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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
----------------------------------------------------------------------------------------------------------------------------- -----------

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
----------------------------------------------------------------------------------------------------------------------------- -----------

          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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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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          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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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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               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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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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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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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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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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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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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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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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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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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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          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.

                                                                                                                                     10
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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




                                                                                                                                     11
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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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


                                                                                                                                     12
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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                     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




                                                                                                                                     13
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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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.

                                                                                                                                     14
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33rd ISO TC 121Anaesthetic and Respiratory Equipment                                                              ISM 2004-30
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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




                                                                                                                                     15
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
----------------------------------------------------------------------------------------------------------------------------- -----------

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


                                                                                                                                       16
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
----------------------------------------------------------------------------------------------------------------------------- -----------

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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