BS EN ISO 21969-2009 High-pressure flexible connections for use with medical gas systems《同医疗气体设备一起使用的高压挠性连接件》.pdf

1、BS EN ISO21969:2009ICS 11.040.10; 23.040.60NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDHigh-pressure flexibleconnections foruse with medicalgas systems (ISO21969:2009)Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/07/2010 07:55, Uncontrolled Copy,

2、 (c) BSIThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 March2010 BSI 2010ISBN 978 0 580 65548 7Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 21969:2009National forewordThis British Standard is the UK implementation of E

3、N ISO 21969:2009.It supersedes BS EN ISO 21969:2006 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/6, Medical gas supply systems.A list of organizations represented on this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 do

4、es 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.Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/07/2010 07:55, Uncontrolled Copy, (c) BSIEU

5、ROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21969 November 2009 ICS 11.040.10 Supersedes EN ISO 21969:2006English Version High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) Raccords flexibles haute pression pour utilisation avec les systmes de gaz mdicaux

6、 (ISO 21969:2009) Flexible Hochdruck-Verbindungen zur Verwendung in Systemen fr medizinische Gase (ISO 21969:2009) This European Standard was approved by CEN on 8 September 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

7、European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (E

8、nglish, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulga

9、ria, 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 STANDARDI

10、ZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21969:2009: ELicensed Copy: Wang Bin, ISO/EXCHANGE C

11、HINA STANDARDS, 08/07/2010 07:55, Uncontrolled Copy, (c) BSIBS EN ISO 21969:2009EN ISO 21969:2009 (E) 3 Foreword This document (EN ISO 21969:2009) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collaboration with Technical Committee CEN/TC 215 “Respira

12、tory 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 May 2010, and conflicting national standards shall be withdrawn at the late

13、st by May 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 ISO 21969:2006. This document has been pre

14、pared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal

15、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, Luxembourg, Malta,

16、Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 21969:2009 has been approved by CEN as a EN ISO 21969:2009 without any modification. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/07/

17、2010 07:55, Uncontrolled Copy, (c) BSIBS EN ISO 21969:2009EN ISO 21969:2009 (E) 4 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC This International Standard has been prepared under a mandate given to CEN by the Europea

18、n Commission and the European Free Trade Association to provide a 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 Union under that Directive and has been implemented as a nat

19、ional 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 Z

20、A.1 Correspondence between this International Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this International Standard Essential Requirements (ERs) of Directive 93/42/EEC9/EC Qualifying remarks/Notes (s) of remarks/Notes 5 1, 2, 3, 4, 5 5.1 7.1, 7.2, 7.3, 9.3 5.3.1 7.1, 7.3, 9.3 - 5.3

21、.2 7.15.3.3 3, 45.3.4 4, 55.4.1 7.5, 7.6, 9.1, 12.7.4 5.4.2 7.5, 7.6, 9.1, 12.7.4 5.4.3 4, 12.7.15.4.4 3 5.4.5 7.5, 9.35.4.6 4, 9.2, 9.3, 12.7.1 5.4.7 4, 9.2, 9.3, 12.7.1 5.4.8 7.1, 9.3 5.4.9 12.7.15.4.10 1, 2, 35.5.1 7.1, 9.1, 12.7.1 5.5.2 7.1, 7.2, 7.3, 9.3 6.2.1 7.5 7.1.1 13.1, 13.27.1.2 13.3a),

22、13.6b), 13.3d), 13.5 ER 13.3a) relating to the authorised representative is not fully addressed 7.2 13.2 7.3.1 3, 5, 7.2, 7.6 7.3.2 13.3b)8 1, 2, 5, 9.1, 13.1, 13.4, 13.6c), 13.6d),13.3i), 13.3j), 13.3k) - 13.6q) ER 13.3q) relating to the date of issue of the last instructions for use is not address

23、ed 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, 08/07/2010 07:55, Uncontrolled Copy, (c) BSIBS EN ISO 21969:2009ISO 21969:2009(E) ISO 2009 All rights reserved i

24、iiContents Page Foreword iv 1 Scope1 2 * Normative references .2 3 Terms and definitions .2 4 Terminology .3 5 General requirements .4 5.1 Safety4 5.2 Alternative construction .4 5.3 Materials .4 5.4 Design requirements.4 5.5 Constructional requirements .6 6 Test methods .6 6.1 General .6 6.2 Type t

25、ests.7 7 Marking, colour coding and packaging.9 7.1 Marking.9 7.2 Colour coding 10 7.3 Packaging.10 8 Information to be supplied by the manufacturer .10 Annex A (informative) Rationale12 Bibliography13 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/07/2010 07:55, Uncontrolled Copy, (c) BS

26、IBS EN ISO 21969:2009ISO 21969:2009(E) iv ISO 2009 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 techni

27、cal committees. Each member body interested 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 w

28、ith the International Electrotechnical 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 Int

29、ernational Standards adopted by the 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 m

30、ay be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 21969 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems. This second edition cancels and replaces the f

31、irst edition (ISO 21969:2005) which has been technically revised. Annex A contains rationale statements for some of the requirements of this International Standard. It is included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorpo

32、rated in this International Standard. The clauses and subclauses marked with an asterisk (*) after their number have corresponding rationale contained in Annex A. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this International

33、 Standard, but will also expedite any subsequent revision. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/07/2010 07:55, Uncontrolled Copy, (c) BSIBS EN ISO 21969:2009INTERNATIONAL STANDARD ISO 21969:2009(E) ISO 2009 All rights reserved 1High-pressure flexible connections for use with med

34、ical gas systems 1 Scope 1.1 This International Standard applies to high-pressure flexible connections intended to be connected to cylinders or cylinder bundles with nominal filling pressures up to 25 000 kPa at 15 C for use with the following medical gases: oxygen; nitrous oxide; air for breathing;

35、 helium; carbon dioxide; xenon; mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools; oxygen-enriched air. 1.2 This International Standard applies to high-pressure flexible connections intended to connect cylinders or cylinder bundles to manifolds w

36、ithin sources of supply of medical gas pipeline systems complying with ISO 7396-1. 1.3 This International Standard applies to high-pressure flexible connections intended to connect a cylinder to an inlet port of medical equipment (e.g. anaesthetic workstation or lung ventilator) fitted with an integ

37、ral pressure regulator complying with ISO 10524-1. 1.4 This International Standard does not apply to high-pressure flexible connections intended to be used to fill cylinders nor does it apply to low-pressure flexible hose assemblies that are covered by ISO 5359. Licensed Copy: Wang Bin, ISO/EXCHANGE

38、 CHINA STANDARDS, 08/07/2010 07:55, Uncontrolled Copy, (c) BSIBS EN ISO 21969:2009ISO 21969:2009(E) 2 ISO 2009 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.

39、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 407:2004, Small medical gas cylinders Pin-index yoke-type valve connections ISO 5145:2004, Cylinder valve out

40、lets for gases and gas mixtures Selection and dimensioning ISO 7396-1:2007, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum ISO 14971:2007, Medical devices Application of risk management to medical devices ISO 15001:2003, Anaesthetic and respiratory equi

41、pment Compatibility with oxygen 3 Terms and definitions For the purposes of this document the following terms and definitions apply. 3.1 cylinder bundle pack or pallet of cylinders linked together with one or more connectors for filling and emptying 3.2 gas-specific having characteristics which prev

42、ent connection between different gas services 3.3 manifold device for connecting the outlet(s) of one or more cylinders or cylinder bundles of the same gas to the pipeline system 3.4 medical gas any gas or mixture of gases intended for administration to patients for anaesthetic, therapeutic, diagnos

43、tic or prophylactic purposes 3.5 nominal inlet pressure P1pressure for which the high-pressure flexible connection is intended to be used NOTE P1is specified by the manufacturer. 3.6 single fault condition condition in which a single means for protection against a safety hazard in equipment is defec

44、tive or a single external abnormal condition is present NOTE This definition was taken from IEC 60601-1. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/07/2010 07:55, Uncontrolled Copy, (c) BSIBS EN ISO 21969:2009ISO 21969:2009(E) ISO 2009 All rights reserved 34 Terminology Typical exampl

45、es of high-pressure flexible connections are given in Figure 1. a) Coiled metal pipe (e.g. copper) b) Metal (e.g. copper or stainless steel) pipe connected by a swivel c) Corrugated metal (e.g. stainless steel) hose fitted with retaining straps Key 1 inlet connector 2 outlet connector 3 swivel 4 res

46、training cable 5 handle to prevent torsion Figure 1 Typical examples of high-pressure flexible connections Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/07/2010 07:55, Uncontrolled Copy, (c) BSIBS EN ISO 21969:2009ISO 21969:2009(E) 4 ISO 2009 All rights reserved5 General requirements 5.1

47、 Safety High-pressure flexible connections shall, when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, present no risks that are not reduced to an acceptable level using risk management procedures in accordance with ISO 14971 a

48、nd which are connected with their intended application, in normal condition and in single fault condition. 5.2 Alternative construction High-pressure flexible connections and components or parts thereof, using materials or having forms of construction different from those detailed in Clause 5 shall

49、be presumed to be in compliance with the safety objectives of this International Standard if it can be demonstrated that an equivalent degree of safety is obtained (i.e. compliance with requirements presumes that risks have been mitigated to acceptable levels) unless objective evidence to the contrary becomes available. Evidence that an equivalent degree of safety is obtained shall be provided by the manufacturer upon request. 5.3 Materials 5.3.1 * The materials in contact with the medical gases listed in 1.1, durin