DIN EN ISO 7396-1-2016 Medical gas pipeline systems - Part 1 Pipeline systems for compressed medical gases and vacuum (ISO 7396-1 2016) German version EN ISO 7396-1 2016《医用气体管道系统 第.pdf

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1、September 2016 English price group 37No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10!%3j“2561671www.din.d

2、eDIN EN ISO 7396-1Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 73961:2016);English version EN ISO 73961:2016,English translation of DIN EN ISO 7396-1:2016-09Rohrleitungssysteme fr medizinische Gase Teil 1: Rohrleitungssysteme fr medizinische Druc

3、kgase und Vakuum (ISO 73961:2016);Englische Fassung EN ISO 73961:2016,Englische bersetzung von DIN EN ISO 7396-1:2016-09Systmes de distribution de gaz mdicaux Partie 1: Systmes de distribution de gaz mdicaux comprims et de vide (ISO 73961:2016);Version anglaise EN ISO 73961:2016,Traduction anglaise

4、de DIN EN ISO 7396-1:2016-09SupersedesDIN EN ISO 73961:201008,DIN EN ISO 73961/A3:201307 andDIN ISO 10083:200812See start of applicationwww.beuth.deDocument comprises 191 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.09.16 DI

5、N EN ISO 7396-1:2016-09 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2016-09-01. For DIN EN ISO 7396-1:2010-08 and DIN EN ISO 7396-1/A3:2013-07 there is a transition period ending on 2019-03-31. National foreword This document (EN ISO 739

6、6-1:2016) has been prepared by Technical Committee ISO/TC 121/SC 6 “Medical gas systems” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation w

7、as DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-03-06 AA Zentrale Gasversorgungsanlagen. During the process of revising ISO 7396-1:2007, the responsible International Committee decided to incorporate oxygen concen

8、trator supply systems for use with medical gas pipeline systems according to ISO 10083:2006 into the standard. These supply systems deliver type 93 oxygen, where the oxygen concentration may vary between 90 % and 96 %. As a result of the incorporation of ISO 10083 in this standard, the scope compris

9、es as before, supply systems in which all sources of supply deliver oxygen with an oxygen concentration exceeding 99 % and, in addition, supply systems in which all sources of supply deliver oxygen 93 with an oxygen concentration between 90 % and 96 %. In Germany, the relevant laws and regulations f

10、or medical oxygen are, in particular the Gesetz ber den Verkehr mit Arzneimitteln (Arzneimittelgesetz AMG) (Medicinal Products Act); the European Monograph for oxygen, according to which the minimum oxygen concentration in gas is 99,5 %; the European Monograph for oxygen 93, according to which the o

11、xygen concentration may vary between 90 % and 96 %. In Germany, the mixture of oxygen 93 and oxygen is subject to the adherence to pharmaceutical legislation. DIN EN ISO 7396 consists of the following parts, under the general title Medical gas pipeline systems: Part 1: Pipeline systems for compresse

12、d medical gases and vacuum Part 2: Anaesthetic gas scavenging disposal systems DIN EN ISO 7396-1:2016-09 3 The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 3746 DIN EN ISO 3746 ISO 4126-1 DIN EN ISO 4126-1 ISO 4135 DIN EN ISO 4135 ISO 53

13、59 DIN EN ISO 5359 ISO 7183 DIN ISO 7183 ISO 9001 DIN EN ISO 9001 ISO 9170-1 DIN EN ISO 9170-1 ISO 10524-2 DIN EN ISO 10524-2 ISO 10524-4 DIN EN ISO 10524-4 ISO 11114-1 DIN EN ISO 11114-1 ISO 11114-2 DIN EN ISO 11114-2 ISO 11197 DIN EN ISO 11197 (VDE 0750-211) ISO 13485:2003 DIN EN ISO 13485:2010-01

14、 ISO 13585 DIN EN ISO 13585 ISO 14644-1 DIN EN ISO 14644-1 ISO 14971 DIN EN ISO 14971 ISO 15001 DIN EN ISO 15001 ISO 17672 DIN EN ISO 17672 ISO 18082 DIN EN ISO 18082 ISO 21969 DIN EN ISO 21969 IEC 60601-1-8 DIN EN 60601-1-8 (VDE 0750-1-8) ISO 80601-2-69 DIN EN ISO 80601-2-69 Amendments This standar

15、d differs from DIN EN ISO 7396-1:2010-08, DIN EN ISO 7396-1/A3:2013-07 and DIN EN ISO 10083:2008-12 as follows: a) Amendment A3:2013-07 giving additional information relating to the terminology on alarm systems has been incorporated; b) due to the incorporation of oxygen concentrator supply systems

16、for use with medical gas pipeline systems according to ISO 10083, the standard has been completely revised; c) further informative Annexes have been added: 1) Rationale for compressor hazards (Annex I); 2) Considerations for implementation and use of oxygen 93 (Annex J); 3) Manufacture of medical ga

17、ses on site and responsibility for medial gas quality (Annex K); d) the standard has been editorially revised. Previous editions DIN 13260-1: 1990-12 DIN ISO 10083: 2008-12 DIN EN 737-3: 1998-11, 2000-01 DIN EN ISO 7396-1: 2007-07, 2010-08 DIN EN ISO 7396-1/A3: 2013-07 DIN EN ISO 7396-1:2016-09 4 Na

18、tional Annex NA (informative) Bibliography DIN EN 60601-1-8 (VDE 0750-1-8), Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medic

19、al electrical systems DIN EN ISO 3746, Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane DIN EN ISO 4126-1, Safety devices for protection against excessive pressure

20、 Part 1: Safety valves DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 5359, Low-pressure hose assemblies for use with medical gases DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO 9170-1, Terminal units for medical gas pipeline systems Part 1: Termin

21、al units for use with compressed medical gases and vacuum DIN EN ISO 10524-2, Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators DIN EN ISO 10524-4, Pressure regulators for use with medical gases Part 4: Low-pressure regulators DIN EN ISO 11114-1, Gas cylind

22、ers Compatibility of cylinder and valve materials with gas contents Part 1: Metallic materials DIN EN ISO 11114-2, Gas cylinders Compatibility of cylinder and valve materials with gas contents Part 2: Non-metallic materials DIN EN ISO 11197 (VDE 0750-211), Medical supply units DIN EN ISO 13485:2010-

23、01, Medical devices Quality management systems Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009) DIN EN ISO 13585, Brazing Qualification test of brazers and brazing operators DIN EN ISO 14644-1, Cleanrooms and associated controlled environments Part 1: Classification of air cleanli

24、ness by particle concentration DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygen DIN EN ISO 17672, Brazing Filler metals DIN EN ISO 18082, Anaesthetic and respiratory equipment Dimensi

25、ons of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases DIN EN ISO 21969, High-pressure flexible connections for use with medical gas systems DIN EN ISO 80601-2-69, Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential perfo

26、rmance of of oxygen concentrator equipment DIN ISO 7183, Compressed air dryers Specifications and testing EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7396-1 March 2016 ICS 11.040.10 Supersedes EN ISO 7396-1:2007English Version Medical gas pipeline systems - Part 1: Pipeline systems for

27、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: Rohrleitungssysteme fr medizinische Druckgase und Vakuum (ISO 7396-1

28、: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 standard without any alteration. Up-to-date lists and bibliographi

29、cal 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 any other language made by translation under the responsibility

30、 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 Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of

31、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 COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION

32、 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 EForeword 8Introduction 91 (*) Scope . 112 Normative references .

33、123 Terms and definitions 134 General requirements 194.1 (*) Safety 194.2 (*) Alternative construction .204.3 Materials 204.4 System design224.4.1 General. 224.4.2 Extensions and modifications of existing pipeline systems 225 Supply systems 235.1 System components .235.2 General requirements 235.2.1

34、 Capacity and storage . 235.2.2 Continuity of supply . 235.2.3 Primary source of supply. 245.2.4 Secondary source of supply . 245.2.5 Reserve source(s) of supply 245.2.6 Means of pressure relief .255.2.7 Maintenance supply assembly 255.2.8 Pressure regulators 265.2.9 (*)Ozone Sterilizers 265.3 Suppl

35、y systems with cylinders, cylinder bundles or high-pressure reservoir(s) .265.4 Supply systems with cryogenic or non-cryogenic vessels 265.5 Supply systems for air 275.5.1 General requirements .275.5.2 Supply systems with air compressor(s) .285.5.3 Supply systems with proportioning unit(s) 315.6 Sup

36、ply systems with oxygen concentrator(s) . 335.6.1 General requirements .335.6.2 Primary source of supply. 335.6.3 Secondary source of supply . 335.6.4 Reserve source of supply .345.6.5 Specifications for oxygen 93 . 345.6.6 Oxygen concentrator unit 355.6.7 Oxygen 93 reservoirs 355.6.8 Oxygen analyse

37、rs 355.6.9 Local filling of permanently attached high-pressure reservoir(s), acting as reserve source of supply 365.7 Supply systems for vacuum .375.8 Location of supply systems .385.9 Location of cylinder manifolds . 385.10 Location of stationary cryogenic vessels . 396 Monitoring and alarm systems

38、 .396.1 General 396.2 Installation requirements . 39Contents PageEuropean foreword 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices 6 .DIN EN ISO 7396-1:2016-09 EN ISO 7396-1:2016 (E) 2 6.3.4 Emergency an

39、d operating alarm characteristics 406.3.5 Information signals . 416.3.6 Remote alarm extensions 416.4 Provision of operating alarms .416.5 Provision of emergency clinical alarms 426.6 (*) Provision of emergency operating alarms .427 Pipeline distribution systems 437.1 Mechanical resistance 437.2 Dis

40、tribution pressure . 437.3 Low-pressure hose assemblies and low-pressure flexible connections 447.4 Double-stage pipeline distribution systems . 458 Shut-off valves 458.1 General 458.2 Service shut-off valves .468.3 Area shut-off valves 469 Terminal units, gas-specific connectors, medical supply uni

41、ts, pressure regulators and pressure gauges 4810 Marking and colour coding .4810.1 Marking 4810.2 Colour coding 4811 Pipeline installation .4911.1 General 4911.2 Pipeline supports . 5011.3 Pipeline joints . 5011.4 Extensions and modifications of existing pipeline systems 5112 Testing and commissioni

42、ng 5112.1 General 5112.2 General requirements for tests 5212.3 Inspections and checks before concealment 5212.4 Tests, checks and procedures before use of the system .5212.5 Requirements for inspections and checks before concealment 5312.5.1 Inspection of marking and pipeline supports 5312.5.2 Check

43、 for compliance with design specifications . 5312.6 Requirements for tests, checks and procedures before use of the system . 5312.6.1 General. 5312.6.2 (*) Tests of area shut-off valves for leakage and closure and checks for correct zoning and correct identification 5512.6.3 Test for cross-connectio

44、n 5512.6.4 Test for obstruction and flow . 5612.6.5 Checks of terminal units and NIST, DISS or SIS connectors for mechanical function, gas specificity and identification . 5712.6.6 Tests or checks of system performance 5712.6.7 (*) Tests of pressure-relief valves .5712.6.8 Tests of all sources of su

45、pply 5812.6.9 Tests of monitoring and alarm systems 5812.6.10 Test for particulate contamination of pipeline distribution systems 5812.6.11 Tests of the quality of medical air produced by supply systems with air compressor(s) . 5912.6.12 Tests of the quality of air for driving surgical tools produce

46、d by supply systems with air compressor(s) 5912.6.13 Tests of the quality of medical air produced by supply systems with proportioning unit(s) 596.3 Monitoring and alarm signals . 406.3.1 General. 406.3.2 Auditory signals . 406.3.3 Visual signals 40DIN EN ISO 7396-1:2016-09 EN ISO 7396-1:2016 (E) 3

47、12.6.16 Tests of gas identity 5912.6.17 Verification of restart after power supply failure . 6012.7 Statement of compliance to this part of ISO 7396 . 6013 Information to be supplied by the manufacturer 6013.1 General 6013.2 Instructions for installation 6013.3 Instructions for use 6013.4 Operationa

48、l management information . 6113.5 “As-installed” drawings . 6213.6 Electrical diagrams . 62Annex A (informative) Schematic representations of typical supply systems and area distribution systems 63Annex B (informative) Guidelines for location of cylinder manifolds, cylinder storage areas and stationary vessels for cryogenic or non-cryogenic liquids 93Annex C (informative) Example of procedure for testing and commissioning 94Annex D (informative) Typical forms for documenting compliance of the pipeline systems for compressed medi