1、BS EN ISO10524-4:2008ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPressure regulators foruse with medical gasesPart 4: Low-pressure regulators (ISO10524-4:2008)Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 04/06/2009 08:05, Uncontrolled
2、Copy, (c) BSIThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 2009 BSI 2009ISBN 978 0 580 65929 4Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 10524-4:2008National forewordThis British Standard is the UK implementation of EN
3、 ISO10524-4:2008. It supersedes BS EN 738-4:1999 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/6, Medical gas supply systems.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does
4、not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.28 February Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 04/06/2009 08:05, Uncontrolled Copy,
5、(c) BSIEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10524-4June 2008ICS 11.040.10 Supersedes EN 738-4:1998 English VersionPressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)Dtendeurs pour lutilisation avec les gaz mdicaux - Partie4: Dtendeurs
6、basse pression (ISO 10524-4:2008)Druckminderer zur Verwendung mit medizinischen Gasen -Teil 4: Niederdruckminderer (ISO 10524-4:2008)This European Standard was approved by CEN on 29 May 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
7、giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official ve
8、rsions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium,
9、 Bulgaria, 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, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDA
10、RDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10524-4:2008: ELicensed Copy: Wang Bin, ISO/EXCHANGE
11、 CHINA STANDARDS, 04/06/2009 08:05, Uncontrolled Copy, (c) BSIBS EN ISO 10524-4:2008EN ISO 10524-4:2008 (E) 3 Foreword This document (EN ISO 10524-4:2008) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collaboration with Technical Committee CEN/TC 215
12、“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 identical text or by endorsement, at the latest by December 2008, and conflicting national standards shall be withdraw
13、n at the latest by June 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 738-4:1998. This document ha
14、s been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive(s). For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/C
15、ENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Lux
16、embourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10524-4:2008 has been approved by CEN as a EN ISO 10524-4:2008 without any modification. Licensed Copy: Wang Bin, ISO/EXCHANGE CHI
17、NA STANDARDS, 04/06/2009 08:05, Uncontrolled Copy, (c) BSIBS EN ISO 10524-4:2008EN ISO 10524-4:2008 (E) 4 Annex ZA (informative) Correspondence between this International Standard and Directive 93/42/EEC This International Standard has been prepared under a mandate given to CEN by the European Commi
18、ssion and the European Free Trade Association to provide one means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on Medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a na
19、tional standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table
20、ZA.1 Correspondence between this International Standard and Directive 93/42/EEC, Medical devices Clause(s)/Subclause(s) of this International Standard Essential Requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 5 1 5.1 2 - 6 5.1.2 9.1 - 12.7.4 5.2 2 5.3 2 5.3.1 7.1 7.3 9.3 5.3.2
21、7.3 9.3 5.3.3 4 7.1 9.2 5.3.4 3 5 5.3.5 7.1 7.2 5.4 2 3 4 5.4.1 9.2 5.4.2.1 10.2 10.3 5.4.2.3 10.2 5.4.3 9.1 12.7.4 5.4.4 9.1 12.7. 5.4.6 12.7.1 5.4.7 7.2 7.6 5.4.8 7.5 5.4.9 7.5 9.2 12.7.1 5.4.10.1 12.8.1 12.8.2 5.4.10.2 10.2 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 04/06/2009 08:05,
22、Uncontrolled Copy, (c) BSIBS EN ISO 10524-4:2008EN ISO 10524-4:2008 (E) 5 Clause(s)/Subclause(s) of this International Standard Essential Requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 5.4.10.3 10.1 12.8.1 12.8.2 5.4.10.4 10.1 12.8.1 12.8.2 5.4.10.5 12.8.1 12.8.2 5.4.11.1 10.1
23、 10.3 12.8.1 12.8.2 5.4.11.2 10.1 12.8.1 12.8.2 5.4.11.3 10.1 12.8.1 12.8.2 5.4.12 10.1 12.8.1 12.8.2 5.5.1 7.2 9.3 5.5.2 9.3 6 7.5 9.2 9.3 12.8.1 12.8.2 7.1 13.1 13.2 7.1.2, 1st dash 13.1 7.1.2, 2nddash 13.1 7.1.2, 3rddash 13.3 d) 7.1.4, 1stdash 13.1 7.1.6 12.9 7.2 13.2 7.3 3 - 5 7.3.1 5 7.2 7.6 7.
24、3.3 13.1 13.3 b) 8.1 and 8.2 13.1 13.3 a) 13.4 13.6 a) 8.3 9.1 9.3 13.6 l) WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 04/06/2009 08:05, Uncontrolled Copy, (c
25、) BSIBS EN ISO 10524-4:2008ISO 10524-4:2008(E) ISO 2008 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope 1 2 * Normative references2 3 Terms and definitions .2 4 Nomenclature.4 5 General requirements4 5.1 Safety 4 5.2 Alternative construction .4 5.3 Materials .5 5.4 Design req
26、uirements .5 5.5 Constructional requirements12 6 Test methods13 6.1 General13 6.2 Test conditions 13 6.3 Test method for outlet pressure.13 6.4 Test methods for leakage .14 6.5 Test method for mechanical strength15 6.6 Test method for accuracy of flow of pressure regulators fitted with flowmeters or
27、 flowgauges .15 6.7 Test method for the stability of flow of pressure regulators fitted with flowmeters or flowgauges .15 6.8 Test method for stability and accuracy of flow of pressure regulators fitted with fixed orifices 15 6.9 Test method for loosening torque .15 6.10 Test method for durability o
28、f markings and colour coding 15 7 Marking, colour coding, packaging .16 7.1 Marking .16 7.2 Colour coding.17 7.3 Packaging .17 8 Information to be supplied by the manufacturer17 Annex A (informative) Typical examples of low-pressure regulators19 Annex B (informative) Rationale 24 Annex C (informativ
29、e) Reported regional and national deviations of colour coding and nomenclature for medical gases26 Annex D (informative) Environmental aspects.28 Bibliography 30 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 04/06/2009 08:05, Uncontrolled Copy, (c) BSIBS EN ISO 10524-4:2008ISO 10524-4:2008(
30、E) iv ISO 2008 All rights reservedForeword ISO (the International Organization 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 int
31、erested in a subject for which a technical committee has been established has 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 Electrotechnic
32、al Commission (IEC) on all matters of electrotechnical standardization. International 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
33、technical committees are circulated to the member bodies for voting. Publication 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.
34、ISO shall not be held responsible for identifying any or all such patent rights. ISO 10524-4 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 regu
35、lators for use with medical gases: Part 1: Pressure regulators and pressure 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 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STAN
36、DARDS, 04/06/2009 08:05, Uncontrolled Copy, (c) BSIBS EN ISO 10524-4:2008ISO 10524-4:2008(E) ISO 2008 All rights reserved vIntroduction A low-pressure regulator is used to reduce the pressure in a medical gas pipeline system to a lower pressure suitable for use with medical equipment or for delivery
37、 of gas directly to a patient. These functions cover a range of inlet and outlet pressures and flows which require specific design characteristics. It is important that the operating characteristics of low-pressure regulators are appropriately specified for their intended use and then tested in a de
38、fined manner. A low-pressure regulator may be coupled to a device that 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. It is essential that regular inspection and maintenance are undertaken to ensure that low-pressure re
39、gulators continue to meet the requirements of this part of ISO 10524. This part of ISO 10524 pays particular attention to: safety (mechanical strength, leakage, safe relief of excess pressure and resistance to ignition); suitability of materials; gas specificity; accuracy; cleanliness; testing; mark
40、ing; 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 contained in Annex B, included to provide additional ins
41、ight into the reasoning that led to the requirements and recommendations that have been incorporated in this document. 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 revis
42、ions. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 04/06/2009 08:05, Uncontrolled Copy, (c) BSIBS EN ISO 10524-4:2008Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 04/06/2009 08:05, Uncontrolled Copy, (c) BSIBS EN ISO 10524-4:2008INTERNATIONAL STANDARD ISO 10524-4:2008(E) ISO 2008
43、All rights reserved 1Pressure regulators for use with medical gases Part 4: Low-pressure regulators 1 Scope 1.1 This part of ISO 10524 applies to the types of low-pressure regulators listed in 1.2 and intended to be used with the following medical gases in the treatment, management, diagnostic evalu
44、ation and care of patients: oxygen; nitrous oxide; medical air; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools; oxygen-enriched air. 1.2 The types of low-pressure regulators covered by this part of ISO
45、10524 are as follows: a) low-pressure regulators intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1; b) low-pressure regulators with integral flow-metering devices intended to be connected to terminal units of medical gas pipeline systems complying w
46、ith ISO 7396-1; c) low-pressure regulators intended to be connected to terminal units attached to pressure regulators complying with ISO 10524-1 or ISO 10524-3; d) operator-adjustable low-pressure regulators for air or nitrogen for driving surgical tools that are an integral part of a medical gas pi
47、peline system complying with ISO 7396-1. 1.3 This part of ISO 10524 does not apply to low-pressure regulators integrated within anaesthetic and respiratory equipment. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 04/06/2009 08:05, Uncontrolled Copy, (c) BSIBS EN ISO 10524-4:2008ISO 10524-4:
48、2008(E) 2 ISO 2008 All rights reserved2 * Normative references 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 amendme
49、nts) applies. ISO 5359, Low-pressure hose assemblies for use with medical gases ISO 7396-1, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum ISO 9170-1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum ISO 10524-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressur
