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					NARK-DKE Participants’ Meeting Report                                                                              mt-pq-ism/dr.cfw-mö
ISO TC 121 SC6 Medical Gas Systems                                                                                 ISM 2005-07
St. Augustine / 24-28 January 2005                                                                                 7 February 2005
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Participants                                                                 NBM/021/05
13 delegates from AU, BE0, CA, DE, DK0, FR, IT, JA, SE0, UK, US
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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 / F&O 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
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Address
La Quinta Inn
1300 N. Ponce de Leon Boulevard
St. Augustine, FL 32084
USA
Tel. +1-904-824-3383
Fax +1-904-829-0668
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Place/Date
St. Augustine / 24-28 January 2005
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Subject
ISO TC 121 SC6 Medical Gas Systems
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Chair:            Dr. David Peel, UK
Secretary:        Dr. Susan Dorsch, US seconded by Mark Graber, US
Place/Date:       St. Augustine / 24-28 January 2005
Participants:     13 delegates from AU, BE0, CA, DE, DK0, FR, IT, JA, SE0, UK, US

Executive Summary
ISO TC 121 SC6 hold is semi-annual meeting in St. Augustine with the following achievements and
observations:

    ISO FDIS 10524-3.2 Pressure regulators for use with medical gases - Part 3:
     Pressure regulators integrated with cylinder valves
     Document was moved to FDIS stage at the 2 to 6 February 2004 Melbourne meeting;
     FDIS to appear 11 February 2005 for two month voting.


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NARK-DKE Participants’ Meeting Report                                                                              mt-pq-ism/dr.cfw-mö
ISO TC 121 SC6 Medical Gas Systems                                                                                 ISM 2005-07
St. Augustine / 24-28 January 2005                                                                                 7 February 2005
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     (Delay originated from the drawings being upside down to be made acceptable for Geneva CS which the
     secretary resolved with the help of a CAD system bought on her own expenses.)
    ISO FDIS 10524-2.2 Pressure regulators for medical gases - Part 2:
     Manifold and line pressure regulators
     Document was moved to FDIS stage at the 2 to 6 February 2004 Melbourne meeting;
     FDIS to appear 11 February 2005 for two month voting.

    ISO DIS 10524-1 Pressure regulators for use with medical gases - Part 1:
     Pressure regulators and pressure regulators with flow metering devices
     Scope was modified and Part 4 - destructed in Auckland in 2002 by an US / M.G. comment to exclude
     internal pressure regulators from the scope - was reintroduced.
     Part 1: pressure regulators up to 25000 kPa for gas cylinder
     Part 4: pressure regulators up to 3000 kPa for medical gas pipeline systems - excluding regulators within
     medical devices. Part 1 with revised scope was aligned with Part 3 conclusions in Melbourne by D.P., G.F.
     and moved to DIS stage. Part 4 with modified scope was prepared by D.P., B.H., S.D. and circulated as
     working draft WD, see below.

     150 comments were received on DIS 10524-1 from AU, US, FR, CEN, CZ, JP, BE, DE and were resolved:
     Late DE comment on disinfection information added to manufacturer’s declaration.

     BE comment to delete ‘use no oil’ and mandate symbol only because ASTM/US experience of technician to
     use NO type oil - not carried.
     ISO 11114-3:1997 autogenously ignition test in oxygen atmosphere added to mandatory reference.
     AU and CEN proposal to delete compliance requirement in 5.2 alternative construction not carried because
     considered fundamental, note added, paragraph to read:

     5.2 Alternative construction
     … using materials or having forms of construction different from those detailed
     … shall be accepted if it can be demonstrated that an equivalent degree of safety is obtained. - unchanged.

     Note: attention is drawn to ISO 14971 on risk management … deleted ISO 14971 is mandatory reference.
     Such evidence shall be provided by the manufacturer upon request. - unchanged.
     Note: regional or national regulation may require the provision of evidence to a notified body or competent
     authority upon request. - new note, reflects content of rationale in CEN standards accompanying this clause
     - carried.

     Proprietary connectors
     Proprietary connector replaced by manufacturer specific connector because ‘proprietary’ is not part of the
     Australian shine.

     Bin Laden test
     G.W. to prepare for US a NWIP with justification for Bin Laden test firing up regulators with Mg pills
     based on ASTM G4 experience, to become stand-alone standard or amendment to EN ISO 15001 oxygen
     compatibility.

     Accuracy
     Ad-hoc group to develop revised wording M.B. coordinator, F.C., R.H., D.L.
     Document moved to FDIS stage.

    ISO WD 10524-4 Pressure regulators for use with medical gases - Part 4: low pressure regulators
     1. Scope
     1.1 … applies to the types of low pressure regulators listed in 1.2 designed for a maximum inlet pressure of
     3000 kPa, intended for use … :
     - oxygen
     - nitrous oxide
     - air for breathing
     - helium
     - carbon dioxide
     - xenon
     - mixtures of the gases listed above

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NARK-DKE Participants’ Meeting Report                                                                              mt-pq-ism/dr.cfw-mö
ISO TC 121 SC6 Medical Gas Systems                                                                                 ISM 2005-07
St. Augustine / 24-28 January 2005                                                                                 7 February 2005
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     -    air for driving surgical tools
     -    nitrogen for driving surgical tools

     1.2 The types of low-pressure regulators covered …
     - low-pressure regulators intended to be connected to terminal units of medical gas pipeline distribution
         systems complying with ISO 7396-1;
     - low-pressure regulators with integral flow-metering devices intended to be connected to terminal units
         of medical gas pipeline distribution systems complying with ISO 7396-1;
     - operator adjustable low-pressure regulators that are integral part of a medical gas distribution system
         complying with ISO 7396-1, for air or nitrogen for driving surgical tools.

     1.3 This Standard does not apply to low-pressure regulators integrated within anaesthetic and respiratory
     equipment.
     …
     Document moved to CD stage.

    EN ISO 9170-1:1999 Terminal units for medical gas pipelines - Part 1
     Terminal units for use with compressed medical gases and vacuum
     Submitted for five year systematic review with a closing date of 31 March 2005. This was done by mistake,
     ISO had proposed joint revision under the Vienna Agreement with ISO lead and CEN TC 215 had accepted
     the offer. Systematic review will be withdrawn and NWIP registered by US; existing document will be
     attached and member bodies will be asked if sufficient to be submitted as CD or DIS.

    EN ISO 9170-2:1999 Terminal units for medical gas pipeline systems - Part 2
     Terminal units for anaesthetic gas scavenging systems
     Ditto.
     Decision by CEN to delete high flow AGSS with incomplete 75 L/min specification require modification,
     i.e. deletion of high AGGS terminal unit.

    EN ISO 15002:2000 flow-metering devices for connection to terminal units of medical gas pipeline
     systems
     Ditto.

    ENV 737-6 Medical gas pipeline systems - Part 6: Dimensions and allocation of probes for terminal
     units for compressed medical gases and vacuum
     Rejected by AU at the Melbourne meeting as being fit for introduction into the international domain before
     Europe got its act together and promotes the pre-standard to a harmonized European standard and the system
     is validated as commercial product.

    Pipeline pressure limits CEN TC 215 WG3 N389
     Minutes of the Sept. 3, 2003 meeting with H.B., F.C., T.D., G.F., M.N., F.S., C.F.W. were noted. DE had
     already objected at Madrid meeting about the attachment to the minutes stating the position of two biased
     pipes that pipelines could fail at 1000 kPa and discontinue continuity of supply. EUROM VI moderated ad-
     hoc group on 16 March 2004 in Lübeck which resolved dual pressure regulators for single stage and dual
     stage pipeline systems.

    ISO FDIS 21969 High-pressure flexible connections for use with medical gas systems
     Comments received from the DIS enquiry were resolved and document was moved to FDIS stage at the
     Melbourne meeting.

    Next meetings
     CEN TC 215 WG3                                  14 to 16 March 2005             Lübeck
     CEN TC 215 WG1 and WG2                          27 to 30 April 2005             Vienna
     ISO TC 121 etc.                                 13 to 17 June 2005              Lübeck


signed                                                          signed

Dr. Carl F. Wallroth                                            Dieter Linz

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NARK-DKE Participants’ Meeting Report                                                                              mt-pq-ism/dr.cfw-mö
ISO TC 121 SC6 Medical Gas Systems                                                                                 ISM 2005-07
St. Augustine / 24-28 January 2005                                                                                 7 February 2005
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Participants

Name                   Affiliation                            Country Jan.24 25 26  27  28
David Peel, PhD        Ashdown Cons.,Hartfied,E.Sussex          UK        x   x  x   x
Susan Dorsch, MD       Jacksonville, FL                         US        x          x
Derek R. Kirby         RPC, Fredericton, NB                     CA        x   x  x   x
Francois Simondet,PhD Air Liquide, Paris                        FR
Carl F. Wallroth,PhD   Dräger Medical Lübeck                    DE            x  x   x
Giorgio Fusato, PhD    Uni Sona                                 IT        x   x  x   x
Stephen Parkinson      Hill-Rom Medeas, Stavely                 UK
Earl Gardiner, CA      RANA Med, Morden, MB                     CA
W. John Russell, MD Adelaide Uni., Adelaide                     AU
Jan Strybol            Medical Air Products, Wavre              BE
Francois Chaussat      CAHOUET, Paris                           FR        x   x  x   pt
Alain Terraz           NOVAIR, Sevran                           FR
Henrik Laenoe          Dameca, Copenhagen                       DK
Kenshiro Hashimoto     Central Uni, Tokyo                       JA
Tadashi Okada          Kawasaki, Kobe                           JA        x   x  x   x
Sinichio Ko            Central Uni, Fukuoka                     JA
Kenichi Nagachino      Koike-medical, Tokyo                     JA
Hiromichi Ito          Tokyo Medical and Dental Uni, Tokyo JA
Bjørn Løfquist         SIS, Stockholm                           SE
Dieter Linz            Messer C & W, Frankfurt                  DE        x   x  x
Peter Henrys           BOC, Guildford, Surrey                   UK        -
Bob Hobbs              Gas Control Equ.,Warrington,Cheshire UK            x   x  x   x
Bob Jacobson           Airsep Corp., Buffalo, NY                US
Ravi Bansal            Airsep Corp., Buffalo, NY                US
Bernard Zenou          NOVAIR, Paris                            FR
Klaus Züchner          Uni Göttingen, Göttingen                 DE
Christopher Joseph, MD Aust.&New Zealand Collage of An.,Melb.   AU
Max Boccardo           Max Boccardo Assos., Toorak, VIC         AU        x   x  x   x
Mark Graber            GE Medical, Madison, WI                  US        x   x  x   x
Rupert Ferdinands      Standards Australia, Melbourne           AU
Hiroshi Uno            Kawasaki, Tokyo                          JA        x   x  x   x
Bill Rich              Omegaflex, Westfield, MA                 US        x   x  pt
Gwenael Chiffoleau,PhD Wendell Hull, La Cruces, NM              US        x   x
David Riegel           Key Instr., Trevose, PA                  US                   x
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total                                                                     13 13 12   12




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