EN ISO 10524-2-2006 en Pressure regulators for use with medical gases - Part 2 Manifold and line pressure regulators《医用气体用压力调节器 第2部分 进气压力调节器和线性压力调节器［代替 CEN EN 738-2］》.pdf

1、BRITISH STANDARDBS EN ISO 10524-2:2006Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulatorsThe European Standard EN ISO 10524-2:2006 has the status of a British StandardICS 11.040.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g4

2、4g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 10524-2:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2007 BSI 2007ISBN 978 0 580 50112 8Natio

3、nal forewordThis British Standard was published by BSI. It is the UK implementation of EN ISO 10524-2:2006. It is identical with ISO 10524-2:2005. It supersedes BS EN 738-2:1999 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and re

4、spiratory equipment, to Subcommittee CH/121/6, Medical gas supply systems.A list of organizations represented on CH/121/6 can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applica

5、tion.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10524-2April 2006ICS 11.040.10 Supersedes EN 738-2:1998 English VersionPressure regulators for use with

6、 medical gases - Part 2:Manifold and line pressure regulators (ISO 10524-2:2005)Dtendeurs pour lutilisation avec les gaz mdicaux - Partie2: Dtendeurs de rampes et de canalisations (ISO 10524-2:2005)Druckminderer zur Verwendung mit medizinischen Gasen -Teil 2: Hauptstellendruckregler und Leitungsdruc

7、kminderer(ISO 10524-2:2005)This European Standard was approved by CEN on 20 March 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists

8、and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibil

9、ity of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy

10、, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Bru

11、ssels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10524-2:2006: EForeword The text of ISO 10524-2:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Orga

12、nization for Standardization (ISO) and has been taken over as EN ISO 10524-2:2006 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 status of a national standard, either by publication of an i

13、dentical 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 738-2: 1998. This document has been prepared under a mandate given to CEN by the European Commission and the European Free

14、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 national standards organizations of the following countries a

15、re 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, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switz

16、erland and United Kingdom. Endorsement notice The text of ISO 10524-2:2005 has been approved by CEN as EN ISO 10524-2:2006 without any modifications. EN ISO 10524-2:2006Reference numberISO 10524-2:2005(E)INTERNATIONAL STANDARD ISO10524-2First edition2005-05-01Pressure regulators for use with medical

17、 gases Part 2: Manifold and line pressure regulators Dtendeurs pour lutilisation avec les gaz mdicaux Partie 2: Dtendeurs de rampes et de canalisations EN ISO 10524-2:2006ii iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 Symbols . 4 5 Ge

18、neral requirements . 4 5.1 Safety 4 5.2 Alternative construction. 4 5.3 Materials. 4 5.4 Design requirements 5 5.5 Constructional requirements. 9 6 Test methods. 9 6.1 Conditions 9 6.2 Test methods for manifold pressure regulators 10 6.3 Test methods for line pressure regulators.16 6.4 Test method f

19、or determination of the auto-ignition temperature of sealing materials and lubricants . 17 6.5 Test method for durability of markings and colour coding 18 7 Marking, colour coding, packaging. 19 7.1 Marking. 19 7.2 Colour coding 20 7.3 Packaging 21 8 Information to be supplied by the manufacturer .

20、21 Annex A (informative) Examples of pressure regulators . 22 Annex B (informative) Rationale .24 Annex C (informative) Reported regional and national deviations of colour coding and nomenclature for medical gases . 26 Bibliography . 28 EN ISO 10524-2:2006iv Foreword ISO (the International Organizat

21、ion for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established h

22、as the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Int

23、ernational Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Public

24、ation as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent ri

25、ghts. ISO 10524-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems. ISO 10524 consists of the following parts, under the general title Pressure regulators for use with medical gases: Part 1: Pressure regulators and pressure

26、 regulators with flow-metering devices Part 2: Manifold and line pressure regulators Part 3: Pressure regulators integrated with cylinder valves Part 4: Low-pressure regulators EN ISO 10524-2:2006vIntroduction Manifold pressure regulators are used to reduce cylinder pressure to a lower pressure with

27、in a source of supply of a medical gas pipeline system. Line pressure regulators are used to reduce the pressure supplied by manifold pressure regulators or by cryogenic vessels to the lower pressure required at the terminal units of medical gas pipeline systems. These functions cover a wide range o

28、f inlet and outlet pressures and flows which require specific design characteristics. It is important that the operating characteristics of manifold and line pressure regulators are specified and tested in a defined manner. It is essential that regular inspection and maintenance be undertaken to ens

29、ure 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 relief of excess pressure and resistance to ignition); cleanliness; type testing; m

30、arking; 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 their number have corresponding rationale included to provide additional insight into the reaso

31、ning 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 the proper application of this part of ISO 10524, but will expedite any subsequent revisions. EN

32、 ISO 10524-2:2006blank1Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators 1 Scope 1.1* This part of ISO 10524 specifies requirements for manifold pressure regulators (as defined in 3.6) intended to be connected to cylinders with nominal filling pressures up

33、to 25 000 kPa at 15 C and for line pressure regulators (as defined in 3.4) for inlet pressures up to 3 000 kPa and intended for use in pipeline systems for the following medical gases: oxygen; nitrous oxide; air for breathing; carbon dioxide; oxygen/nitrous oxide mixtures; air for driving surgical t

34、ools; nitrogen for driving surgical tools; oxygen produced by an oxygen concentrator. 1.2* This part of ISO 10524 applies to manifold pressure regulators and line pressure regulators supplied as individual units or to the relevant components incorporated within an assembly. 1.3 This part of ISO 1052

35、4 does not apply to pressure regulators for use with vacuum pipeline systems. NOTE Requirements for pressure regulators for use with vacuum pipeline systems are covered in ISO 10079-3. 2 Normative references The following referenced documents are indispensable for the application of this document. F

36、or 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 Marking for identification of content ISO 7396-1:2002, Medical gas pipeline systems Part 1: Pipeli

37、nes for compressed medical gases and vacuum ISO 14971:2000, Medical devices Application of risk management to medical devices ISO 15001:2003, Anaesthetic and respiratory equipment Compatibility with oxygen EN ISO 10524-2:20062 EN 837-1:1996, Pressure gauges Part 1: Bourdon tube pressure gauges Dimen

38、sions, metrology, requirements and testing 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 closure pressure P4stabilized outlet pressure, after cessation of the flow, from a pressure regulator when the flow has been set to standard discharge

39、3.2 double-stage pipeline distribution system pipeline distribution system in which gas is initially distributed from the supply system at a higher pressure than the nominal distribution pressure NOTE This higher pressure (nominal supply system pressure) is then reduced to the nominal distribution p

40、ressure by additional line pressure regulators. 3.3 flow characteristic variation of outlet pressure in relation to flow with the inlet pressure remaining constant 3.4 line pressure regulator pressure regulator intended to be installed within a medical gas pipeline system downstream of a manifold pr

41、essure regulator or cryogenic gas supply system 3.5 manifold device for connecting the outlet(s) of one or more cylinders or cylinder bundles of the same medical gas to a pipeline system 3.6 manifold pressure regulator pressure regulator intended to be installed within sources of supply containing c

42、ylinders or cylinder bundles 3.7 medical gas pipeline system complete system which comprises a supply system, a monitoring and alarm system, a pipeline distribution system with terminal units at the points where medical gases or vacuum may be required 3.8 nominal distribution pressure pressure of ga

43、s which the pipeline system is intended to deliver at the terminal units 3.9 nominal inlet pressure P1upstream pressure (specified as a single value by the manufacturer) for which the pressure regulator is intended to be used NOTE P1for manifold pressure regulators is the maximum cylinder filling pr

44、essure at 15 C. EN ISO 10524-2:200633.10 nominal outlet pressure P2downstream pressure for the standard discharge, Q1, specified by the manufacturer 3.11 pressure characteristic variation of the outlet pressure in relation to inlet pressure under constant flow conditions 3.12 pressure gauge device t

45、hat measures and indicates pressure 3.13 pressure regulator device that reduces the inlet pressure and maintains the set outlet pressure within specified limits 3.14 pressure-relief valve device intended to relieve excess pressure at a pre-set value 3.15 single-fault condition condition in which a s

46、ingle means for protection against a safety hazard in equipment is defective or a single external abnormal condition is present IEC 60601-1:1988, 2.10.11 3.16 single-stage pipeline distribution system pipeline distribution system in which gas is distributed from the supply system at the nominal dist

47、ribution pressure 3.17 source of supply that portion of the supply system with associated control equipment, which supplies the pipeline distribution system 3.18 standard discharge Q1flow for which the pressure regulator is designed to maintain a nominal outlet pressure, P2, at test inlet pressure,

48、P33.19 supply system system that supplies the pipeline distribution system and which includes two or more sources of supply 3.20 test inlet pressure P3minimum inlet test pressure NOTE See Table 1. EN ISO 10524-2:20064 3.21 test outlet pressure P5highest or lowest value of the outlet pressure resulti

49、ng from a variation in the inlet pressure between P1and P3at previously adjusted conditions P1, P2, Q14 Symbols The symbols used for the functional characteristics are given in Table 1. Table 1 Symbols P1Nominal inlet pressure P2Nominal outlet pressure P3Test inlet pressure P4Closure pressure P5Test outlet pressure Q1Standard discharge R Coefficient of pressure increase upon closure i Irregularity coefficient NOTE P3= 2P2+ 100 kPa Examples of a line pressure regulator and a manifold pressure regulator with termino