISO CD 8835-2 anaesthetic breathing
DE proposed, UK seconded.
II.19 Future work
II.19.1 NWIP physiological closed controller
D.U.: delay work until ISO - IEC rearrangements are agreed.
C.F.W., J.G.: objection
R.G.: physiological variables interests SC1 as well as SC3.
J.G.: Zeus anaesthesia machine on the market in Europe
D.U.: reluctant to submit as ISO proposal
J.G., C.F.W.: mode 5 JWG, SC1, SC3 interests covered plus other technical committee.
M.G.: SC1 should support NWIP to the plenary. SC1 later could use process standard later to develop
specific et CO2, an. agent controller.
N.N.: UK is going back to nurse anaesthesia, could be dangerous in their hands.
J.G.: volume compensated ventilator examples
M.G.: US proposes to support NWIP submittal seconded by DE.
H.L.: SC3 proposes joint SC1/SC3 working group with IEC TC 62A.
Motion for NWIP via ISO TC 121 / IEC TC 62A mode 5 JWG IEC lead.
in favour: JA, DE, AU, CA, IT, US (6)
abstain: UK (1)
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33rd ISO TC 121Anaesthetic and Respiratory Equipment ISM 2004-30
Milano / 14-18 June 2004 29 June 2004
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II.19.2 ISO 8835-3 AGSS scope extension for 400 L/min.
IT to submit written comments on DIS.
II.20 Next TC 121 SC1 meetings
13 to 17 June 2005 Lübeck (1 day)
05 to 09 June 2006 Helsinki
signed
Dr. Carl F. Wallroth
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Milano / 14-18 June 2004 29 June 2004
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III. ISO TC 121 SC1 WG9 anaesthetic workstation
Chair: Dr. Christopher Joseph, AU
Secretary: Mr. Mark Graber, US
Participants: 10 delegates from AU, CA, DE, IT, JA
Place/Date: Milano / 14 and 15 June 2004
III.1 ISO FDIS 8835-4 anaesthetic vapour delivery devices
18 positive votes, no negative, publishing date 1 June 2004 but no confirmation.
III.2 ISO FDIS 8835-5 anaesthetic ventilators
18 positive votes, no negative, publishing date 1 June 2004.
M.G. purchased copy but not jet received.
III.3 ISO CD 8835-3 AGSS - transfer and receiving system
13 members did not vote
FR, DE, Korea Rep., NL, SP, CH = 6 positive
UK: disapprove
South Africa: abstain
no response: AU, BE, Brazil, CA, FI, IT, JA, Korea, NZ, PT, R Fed., SE, US = 13
close: 2004.02.28 compl: 2004.03.05
It appears that life link might not have working fully based on the large number of no responses.
Review of comments
Only UK responded with 61 comments.
Proposal to reject working draft (prepared by splinter group following 2000 St. John TC 121 SC1
decision) and reconfirm ISO 8835-3 not found persuasive.
Introduction
Text of ISO 8835-3 added, which was however not available because group stopped.
Scope
…. intended to reduce the exposure of hospital personnel to anaesthetic gases and vapours while
providing patient protection against excessive flow and pressure.
This standard does not specify requirements for
- disposal systems which are covered by ISO 7396-2
- non-active AGSS (passive AGSS)
- proximity gas extraction system
- transfer and receiving systems used with flammable anaesthetics, AGSS was determined in
annex DD
Note 1: moved into first under
Note 2 and 3: moved into rationale, addressing recommendations for non-active AGSS or proximity gas
extraction system for which no standards exist.
Exclusion to be left in scope to avoid misapplication of standard, e.g. by test houses.
5.1.1 pressure
delete „rise‟
5.1.4 leakage - unchanged
Rationale:
leakage is normal condition, „spillage‟ is single fault condition.
Text modified:
…. shall be less than 100 mL/min. with fresh gas flows 10 L/min.
6.1.2b) alternative means of interchangeable transfer tube construction, e.g. wire reinforce tube, meeting
200 N compression test - not accepted, all interchangeable transfer systems need to have a 30 mm
conical connector and a means of pressure relief. This is more stringent than the original CEN and ISO
requirements which made means of pressure relief conditional on 30 mm conical connector.
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NARK-DKE-ISO Participants’ Meeting Report mt-pq-ism/dr.cfw-mö
33rd ISO TC 121Anaesthetic and Respiratory Equipment ISM 2004-30
Milano / 14-18 June 2004 29 June 2004
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8.4 If provided connectors into the AGSS for the scavenging of sample gas from a diverting respiratory
gas monitor shall not be compatible with ISO 594-2
Rationale: connectors are not mandated, but encouraged, connector is under development - i.e. Datex
sleeved luer, presently persuade via revision of EN 13014.
11 Electrical requirements
Note about clause 37 APG equipment deleted, fourth indent to scope added, annex DD (normative) test
for determining flammability of anaesthetic agents.
14 Identification
Add: Note: magenta could be e.g. …. in the Munsel book of colours. - to be added to Bibliography.
Next step for ISO 8835-3 AGSS
Move document to DIS/prEN stage, subject to SC1 confirmation.
III.4 NWIP ISO 8835-6 anaesthetic systems for remote and emergency area application
voting in favour: FR, DE, Korea Rep., South Africa (4) needed: 5
against UK (1)
abstain SP, CH, US (3)
participation FR, DE, UK, US (4) needed: 5
not replying AU, BE, Brazil, CA, FI, IT, JA, NL, NZ, PT, Russ.Fed., SE (12)
Apparently the US vote was a single executive board member decision without consultation of e.g. the
US ASTM members, who helped to prepare the working draft.
WHO expressed interest and concern that the project moves ahead.
DE has requested to resubmit the NWIP due to lack of e.g. responding countries.
The technical specification to become part of the proposed part 6.
III.5 ISO WD 8835-2 anaesthetic breathing systems
63 comments were received from the UK; apparently US comments were not forwarded.
UK proposal to reject working draft prepared by splinter group following 200 St. John TC 121 SC1.
Title: anaesthetic breathing system (for adults - deleted) - carried
Scope: delete „for use with neonates, paediatric and adult patients‟
because of difficulties to define.
2nd sentence deleted after some arguments on inclusion of exhaust valve or not.
Rearrange clause 4 into three clauses.
4. General requirements and alternative test methods
make identical with ISO 8835.3 AGSS
4.1 Materials
4.2 Electrical requirements
4.3 Alternative test methods
lift text from ISO 8835.3 AGSS
5. Connectors
6. Bag / ventilator selector switch
Comments relate to WD numbering.
4.1.3 Exhaust port
delete note 3 and note 4.
for connection to an AGS interchangeable system a 30 mm male connector complying with ISO 5356-1
for connection to an AGS transfer system
a) proprietary fitting(s) incompatible with connectors complying with ISO 5356-1 and breathing tubes
complying with ISO 5367, or
b) non-operator detachable connection(s) to the AGS transfer hose(s) - not carried
b) the AGS transfer hose(s) shall not be detachable by the operator - not carried
b) non-operator detachable from the transfer system inlet - carried.
4.1.4 Connection port for reservoir bag
…. vertical or +/- 20° of the vertical axis with the port facing down ward - unchanged.
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May be linked with 22 mm male connector.
Add editor‟s note: members to review 22 mm female connection mandated in Australia as an alternative
construction. - to be revisited.
Two accidents in DE with expiratory hose connected to the connection port for the reservoir bad were
debated. ISO TC 121 was founded in 1965 to standardize the 22 mm conical connectors to overcome a
multitude of connectors and disconnections. It took 21 years towards 1986 to complete ISO 5358-1.
4.1.7 Inspiratory and expiratory ports of a circle absorber assembly
Discussion about the horizontal + 50° ergonomic orientation as in EN 740. UK proposal to delete
geometric requirement as in ISO 8835-2 not carried.
Editor‟s note added for manufacturers to explore how much of the + 50° is being utilized. -45° is used
for avoidance of kinking of hoses and water trapping in water traps. Ergonomics requirements need to
be design restrictive, e.g. steering wheels, clutch and brake for motor cars.
4.1.8 Ports of non-re-breathing exhaust valves
Move to exhaust port section.
4.1.9 Gas sampling connections
UK proposal to disallow luer connector following CEN BT TF 123 recommendation not supported by
DE, CA, UK manufacturer. SC2 resolution in support of luer connectors, probably for tracheal tube cuff
inflation.
The gas sampling outlet port of the breathing system shall be a female luer connector complying with
ISO 594-1. - unchanged.
The gas sampling return port, if provided, shall not be compatible with ISO 594-1.
4.1.10 Other ports
…. shall not have connectors complying with ISO 5356-1, ISO 5356-2 or ISO 594-1.
4.3 Electrical requirements
Unchanged.
4.4 Materials
…. reduce to a minimum the risks posed by substances leached from the device.
5. Breathing systems supplied assembled
UK wants to introduce the concept of work of breathing as done in ISO 8835-2:1999. Work of
breathing relates to resistance to flow per A.G., M.G., K.T., consequently measuring the resistance at a
constant flow is sufficient. Long tube scenario in MRI machines, e.g. 4 m, discussed. Work of breathing
concept will not be persuading further.
EN 740 is used for compliance demonstration with the essential principles of the medical devices
regulations. Any changes to a harmonized standard should be substantiated e.g. with regulatory
evidence, change of the state of the art.
150 mL/min. max. leakage remains unchanged, considered the end of a trumpet curve, i.e. the
maximum considered safe. Manufacturers will design for much tighter tolerances and maintain
equipment in the field for intermediate tolerances.
The pressure generated at the patient connection port shall not exceed 0.6 kPa (6 cm H 2O) at flows of
5 L/min., 30 L/min. or 60 L/min. according to the intended use. - Reference to neonatal, paediatric and
adult application deleted.
8.1 Pressure monitoring
Range from -1 kPa (-10 cm H2O) to +6 kPa (60 cm H2O) added editor‟s note added: manufacturers to
check if appropriate, EN 740 does not specify range.
8.2 Pressure limiting device
Added:
Note: See clause 51.101.1 in IEC 60601-2-13:2003 - which mandates such devices.
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11. Information to be provided by the manufacturer
a) for breathing systems and breathing system attachment
14) …. does not exceed ….
15) …. does not exceed ….
b) for breathing systems supplied complete
1) deleted
Next step
M.G. to revise document in light of the discussions, i.e. excluding the work of breathing and circulate as
CD.
III.5 Next meeting of WG9
Lübeck June 13-17, 2005 for about 2 ½ days
for ISO DIS 8835-3 AGSS and ISO CD 8835-2 breathing system comments.
signed
Dr. Carl F. Wallroth
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IV. ISO TC 121 SC3 respiratory equipment
Chair: Prof. John Hedley-Whyte, US
Secretary: Mr. David Osborn, US
Participants: 26 delegates from CA, DE, FI, IT, JA, UK, US,
Place/Date: Milano / 14-18 June 2004
IV.1 John Hedley-Whyte was reconfirmed as chairman for an additional 3-year term
IV.2 New work item: Process requirement for the development of physiologic closed-loop controllers
This new work item should be handled by a joint working group between IEC TC62A and ISO
TC121/SC1 and ISO TC121/SC3. During the discussion at the plenary questions arose whether a JGW
between 3 parties is possible since some national bodies are members of SC1 only and others of SC3
only. The secretary of TC 121 will resolve this bureaucratic issue.
IV.3 Collaboration between IEC TC62 and ISO TC121
ISO TC121/SC3 proposed the formation of a joint sub-committee between ISO TC121 and IEC TC62
(see attached document N1172). This proposal was not fully accepted by the other sub-committees
during the meeting of the Chairman Advisory Group. It was decided during the plenary session that a
group is formed to negotiate the details of a closer co-operation between IEC and ISO. This group
consists of the chairmen and secretaries of ISO TC121, the sub-committees SC1, SC2 and SC3 and, in
addition, Carl Wallroth and Mark Graber.
IV.4 Revision of ISO 17510-1 – Sleep apnea therapy devices
ISO 17510 consists of two parts. Part 1 deals with the devices and part 2 with masks and accessories.
The ballot period for part 2 was not finished. Therefore some members of the American delegation
proposed to postpone the discussion about the comments on part 1 to the next SC3-meeting in
Stockholm. This had also allowed the American group to add some more comments during their
national meeting in August. This proposal was not accepted.
The major issues (in addition to the many editorial comments or technical comments of minor
importance) discussed were:
- The US requested to label flow-direction sensitive components with the word “flow” in
addition to an arrow. This was rejected.
- The US requested to eliminate the measurement conditions for the emitted sound since they
regarded this as a marketing issue and not a safety issue. This proposal was rejected since the
safe and effective use of the equipment depends essentially on the acceptance by the patient.
- The test of the maximum working pressure limitation (annex DD) was deleted. After lengthy
discussion the committee followed the German position that such a test must be design
specific.
The discussion of all of the comments could not be finished. Therefore a second CD will be published
and will be discussed together with part 2 during the interim meeting in Stockholm.
IV.5 ISO 10651-5 Gas powered emergency resuscitators
The major issues (in addition to the many editorial comments or technical comments of minor
importance) discussed were:
- The scope was clarified. The rationale will contain a statement to the effect that those devices
are considered as a substitute for mouth-to-mouth resuscitation. This makes it clear that such
devices cannot be used as low-cost substitutes for devices complying with part 3 of the 10651-
series.
- The current draft permits a dead-space of 100 ml or 30% of the minimum tidal volume.
However, the FDA insists (for unknown and barely understandable reasons) on a dead-space of
less than 5.5% of the minimum tidal volume. Therefore the following modification was made
that is expected to satisfy the FDA: “The resuscitator dead-space excluding the face mask,
shall not exceed 5.5% of the minimum delivered volume. The dead-space of any combination
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of components for attachment to the resuscitator including the face mask shall not exceed 100
ml or 30% or the minimum delivered volume, whichever is smaller”.
Standard will be circulated as a DIS.
IV.6 ISO 23328 Breathing filters
This standard consists currently of two parts: Part1: “Salt-test” and Part2: “Non-Filtration Aspects”. A
Part3: “Microbial challenge test” is still lacking. The FDA doesn‟t accept any filter tests that have not
been carried out with microbial organisms since the other tests are not able to show the effectiveness of
such filters under clinical conditions. Klaus Züchner (Göttingen) gave a presentation of his ideas how
such a microbial challenge test could be carried out. The FDA is currently preparing a guidance
document about what shall be reviewed in a 510k-approval of microbial filters.
IV.7 Miscellaneous
- The German BfArM has written a letter to the European Commission with the request not to
harmonize the IEC-60601-1-8 standard (Alarms) because it permits the permanent disabling of
alarms. The BfAM holds the opinion that a collateral standard should have the most stringent
requirements which may be lowered in particular standards and not the opposite. An aide
memoir was prepared to assist CFW in his discussions with BfAM.
- There was some discussion to which extent standards can be used for assessment of conformity
with the Essential Requirements. There was general agreement that meeting a standard does
not make risk assessment obsolete.
signed
Dr. Dieter Weismann
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V. ISO TC 121 SC6 medical gas systems
Chair: Dr. David Peel, UK
Secretary: Dr. Susan Dorsch, US
Participants: 19 delegates from AU, BE, CA, DE, FR, IT, JA, SE, SP, UK, US
Place/Date: Milano / 14-18 June 2004
Name Affiliation Country
David Peel, PhD Ashdown Cons., Hartfield, E.Sussex UK
Susan Dorsch, MD Jacksonville, FL US
Derek R. Kirby RPC, Fredericton, NB CA
Francois Simondet, PhD Air Liquide, Paris FR
Bernard Zenou NOVAIR, Paris FR
Giorgio Fusato, PhD UNI, Sona IT
Elio Patetta Delta P, San Giacomo IT
Alfredo Galassini UNI concultant IT
Lorenzo Messa SOL. Monza, Milano IT
W. John Russell, MD Adelaide Uni., Adelaide AU
Jan Strybol Medical Air Products, Wavre BE
Tadashi Okada Kawasaki, Kobo JA
Sinichio Ko Central Uni, Fukuoka JA
Hiromichi Ito Tokyo Medical & Dental Uni, Tokyo JA
Björn Löfquist SIS, Stockholm SE
Bob Jacobson Airsep Corp., Buffalo, NY US
Ravi Bansal Airsep Corp., Buffalo, NY US
Klaus Züchner, PhD Uni Göttingen, Göttingen DE
Fernando Benavente Carburos Metallicos, Madrid SP
___________________________________________________________________________
total 19
V.1 Agenda
Document N 484, was adopted.
V.2 Drafting committee
Derek Kirby, Francois Simondet and Björn Löfquist
V.3 Approval of the minutes of the previous meeting held in Melbourne, February 2-6, 2004
Document N 471 was approved.
V.4 Review and discussion of secretariat report N 485
Derek Kirby reported the progress made at CEN level on the revision of ISO 7396-1 Medical gas
pipeline systems - Part 1 Pipeline for compressed medical gases and vacuum.
ISO 10524-1, Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure
regulators with flow-metering devices has been distributed as a DIS (and not an FDIS) for comment and
voting before November 2004.
The scope of ISO 10524-4 Pressure regulators for use with medical gases - Part 4: Low pressure
regulators which was submitted as a NWIP to ISO Geneva was discussed and the minutes of the
meeting will reflect that the scope is excluding pressure regulators integrated in medical devices
intended to be connected to medical gas supply system.
SC6 issues the following resolutions
Joint revision of EN ISO 9170-1:1999, Terminal units for medical gas pipeline systems - Part 1:
Terminal units for use with compressed medical gases and vacuum under Vienna Agreement ISO lead.
Joint revision of EN ISO 9170-2:1999,, Terminal units for medical gas pipeline systems - Part 2:
Terminal units for anaesthetic gas scavenging systems under Vienna Agreement ISO lead.
Joint revision of EN ISO 15002:2000, Flow-metering devices for connection to terminal units of
medical gas pipeline systems under Vienna Agreement ISO lead.
Joint revision of EN ISO 7396-2:2000, Medical gas pipeline systems - Part 2:
Anaesthetic gas scavenging disposal systems under Vienna Agreement ISO lead.
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Joint revision of EN ISO 7396-2:2000, Medical gas pipeline systems - Part 2:
Anaesthetic gas scavenging disposal systems under Vienna Agreement CEN lead.
V.5 Continued discussion of comments on ISO CD 10083.3, Oxygen Concentrator
Supply Systems for use with medical gas pipeline systems N 445
Documents to be considered in addition to N 445 are:
- Collated comments N 446
- Japanese comments N 437
- Belgian comments N 438
- Comments from SC4 on definitions N 448
- Report of drafting committee
The work was carried out started from Monday pm and continued Tuesday all day and Wednesday all
day.
Review of comments N 434 on N 404 ISO DIS 19054, Rail systems for supporting medical
equipment.
The work was carried out all day Thursday.
Future meetings
ISO TC 121 SC6 will meet in St. Augusstine, FL, January 24-28, 2005.
signed signed
Dr. Francois Simondet Dr. Anselm Bräuer
Dr. Klaus Züchner
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Participants
Name Affiliation Country TC SC1 WG9 SC3 SC6 TC
June 14 16,17 14,15 14-18 14-18 18
____________________________________________________________________________________________________
Daniel Supkis M.D. Anderson Cancer Ctr, Houston, TX US -
David Osborn Philips Medical Syst., Andover, MA US x x x
Mark Graber Datex-Ohmeda, Madison, WI US x x x x
Matti Hakala Datex-Ohmeda, Helsinki FI x x x
Terry Longman Exmouth, Devon UK x x x x
Don Reimer, MD (retired) Winnipeg, MB CA -
Toyoki Kugimiya, MD Juntendo Uni. School of Med., Tokyo JA x x x x
K. Yasumoto Skowa Uni. Hosp., Tokyo JA -
Ian de Jersey, MD Wahroonga AU -
Mustafa Anki TAEMA, Antony FR -
Anders Skoglund Siemens-Elema, Solna SE -
Jeremy Sloan, MD Hospital for Sick Children, Toronto CA x pt x
Carl F. Wallroth, PhD Draeger Medical, Luebeck DE x x x pt x
Helmut Thiemann DMI, Telford US -
Stanley Weitzner, MD Duke University /Chapel Hill, NC US -
Tom Shanks MD Ventures, Temecula, CA US -
Robert Virag, PhD Trifid Medical Group US x pt x
Steven Mawn ASTM, West Conshohocken US -
Debra Milamed Harvard Univ. Boston US -
Hideo Ozawa Nihon Kohden, Tokyo JA x x x
Steve Ogilvie Portex, Kent UK -
Michael Zang Respironics, Murrysville, PA US -
Michael Jaffe,PhD Novametrix, Wallingford, CT US x x x
Ravi Bansal Airsep Corp., Buffalo, NY US - x
Bob Jacobson Airsep Corp., Buffalo, NY US - x
David Upstone BSI, London UK x x x
Tony Nightingale, MD Liverpool UK -
Peter Carstensen FDA Rockville US -
Michael Weir Johnson & Johnson Cincinnati, OH US -
Mark Faigman, MD Monash Medical Centre, Clayton AU x x x x
Christopher Joseph,MD Austr.&New Zealand College o.An.Melb. AU x x x x
Bo Kjelltoft Sahlgrenska Univ.Hosp.,Göteborg SE -
Douglas Vandine Tyco-Nellcor, Pleasanton, CA US -
Nick Newton, MD Guys Hospital, London UK x x x x
David Peel, PhD Hartfield UK x x x
Susan Dorsch, MD Jacksonville, FL US x x x
Derek R. Kirby RPC, Fredericton, NB CA x x
Hiromichi Ito, MD Tokyo Medical and Dental University JA - x x
Francois Simondet, PhD Air Liquide, Paris FR x pt
Klaus Züchner, PhD University of Goettingen DE x pt x x
Giorgio Fusato, PhD Sona IT x x
Tadashi Okada Kawasaki, Kobe JA x x x
Stephen Parkinson Hill-Rom Medaes, Stavely UK -
Yasutaka Iga Kawasaki, Kobe JA -
Kenichi Nagashima Koike Med., Tokyo JA -
John Russell, MD Adelaide Univerity AU x x x
Kenshiro Hashimoto Central Uni, Tokyo JA -
Shinicho Ko Central Uni, Fukuoka JA x x x
Björn Lövqvist SIS Stockholm SE x x x
Brett Whiston Fisher and Paykel, Auckland NZ -
Harno Maeda Kawasaki, Kobe JA -
Ronny Greenbaum, MD London UK x x pt pt x
Michael Blackhurst Fisher and Paykel, Auckland NZ -
Ken LeDez, MD Health Science Center, St. John‟s NF CA -
Akito Ohmura, MD Teikyo University, Tokyo JA x x x
Steve Ogilvie Portex, Hythe, Kent UK -
Earl Gardiner Rana Medical, Morden, MO CA -
Keloin Lewis Rimer-Alco, Cardiff UK -
Hubertus Lasthaus VitalAire Bremen DE x x x
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Name Affiliation Country TC SC1 WG9 SC3 SC6 TC
June 14 16,17 14,15 14-18 14-18 18
____________________________________________________________________________________________________
Dieter Weismann, PhD Draeger Medical Luebeck DE x x x
Len Berman, PhD Pall Medical, New York, NY US -
Warren Sanborn, PhD Puritan Bennett/Tyco Healthcare US - x x
Brett Whiston Fisher and Parker, Auckland NZ -
Steven Dain, MD London Health Sciences Center, ON CA x x x pt
Jerry Dorsch, MD Mayo Clinic, Jacksonville, FL US -
John Hedly-Whyte, MD Harvard Uni Boston US x x x
Julian Goldman, MD Massachusetts General Hospital, Boston US x x
Ann Graham FDA, Rockville, MA US x pt x
Peter Thompson, MD CEN, Brussels UK -
Norman Jones, PhD British An.&Resp.Equip.Manuf.Assoc. UK x x x
Yosuhiro Shimada, MD Nagoya Univ. Hosp., Nagoya JA -
Tetsuo Inoue Chiba Hakason Hosp, Chiba JA x
John Stevens, MD London UK x pt
Steven Orwig Ohmeda Medical Instr., Laurel, MD US -
Fred Evans Medical Gas Man c/o ASTM US -
James Moody Med. Gas Serv., Lakemba, NSW AU -
Paul Batchelder Datex Ohmeda, Louisville, CO US -
Robert Kopotic Masimo, Irvine, CA US -
Paul Mannheimer Nellcor/Tyco, Pleasanton, CA US -
Sandy Weininger FDA, Rockville, MD US -
Matthew Payton Fisher and Paykel, Auckland NZ -
Bernard Zenou NOVAIR, Paris FR x x
Timothy Hancox ISO CS, Geneve UK -
Francois Chausset CAHOUET, Paris FR -
Bill Rich Omegaflex Inc., Westfield US -
Harold Beeson, PhD NASA, JSC White Sands Test Facility US -
Mike Wilson Bristol UK -
Bernd Koehler Welch Allen, Scenatilty Falls, NY US -
Donald Short, MD BSI, London UK -
Hartmut Gehring, MD MuzL, Lübeck DE -
Holger Matz MuzL, Lübeck DE -
Alan Green Penlon, Ltd., Oxford UK x x x
Wulf Trepte MDRS Europe, Sollentuna SE -
Hideki Miyao Saitamo Med., Saitama JA x x
Makoto Magara Fukuda Denshi, Tokyo JA x x x
Bryan Peterson Fisher & Paykel, Auckland NZ -
Kevin Bowden O-Two System, Mississanga, Ont. CA - pt x
Robert Gottesman FDA, Rockville, MD US -
Michael Dodd CSA, Mississanga, Ont. CA x x x
Michael Johansson Siemens-Elema, Solna SE -
Henrik Laenö Dameca, Copenhagen DK -
Kenshiri Haschimoto Central Uni, Fukuoka JA -
Jan Strybol Air Products, Brussels BE - x
Niels Lomholt DS, Copenhagen DK x x
Amsel Bäuer, MD Uni. Göttingen DE x pt
Torsten Schlichtholz MPG, München DE x x
Karen Brown, MD CSA Canada, Toronto CA x pt
Lorenzo Messa SOL. Monza, Milano IT - x
Fernando Benavente Carburos Metallicos, Madrid SP x x
Elio Patetta Delta P, San Giacomo IT x x
Alfredo Galassini UNI consultant IT x x pt x x
Anthony Cicarrello . US x pt
____________________________________________________________________________________________________
total 48 13 10 26 19 36
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