EN ISO 10524-4-2008 en Pressure regulators for use with medical gases - Part 4 Lowpressure regulators《医用气体用压力调节器 第4部分 医疗设备用低压压力调节器［代替 CEN EN 738-4］》.pdf

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)This British Standardwas published under theauthority of the StandardsPolicy and Strat

2、egyCommittee 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 ISO10524-4:2008. It supersedes BS EN 738-4:1999 which is withdrawn.The UK participation in its pre

3、paration 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 not purport to include all the necessary provisionsof a contract. Users are responsible for its cor

4、rect application.Compliance with a British Standard cannot confer immunityfrom legal obligations.28 February EUROPEAN 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-pressu

5、re regulators (ISO 10524-4:2008)Dtendeurs pour lutilisation avec les gaz mdicaux - Partie4: Dtendeurs 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 mem

6、bers 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 and bibliographical references concerning such nationalstandards may be obtained on applicatio

7、n to the CEN 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the

8、same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Ro

9、mania, 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 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedw

10、orldwide for CEN national Members.Ref. No. EN ISO 10524-4:2008: EBS 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 2

11、15 “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 withd

12、rawn 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

13、 has 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 CE

14、N/CENELEC 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,

15、Luxembourg, 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. BS EN ISO 10524-4:2008EN ISO 10524-4:2

16、008 (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 Commission and the European Free Trade Association to provide one means of conforming to Essential Re

17、quirements 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 national standard in at least one Member State, compliance with the clauses of this standard given

18、 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 ZA.1 Correspondence between this International Standard and Directive 93/42/EEC, Medical devices

19、 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 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

20、.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 BS 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 r

21、emarks/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 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,

22、 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 7.3.3 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

23、 standard. BS 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 Desi

24、gn requirements .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 flowmet

25、ers or 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 durabi

26、lity of 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 (info

27、rmative) Reported regional and national deviations of colour coding and nomenclature for medical gases26 Annex D (informative) Environmental aspects.28 Bibliography 30 BS EN ISO 10524-4:2008ISO 10524-4:2008(E) iv ISO 2008 All rights reservedForeword ISO (the International Organization for Standardiz

28、ation) 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 has the right to be

29、 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. International Standar

30、ds 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. Publication as an Intern

31、ational 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 rights. ISO 10524-4

32、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 regulators with f

33、low-metering devices Part 2: Manifold and line pressure regulators Part 3: Pressure regulators integrated with cylinder valves Part 4: Low-pressure regulators BS 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

34、in a medical gas pipeline system to a lower pressure suitable for use with medical equipment or for delivery 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 character

35、istics of low-pressure regulators are appropriately specified for their intended use and then tested in a defined 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 flow

36、gauge. It is essential that regular inspection and maintenance are undertaken to ensure that low-pressure regulators 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

37、and resistance to ignition); suitability of materials; gas specificity; accuracy; cleanliness; 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

38、(*) after their number have corresponding rationale contained in Annex B, included to provide additional insight 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

39、not only facilitate the proper application of this part of ISO 10524, but will expedite any subsequent revisions. BS EN ISO 10524-4:2008BS EN ISO 10524-4:2008INTERNATIONAL STANDARD ISO 10524-4:2008(E) ISO 2008 All rights reserved 1Pressure regulators for use with medical gases Part 4: Low-pressure r

40、egulators 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 evaluation and care of patients: oxygen; nitrous oxide; medical air; helium; carbon dioxide; xe

41、non; 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 10524 are as follows: a) low-pressure regulators intended to be connected to terminal unit

42、s 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 with ISO 7396-1; c) low-pressure regulators intended to be connected to terminal units atta

43、ched 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 pipeline system complying with ISO 7396-1. 1.3 This part of ISO 10524 does not apply to low-

44、pressure regulators integrated within anaesthetic and respiratory equipment. BS EN ISO 10524-4:2008ISO 10524-4:2008(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 edit

45、ion cited applies. For undated references, the latest edition of the referenced document (including any amendments) 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

46、 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 pressure regulators with flow-metering devices ISO 10524-3, Pressure regulators

47、 for use with medical gases Part 3: Pressure regulators integrated with cylinder valves ISO 11114-3:1997, Transportable gas cylinders Compatibility of cylinder and valve materials with gas contents Part 3: Autogenous ignition test in oxygen atmosphere ISO 14971:2007, Medical devices Application of r

48、isk management to medical devices ISO 15001:2003, Anaesthetic and respiratory equipment Compatibility with oxygen EN 837-1, Pressure gauges Part 1: Bourdon tube pressure gauges Dimensions, metrology, requirements and testing EN 1089-3:2004, Transportable gas cylinders Gas cylinder identification (ex

49、cluding LPG) Part 3: Colour coding EN 13544-2, Respiratory therapy equipment Part 2: Tubing and connectors 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 accuracy of flow difference between the indicated value and the actual value of the flow expressed in percent 3.2 adjustable pressure regulator pressure regulator that is provided with