BS EN ISO 7396-1-2016 Medical gas pipeline systems Pipeline systems for compressed medical gases and vacuum《医用气体管道系统 压缩医用气体和真空用管道系统》.pdf

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1、BSI Standards Publication BS EN ISO 7396-1:2016 Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuumBS EN ISO 7396-1:2016 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN ISO 7396-1:2016. It supersedes BS EN ISO 7396-1:2

2、007+A3:2013 which is withdrawn.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 n

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

4、andard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2016. Amendments/corrigenda issued since publication Date 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 7396-1:2007

5、English Version 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 -

6、 Teil 1: Rohrleitungssysteme 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

7、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-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German).

8、 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-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cy

9、prus, Czech Republic, 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 K

10、ingdom. EUROPEAN 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

11、7396-1:2016 EBS EN ISO 7396-1:2016 EN 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”, t

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 September 2016, and conflicting national standards shall be withdrawn at the latest by March 2019.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

13、 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 7396-1:2007. This document has been prepared under a mandate gi

14、ven to CEN by the 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 n

15、ational standards 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,

16、Lithuania, Luxembourg, 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 7396-1:2016 E

17、N ISO 7396-1:2016 (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 Associat

18、ion 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 Union under that Directive and has been implemented as a national standard in at least one Member State, co

19、mpliance 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 ZA.1 Correspondence between this European Standa

20、rd and Directive 93/42/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,

21、 3 4.4.2 1, 2, 3, 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

22、-1:2016 EN ISO 7396-1:2016 (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 t

23、o 7.2.4 2, 3 7.2.5 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.

24、12 7.2 12.6.13 7.2 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:

25、2016ISO 7396-1:2016(E)Foreword vi Introduction vii 1 (*) Scope 1 2 Normative references 2 3 T erms and definitions . 3 4 General requirements . 9 4.1 (*) Safety . 9 4.2 (*) Alternative construction .10 4.3 Materials 10 4.4 System design12 4.4.1 General.12 4.4.2 Extensions and modifications of existi

26、ng pipeline systems 12 5 Supply systems 13 5.1 System components .13 5.2 General requirements 13 5.2.1 Capacity and storage .13 5.2.2 Continuity of supply .13 5.2.3 Primary source of supply.14 5.2.4 Secondary source of supply .14 5.2.5 Reserve source(s) of supply 14 5.2.6 Means of pressure relief .1

27、5 5.2.7 Maintenance supply assembly 15 5.2.8 Pressure regulators 16 5.2.9 (*)Ozone Sterilizers 16 5.3 Supply systems with cylinders, cylinder bundles or high-pressure reservoir(s) .16 5.4 Supply systems with cryogenic or non-cryogenic vessels 16 5.5 Supply systems for air 17 5.5.1 General requiremen

28、ts .17 5.5.2 Supply systems with air compressor(s) .18 5.5.3 Supply systems with proportioning unit(s) 21 5.6 Supply systems with oxygen concentrator(s) .23 5.6.1 General requirements .23 5.6.2 Primary source of supply.23 5.6.3 Secondary source of supply .23 5.6.4 Reserve source of supply .24 5.6.5

29、Specifications for oxygen 93 .24 5.6.6 Oxygen concentrator unit 25 5.6.7 Oxygen 93 reservoirs 25 5.6.8 Oxygen analysers 25 5.6.9 Local filling of permanently attached high-pressure reservoir(s), acting as reserve source of supply 26 5.7 Supply systems for vacuum .27 5.8 Location of supply systems .2

30、8 5.9 Location of cylinder manifolds .28 5.10 Location of stationary cryogenic vessels .29 6 Monitoring and alarm systems .29 6.1 General 29 6.2 Installation requirements .29 6.3 Monitoring and alarm signals .30 6.3.1 General.30 6.3.2 Auditory signals .30 6.3.3 Visual signals 30 ISO 2016 All rights

31、reserved iii Contents PageBS EN ISO 7396-1:2016ISO 7396-1:2016(E)6.3.4 Emergency and operating alarm characteristics 30 6.3.5 Information signals .31 6.3.6 Remote alarm extensions 31 6.4 Provision of operating alarms .31 6.5 Provision of emergency clinical alarms 32 6.6 (*) Provision of emergency op

32、erating alarms .32 7 Pipeline distribution systems 33 7.1 Mechanical resistance 33 7.2 Distribution pressure .33 7.3 Low-pressure hose assemblies and low-pressure flexible connections 34 7.4 Double-stage pipeline distribution systems .35 8 Shut-off valves 35 8.1 General 35 8.2 Service shut-off valve

33、s .36 8.3 Area shut-off valves 36 9 T erminal units, g as-specific c onnect ors, medical suppl y units, pr essur e r egulat ors and pressure gauges 38 10 Marking and colour coding .38 10.1 Marking 38 10.2 Colour coding 38 11 Pipeline installation .39 11.1 General 39 11.2 Pipeline supports .40 11.3 P

34、ipeline joints .40 11.4 Extensions and modifications of existing pipeline systems 41 12 Testing and commissioning 41 12.1 General 41 12.2 General requirements for tests 42 12.3 Inspections and checks before concealment 42 12.4 Tests, checks and procedures before use of the system .42 12.5 Requiremen

35、ts for inspections and checks before concealment 43 12.5.1 Inspection of marking and pipeline supports43 12.5.2 Check for compliance with design specifications .43 12.6 Requirements for tests, checks and procedures before use of the system .43 12.6.1 General.43 12.6.2 (*) Tests of area shut-off valv

36、es for leakage and closure and checks for correct zoning and correct identification 45 12.6.3 Test for cross-connection 45 12.6.4 Test for obstruction and flow .46 12.6.5 Checks of terminal units and NIST , DISS or SIS connectors for mechanical function, gas specificity and identification .47 12.6.6

37、 Tests or checks of system performance 47 12.6.7 (*) Tests of pressure-relief valves .47 12.6.8 Tests of all sources of supply 48 12.6.9 Tests of monitoring and alarm systems 48 12.6.10 Test for particulate contamination of pipeline distribution systems 48 12.6.11 Tests of the quality of medical air

38、 produced by supply systems with air compressor(s) . 49 12.6.12 Tests of the quality of air for driving surgical tools produced by supply systems with air compressor(s) 49 12.6.13 Tests of the quality of medical air produced by supply systems with proportioning unit(s) . .49 12.6.14 Tests of the qua

39、lity of oxygen 93 produced by supply systems with oxygen concentrator(s) .49 12.6.15 Filling with specific gas .49 iv ISO 2016 All rights reservedBS EN ISO 7396-1:2016ISO 7396-1:2016(E)12.6.16 Tests of gas identity 49 12.6.17 Verification of restart after power supply failure .50 12.7 Statement of c

40、ompliance to this part of ISO 7396 .50 13 Information to be supplied by the manufacturer 50 13.1 General 50 13.2 Instructions for installation 50 13.3 Instructions for use 50 13.4 Operational management information .51 13.5 “ As-installed” drawings .52 13.6 Electrical diagrams .52 Annex A (informati

41、ve) Schematic representations of typical supply systems and area distribution systems 53 Annex B (informative) Guidelines for location of cylinder manifolds, cylinder storage areas and stationary vessels for cryogenic or non-cryogenic liquids 84 Annex C (informative) Example of procedure for testing

42、 and commissioning 85 Annex D (informative) Typical forms for documenting compliance of the pipeline systems for compressed medical gas and vacuum 98 Annex E (informative) Temperature and pressure relationships .128 Annex F (informative) Risk management checklist .130 Annex G (informative) Operation

43、al management147 Annex H (informative) Rationale .167 Annex I (informative) Rationale for compressor hazards .170 Annex J (informative) Considerations for implementation and use of oxygen 93 .171 Annex K (informative) Manufacture of medical gases on site, Responsibility for medical gas quality.173 B

44、ibliography .176 ISO 2016 All rights reserved vBS EN ISO 7396-1:2016ISO 7396-1:2016(E) Foreword 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 t

45、hrough ISO 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 colla

46、borates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 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 approv

47、al criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with 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 su

48、bject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any 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 tr

49、ade name used in this document is information given for the convenience of users and does not constitute an endorsement. 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 information The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems. This third edition cancels and repl