EN ISO 7396-1-2016 en Medical gas pipeline systems - Part 1 Pipeline systems for compressed medical gases and vacuum《医疗气体管道系统第1部分 压缩医用气体和真空管道系统(ISO 7396-1 2016)》.pdf

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1、BSI Standards PublicationBS EN ISO 7396-1:2016Medical gas pipeline systemsPart 1: Pipeline systems for compressedmedical gases and vacuumBS EN ISO 7396-1:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 7396-1:2016. It supersedes BS EN ISO 7396-1:2007+A3

2、:2013 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/121/6, Medical gas supply systems.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary

3、provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 77265 8 ICS 11.040.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was p

4、ublished under the authority of the Standards Policy and Strategy Committee on 31 March 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7396-1 March 2016 ICS 11.040.10 Supersedes EN ISO 7396-1:2007English Version

5、 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)Systmes de distribution de gaz mdicaux - Partie 1: Systmes de distribution de gaz mdicaux comprims et de vide (ISO 7396-1:2016) Rohrleitungssysteme fr medizinische Gase - Teil 1: Rohrlei

6、tungssysteme fr medizinische Druckgase und Vakuum (ISO 7396-1:2016) This European Standard was approved by CEN on 7 November 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national stand

7、ard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in an

8、y other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Repu

9、blic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN

10、 COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7396-1:2016 EBS

11、EN ISO 7396-1:2016EN ISO 7396-1:2016 (E) 3 European foreword This document (EN ISO 7396-1:2016) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of

12、 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 September 2016, and conflicting national standards shall be withdrawn at the latest by March 2019. Attention is drawn to the

13、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 7396-1:2007. This document has been prepared under a mandate given to CEN by the

14、 European Commission and the European Free 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

15、 organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemb

16、ourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 7396-1:2016 has been approved by CEN as EN ISO 7396-1:2016 without any modification. BS EN ISO 7396-1:2016EN ISO 7396-1:2016

17、(E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide one

18、 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 national standard in at least one Member State, compliance with the

19、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 ZA.1 Correspondence between this European Standard and Directive 9

20、3/42/EEC, Medical devices Clause(s)/Sub-clause(s) of this European Standard Essential Requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 4 1, 2, 7.1, 7.3 4.3.2 9.3 4.3.3 7.1 4.3.4 9.2, 9.3, 12.7.1 4.3.5 9.3 4.3.6 7.1, 9.3, 12.7.1 4.3.7 7.2, 7.6 4.3.8 9.2 4.4.1 2, 3 4.4.2 1, 2, 3,

21、4 5.1 to 5.2.9 1, 2, 3, 4, 7.6, 12.8.1, 12.8.2 5.3.1 to 5.3.3 2, 3, 7.6 5.3.4 7, 12.7.1 5.3.5 7, 12.7.1 5.3.6 7.1, 9.3 5.3.7 2, 3 5.4 3 5.5.1 3, 12.8 5.5.2.1 to 5.5.2.11 3, 7.2, 12.8 5.5.2.12 7.6 5.5.2.13 3, 9.2 5.5.2.14 12.7.2 5.5.2.15 3, 7.2 5.5.3 3, 7.2, 7.6, 12.8 BS EN ISO 7396-1:2016EN ISO 7396

22、-1:2016 (E) 5 5.6 2, 3, 7.2, 7.3, 7.6, 9.3, 12.8 5.7.1 to 5.7.7 3, 8.1, 12.8.1 5.7.8 to 5.7.9 7,6, 8.1 5.7.10 12.7.2 5.7.11 7.2 5.7.12 3, 7.2, 7.6 5.7.13 3, 9.3 5.7.14 3, 9.3 5.7.15 3, 12.8 5.8 to 5.10 2, 3 6 1, 2, 3, 4, 12.3, 12.8.1, 12.8.2, 12.9 7 1, 2, 3 7.1 9.3, 12.7.1 7.2.1 to 7.2.4 2, 3 7.2.5

23、9.2 7.2.6 9.2 7.3 2,3,4 7.4 2, 3, 12.8 8 1, 2 9 9.1, 12.7.4, 13.6 c) 9.3 9.2, 12.5, 12.6 10 13.2 11 1, 2, 3, 4, 9 11.1.5 12.6 12.1 to 12.4 1, 2, 3 12.5.1 9.3, 12.7.1, 9.2 12.5.2 7.5, 9.3, 12.7.1, 9.2 12.6.1 7.5, 12.7.1 12.6.2 to 12.6.9 2, 3, 7.5, 12.8 12.6.10 7.2 12.6.11 7.2 12.6.12 7.2 12.6.13 7.2

24、12.6.14 7.2 12.6.15 to 12.6.16 12.7.4, 12.8.1 13 4, 13.1, 13.3, 13.6 c), 13.6 d), 13.6 e), 13.6 k), 13.6 l), 13.6 m), 13.6 n), 13.6 q) WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard. BS EN ISO 7396-1:2016ISO 7396-1:2016

25、(E)Foreword viIntroduction vii1 (*) Scope 12 Normative references 23 Terms and definitions . 34 General requirements . 94.1 (*) Safety . 94.2 (*) Alternative construction . 104.3 Materials 104.4 System design 124.4.1 General. 124.4.2 Extensions and modifications of existing pipeline systems 125 Supp

26、ly systems 135.1 System components . 135.2 General requirements 135.2.1 Capacity and storage .135.2.2 Continuity of supply .135.2.3 Primary source of supply. 145.2.4 Secondary source of supply . 145.2.5 Reserve source(s) of supply 145.2.6 Means of pressure relief . 155.2.7 Maintenance supply assembl

27、y 155.2.8 Pressure regulators 165.2.9 (*)Ozone Sterilizers 165.3 Supply systems with cylinders, cylinder bundles or high-pressure reservoir(s) .165.4 Supply systems with cryogenic or non-cryogenic vessels 165.5 Supply systems for air 175.5.1 General requirements .175.5.2 Supply systems with air comp

28、ressor(s) .185.5.3 Supply systems with proportioning unit(s) 215.6 Supply systems with oxygen concentrator(s) . 235.6.1 General requirements .235.6.2 Primary source of supply. 235.6.3 Secondary source of supply . 235.6.4 Reserve source of supply . 245.6.5 Specifications for oxygen 93 . 245.6.6 Oxyge

29、n concentrator unit 255.6.7 Oxygen 93 reservoirs 255.6.8 Oxygen analysers 255.6.9 Local filling of permanently attached high-pressure reservoir(s), acting as reserve source of supply 265.7 Supply systems for vacuum . 275.8 Location of supply systems . 285.9 Location of cylinder manifolds . 285.10 Lo

30、cation of stationary cryogenic vessels . 296 Monitoring and alarm systems .296.1 General 296.2 Installation requirements . 296.3 Monitoring and alarm signals . 306.3.1 General. 306.3.2 Auditory signals .306.3.3 Visual signals 30 ISO 2016 All rights reserved iiiContents PageBS EN ISO 7396-1:2016ISO 7

31、396-1:2016(E)6.3.4 Emergency and operating alarm characteristics 306.3.5 Information signals .316.3.6 Remote alarm extensions 316.4 Provision of operating alarms . 316.5 Provision of emergency clinical alarms 326.6 (*) Provision of emergency operating alarms . 327 Pipeline distribution systems 337.1

32、 Mechanical resistance 337.2 Distribution pressure . 337.3 Low-pressure hose assemblies and low-pressure flexible connections 347.4 Double-stage pipeline distribution systems .358 Shut-off valves 358.1 General 358.2 Service shut-off valves . 368.3 Area shut-off valves 369 Terminal units, gas-specifi

33、c connectors, medical supply units, pressure regulators and pressure gauges 3810 Marking and colour coding .3810.1 Marking 3810.2 Colour coding 3811 Pipeline installation .3911.1 General 3911.2 Pipeline supports . 4011.3 Pipeline joints . 4011.4 Extensions and modifications of existing pipeline syst

34、ems 4112 Testing and commissioning 4112.1 General 4112.2 General requirements for tests 4212.3 Inspections and checks before concealment 4212.4 Tests, checks and procedures before use of the system .4212.5 Requirements for inspections and checks before concealment 4312.5.1 Inspection of marking and

35、pipeline supports4312.5.2 Check for compliance with design specifications .4312.6 Requirements for tests, checks and procedures before use of the system .4312.6.1 General. 4312.6.2 (*) Tests of area shut-off valves for leakage and closure and checks for correct zoning and correct identification 4512

36、.6.3 Test for cross-connection 4512.6.4 Test for obstruction and flow . 4612.6.5 Checks of terminal units and NIST, DISS or SIS connectors for mechanical function, gas specificity and identification .4712.6.6 Tests or checks of system performance 4712.6.7 (*) Tests of pressure-relief valves . 4712.6

37、.8 Tests of all sources of supply 4812.6.9 Tests of monitoring and alarm systems 4812.6.10 Test for particulate contamination of pipeline distribution systems 4812.6.11 Tests of the quality of medical air produced by supply systems with air compressor(s) .4912.6.12 Tests of the quality of air for dr

38、iving surgical tools produced by supply systems with air compressor(s) 4912.6.13 Tests of the quality of medical air produced by supply systems with proportioning unit(s) 4912.6.14 Tests of the quality of oxygen 93 produced by supply systems with oxygen concentrator(s) . 4912.6.15 Filling with speci

39、fic gas . 49iv ISO 2016 All rights reservedBS EN ISO 7396-1:2016ISO 7396-1:2016(E)12.6.16 Tests of gas identity 4912.6.17 Verification of restart after power supply failure .5012.7 Statement of compliance to this part of ISO 7396 .5013 Information to be supplied by the manufacturer 5013.1 General 50

40、13.2 Instructions for installation 5013.3 Instructions for use 5013.4 Operational management information . 5113.5 “As-installed” drawings . 5213.6 Electrical diagrams . 52Annex A (informative) Schematic representations of typical supply systems and area distribution systems 53Annex B (informative) G

41、uidelines for location of cylinder manifolds, cylinder storage areas and stationary vessels for cryogenic or non-cryogenic liquids 84Annex C (informative) Example of procedure for testing and commissioning 85Annex D (informative) Typical forms for documenting compliance of the pipeline systems for c

42、ompressed medical gas and vacuum 98Annex E (informative) Temperature and pressure relationships . 128Annex F (informative) Risk management checklist . 130Annex G (informative) Operational management 147Annex H (informative) Rationale . 167Annex I (informative) Rationale for compressor hazards . 170A

43、nnex J (informative) Considerations for implementation and use of oxygen 93 .171Annex K (informative) Manufacture of medical gases on site, Responsibility for medical gas quality. 173Bibliography . 176 ISO 2016 All rights reserved vBS EN ISO 7396-1:2016ISO 7396-1:2016(E)ForewordISO (the Internationa

44、l 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 interested in a subject for which a technical committee has been es

45、tablished 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 Electrotechnical Commission (IEC) on all matters of electrotechnical standardi

46、zation.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance w

47、ith the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).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. Details of any

48、 patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

49、For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems.This third edition cancels and replaces the second edition (ISO 7396-1:2007) and ISO 10083:2006, which have been technically revised. It also incorporates the Am