EN ISO 21969-2009 en 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

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

2、mmittee 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forewordThis British Standard is the UK implementation of EN ISO 21969:2009.It supersedes BS EN ISO 21969:2006 which is withdrawn.The UK participation in its

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

4、correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN 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 syste

5、ms (ISO 21969:2009) Raccords flexibles haute pression pour utilisation avec les systmes de gaz mdicaux (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 bou

6、nd 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 bibliographical references concerning such national standards may be obtained on application to the C

7、EN 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 responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same sta

8、tus as the official 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, Romani

9、a, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION 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 wo

10、rldwide for CEN national Members. Ref. No. EN ISO 21969:2009: EBS 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 “Resp

11、iratory 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 l

12、atest 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

13、prepared 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 Intern

14、al 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, Malt

15、a, 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. BS EN ISO 21969:2009EN ISO 21969:2009 (E) 4 Annex ZA (info

16、rmative) 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 European Commission and the European Free Trade Association to provide a means of conforming to Essenti

17、al 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 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 Clause(s)/sub-cla

19、use(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 - 5.3.2 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.

20、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), 13.6b), 13.3d), 13.5 ER 13.3a) relating to the authorised representative is not fully addressed

21、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 addressed WARNING Other requirements and other EU Directives may be applicable to the product(s) fallin

22、g within the scope of this standard. BS EN ISO 21969:2009ISO 21969:2009(E) ISO 2009 All rights reserved iiiContents 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

23、 5.4 Design requirements.4 5.5 Constructional requirements .6 6 Test methods .6 6.1 General .6 6.2 Type tests.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 Bibliogr

24、aphy13 BS 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

25、technical 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 clo

26、sely with 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. Dra

27、ft International 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 docu

28、ment may 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

29、 the first 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 i

30、ncorporated 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 Interna

31、tional Standard, but will also expedite any subsequent revision. BS EN ISO 21969:2009INTERNATIONAL STANDARD ISO 21969:2009(E) ISO 2009 All rights reserved 1High-pressure flexible connections for use with medical gas systems 1 Scope 1.1 This International Standard applies to high-pressure flexible co

32、nnections 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; helium; carbon dioxide; xenon; mixtures of the gases listed above; air for driving surgical

33、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 within sources of supply of medical gas pipeline systems complying with ISO 7396-1. 1.3 This I

34、nternational 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 integral pressure regulator complying with ISO 10524-1. 1.4 This International Standard does not a

35、pply 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. BS EN ISO 21969:2009ISO 21969:2009(E) 2 ISO 2009 All rights reserved2 * Normative references The following referenced documents ar

36、e 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 Marking for identification of content ISO 4

37、07:2004, Small medical gas cylinders Pin-index yoke-type valve connections ISO 5145:2004, Cylinder valve outlets 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, Medica

38、l devices Application of risk management to medical devices ISO 15001:2003, Anaesthetic and respiratory equipment 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 toge

39、ther with one or more connectors for filling and emptying 3.2 gas-specific having characteristics which prevent 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 g

40、as any gas or mixture of gases intended for administration to patients for anaesthetic, therapeutic, diagnostic 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 fa

41、ult condition condition in which a single means for protection against a safety hazard in equipment is defective or a single external abnormal condition is present NOTE This definition was taken from IEC 60601-1. BS EN ISO 21969:2009ISO 21969:2009(E) ISO 2009 All rights reserved 34 Terminology Typic

42、al examples 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 swi

43、vel 4 restraining cable 5 handle to prevent torsion Figure 1 Typical examples of high-pressure flexible connections BS EN ISO 21969:2009ISO 21969:2009(E) 4 ISO 2009 All rights reserved5 General requirements 5.1 Safety High-pressure flexible connections shall, when transported, stored, installed, ope

44、rated 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 and which are connected with their intended application, in normal condition and in single

45、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 be presumed to be in compliance with the safety objectives of this International Standard

46、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 pr

47、ovided by the manufacturer upon request. 5.3 Materials 5.3.1 * The materials in contact with the medical gases listed in 1.1, during normal use shall be resistant to corrosion and compatible with oxygen, with the other medical gases and with their mixtures in the temperature range specified in 5.3.3

48、. NOTE 1 Corrosion resistance includes resistance against moisture and surrounding materials. NOTE 2 Compatibility with oxygen involves both combustibility and ease of ignition. Materials that burn in air will burn violently in pure oxygen. Many materials that do not burn in air will do so in pure o

49、xygen, particularly under pressure. Similarly, materials that can be ignited in air require lower ignition energies for ignition in oxygen. Many such materials can be ignited by friction at a valve seat or by adiabatic compression produced when oxygen at high pressure is rapidly introduced into a system initially at low pressure. NOTE 3 Criteria for the selection of metallic and non-metallic materials are given in ISO 15001. 5.3.2 * Non-metallic (e.g. polymer-lined or rubber-reinforced) flexible hoses shall not be u