DIN EN ISO 10524-3-2013 Pressure regulators for use with medical gases - Part 3 Pressure regulators integrated with cylinder valves (ISO 10524-3 2005 + Amd 1 2013) German version E.pdf

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1、June 2013Translation by DIN-Sprachendienst.English price group 18No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11

2、.040.10; 23.060.40!%T“2022549www.din.deDDIN EN ISO 10524-3Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves(ISO 10524-3:2005 + Amd 1:2013);English version EN ISO 10524-3:2006 + A1:2013,English translation of DIN EN ISO 10524-3:2013-06Druckmind

3、erer zur Verwendung mit medizinischen Gasen Teil 3: Druckminderer in Flaschenventilen (ISO 10524-3:2005 + Amd 1:2013);Englische Fassung EN ISO 10524-3:2006 + A1:2013,Englische bersetzung von DIN EN ISO 10524-3:2013-06Dtendeurs pour lutilisation avec les gaz mdicaux Partie 3: Dtendeurs intgrs dans le

4、s robinets des bouteilles de gaz(ISO 10524-3:2005 + Amd 1:2013);Version anglaise EN ISO 10524-3:2006 + A1:2013,Traduction anglaise de DIN EN ISO 10524-3:2013-06SupersedesDIN EN ISO 10524-3:2006-07See start of applicationwww.beuth.deIn case of doubt, the German-language original shall be considered a

5、uthoritative.Document comprises 42 pages06.13 DIN EN ISO 10524-3:2013-06 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2013-06-01. DIN EN ISO 10524-3:2006-07 may be used in parallel until 2016-02-29. National foreword This standard has bee

6、n prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom) in collaboration with ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: ANSI, USA). The responsible German body involved in its preparation was the Normenausschuss R

7、ettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Working Committee NA 053-03-06 AA Zentrale Gasversorgungsanlagen. This standard includes Amendment A1 approved by CEN on 2013-03-01. The start and finish of text introduced or altered by amendment is indicated in the t

8、ext by tags !“. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 4126-7 DIN EN ISO 4126-7 ISO 4135 DIN EN ISO 4135 ISO 7291 DIN EN ISO 7291 ISO 10079-3 DIN EN ISO 10079-3 ISO 14971 DIN EN ISO 14971 ISO 15001 DIN EN ISO 15001 IEC 60601-1

9、DIN EN 60601-1 (VDE 0750-1) Amendments This standard differs from DIN EN ISO 10524-3:2006-07 as follows: a) Amendment A1 has been incorporated: Subclauses 5.4.9 “Filtration” and 8.1 containing the “Information to be supplied by the manufacturer” have been revised. Previous editions DIN EN 738-3: 199

10、8-12, 2002-07 DIN EN ISO 10524-3: 2006-07 DIN EN ISO 10524-3:2013-06 3 National Annex NA (informative) Bibliography DIN EN ISO 4126-7, Safety devices for protection against excessive pressure Part 7: Common data DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 7291, Gas w

11、elding equipment Pressure regulators for manifold systems used in welding, cutting and allied processes up to 30 MPa (300 bar) DIN EN ISO 10079-3, Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source DIN EN ISO 14971, Medical devices Application o

12、f risk management to medical devices DIN EN ISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygen DIN EN EN 60601-1 (VDE 0750 Part 1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN ISO 10524-3:2013-06 4 This page is i

13、ntentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10524-3 April 2006 + A1 March 2013 ICS 11.040.10 Supersedes EN 738-3:1998 English Version Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005 + Amd 1

14、:2013) Dtendeurs pour lutilisation avec les gaz mdicaux Partie 3: Dtendeurs intgrs dans les robinets des bouteilles de gaz (ISO 10524-3:2005 + Amd 1:2013) Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in Flaschenventilen (ISO 10524- 3:2005 + Amd 1:2013) EN ISO 10524-3:

15、2006 was approved by CEN on 2006-03-20 and Amendment A1:2013 on 2013-03-01. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and biblio

16、graphical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsi

17、bility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republ

18、ic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALI

19、SATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10524-3:2006 + A1:2013 E Contents Page Foreword to EN ISO 10524:2005 . 3 Foreword t

20、o EN ISO 10524-3:2006/A1:2013 . 3 Introduction . 4 1 Scope . 5 2 Normative references 5 3 Terms and definitions 6 4 Symbols 8 5 General requirements 8 5.1 Safety . 8 5.2 Alternative construction 8 5.3 Materials 8 5.4 Design requirements 9 5.5 Constructional requirements 16 6 Test methods 17 6.1 Cond

21、itions . 17 6.2 Test methods for outlet pressure . 18 6.3 Test method for pressure-relief valve 19 6.4 Test methods for leakage 19 6.5 Test method for mechanical strength 20 6.6 Test method for resistance to ignition . 21 6.7 Test method for accuracy of flow of pressure regulators integrated with cy

22、linder valves fitted with flowmeters or flowgauges . 24 6.8 Test method for the stability of flow of pressure regulators integrated with cylinder valves fitted with flowmeters or flowgauges . 24 6.9 Test method for stability and accuracy of flow of pressure regulators integrated with cylinder valves

23、 fitted with fixed orifices 24 6.10 Test method for flow setting and loosening torques . 24 6.11 Drop test 25 6.12 Impact test 25 6.13 Test method for means of gas shut-off 26 6.14 Test method for non-return valve of filling port 26 6.15 Test method for durability of markings and colour coding . 26

24、7 Marking, colour coding, packaging 26 7.1 Marking 26 7.2 Colour coding . 27 7.3 Packaging . 27 8 * Information to be supplied by the manufacturer 28 Annex A (informative) Examples of pressure regulators integrated with cylinder valves . 30 Annex B (normative) Rationale 33 Annex C (informative) Repo

25、rted regional and national deviations of colour coding and nomenclature for medical gases . 35 Bibliography 37 Annex ZA . 38 2DIN EN ISO 10524-3:2013-06 EN ISO 10524-3:2006+A1:2013 (E) Foreword to EN ISO 10524:2005 The text of ISO 10524-3:2005 has been prepared by Technical Committee ISO/TC 121 “Ana

26、esthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 10524-3:2006 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI. This European Standard shall be given the

27、 status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2006, and conflicting national standards shall be withdrawn at the latest by October 2006. This document supersedes EN 738-3:1998. This document has been prepared under a mandate gi

28、ven to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the n

29、ational standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,

30、 Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 10524-3:2005 has been approved by CEN as EN ISO 10524-3:2006 without any modifications. !Foreword to EN ISO 10524-3:2006/A1:2013 This document (EN ISO 10524-3:2006/A1:2013) has b

31、een prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This Amendment to the European Standard EN ISO 10524:2006 shall be given the st

32、atus of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2013, and conflicting national standards shall be withdrawn at the latest by March 2016. Attention is drawn to the possibility that some of the elements of this document may be the s

33、ubject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directiv

34、e. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, C

35、roatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey an

36、d the United Kingdom. Endorsement notice The text of ISO 10524-3: 2005/Amd 1:2013 has been approved by CEN as EN ISO 10524-3:2006/A1:2013 without any modification.“ 3DIN EN ISO 10524-3:2013-06 EN ISO 10524-3:2006+A1:2013 (E) Introduction Pressure regulators integrated with cylinder valves are used t

37、o reduce high cylinder pressure to a lower pressure suitable for use with medical equipment or for delivery of gas directly to a patient. These functions cover a wide range of inlet and outlet pressures and flows which require specific design characteristics. It is important that the operating chara

38、cteristics of pressure regulators integrated with cylinder valves be specified and tested in a defined manner. A pressure regulator normally has coupled to it a device which controls the flow, such as a flow control valve or a fixed orifice. The flow can be indicated by a flowmeter or by a flowgauge

39、. It is essential that regular inspection and maintenance be undertaken to ensure that the pressure regulators continue to meet the requirements of this part of ISO 10524. This part of ISO 10524 pays particular attention to: use of suitable materials; safety (mechanical strength, leakage, safe relie

40、f of excess pressure and resistance to ignition); gas specificity; cleanliness; type testing; marking; information supplied by the manufacturer. Annex B contains rationale statements for some of the requirements of this part of ISO 10524. The clauses and subclauses marked with an asterisk (*) after

41、their number have corresponding rationale included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated into this part of ISO 10524. It is considered that knowledge of the reasons for the requirements will not only facilitate t

42、he proper application of this part of ISO 10524, but will expedite any subsequent revisions. 4DIN EN ISO 10524-3:2013-06 EN ISO 10524-3:2006+A1:2013 (E) 1 Scope 1.1 This part of ISO 10524 applies to pressure regulators integrated with cylinder valves (as defined in 3.16) intended for the administrat

43、ion of medical gases in the treatment, management, diagnostic evaluation and care of patients for use with the following medical gases: oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; air for driving surgical tools; nitrogen for

44、driving surgical tools. 1.2 * These pressure regulators integrated with cylinder valves are intended to be fitted to cylinders with nominal filling pressures up to 25 000 kPa at 15 C and can be provided with devices that control and measure the flow of the medical gas delivered. 2 Normative referenc

45、es The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 32:1977, Gas cylinders for medical use Mar

46、king for identification of content ISO 407:2004, Small medical gas cylinders Pin-index yoke-type valve connections ISO 5145, Cylinder valve outlets for gases and gas mixtures Selection and dimensioning ISO 5359:2000, Low-pressure hose assemblies for use with medical gases ISO 7396-1:2002, Medical ga

47、s pipeline systems Part 1: Pipelines for compressed medical gases and vacuum 5DIN EN ISO 10524-3:2013-06 EN ISO 10524-3:2006+A1:2013 (E) ISO/TR 7470:1988, Valve outlets for gas cylinders List of provisions which are either standardized or in use ISO 9170-1:1999, Terminal units for medical gas pipeli

48、ne systems Part 1: Terminal units for use with compressed medical gases and vacuum ISO 10297:1), Transportable gas cylinders Cylinder valves Specification and type testing ISO 10920:1997, Gas cylinders 25E taper thread for connection of valves to gas cylinders Specification EN ISO 11116-1:1999, Gas

49、cylinders 17E taper thread for connection of valves to gas cylinders Part 1: Specifications ISO 11117:1998, Gas cylinders Valve protection caps and valve guards for industrial and medical gas cylinders Design, construction and tests ISO 13341:1997, Transportable gas cylinders Fitting of valves to gas cylinders ISO 14971:2000, Medical devices Application of risk management to medical devices ISO 15001: