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1、 Reference number ISO 7396-1:2007(E) ISO 2007 INTERNATIONAL STANDARD ISO 7396-1 Second edition 2007-04-01 Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum Rseaux de distribution de gaz mdicaux Partie 1: Rseaux de distribution de gaz mdicaux comprims et de
2、 vide Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 05/08/2007 06:28:31 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 7396-1:2007(E) PDF disclaimer T
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5、 the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2007 All rights re
6、served. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requ
7、ester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2007 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO
8、Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 05/08/2007 06:28:31 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 7396-1:2007(E) ISO 2007 All rights reserved iii Contents Page Foreword. v Introduction. vi 1 Scope . 1 2 Normative references. 2 3 Te
9、rms and definitions. 2 4 General requirements. 7 4.1 (*) Safety 7 4.2 (*) Alternative construction 7 4.3 Materials 8 4.4 System design. 9 5 Supply systems. 10 5.1 System components. 10 5.2 General requirements. 10 5.3 Supply systems with cylinders or cylinder bundles. 12 5.4 Supply systems with mobi
10、le or stationary cryogenic or non-cryogenic vessels 13 5.5 Supply systems for air . 13 5.6 Supply systems with oxygen concentrator(s). 17 5.7 Supply systems for vacuum 18 5.8 Location of supply systems 18 5.9 Location of cylinder manifolds 19 5.10 Location of stationary cryogenic vessels 19 6 Monito
11、ring and alarm systems 19 6.1 General. 19 6.2 Installation requirements. 19 6.3 Monitoring and alarm signals 20 6.4 Provision of operating alarms. 21 6.5 Provision of emergency clinical alarms. 22 6.6 (*) Provision of emergency operating alarms 22 7 Pipeline distribution systems 22 7.1 Mechanical re
12、sistance 22 7.2 Distribution pressure 22 7.3 Low-pressure hose assemblies and low-pressure flexible connections 23 7.4 Double-stage pipeline distribution systems 24 8 Shut-off valves 24 8.1 General. 24 8.2 Service shut-off valves. 25 8.3 Area shut-off valves 25 9 Terminal units, gas-specific connect
13、ors, medical supply units, pressure regulators and pressure gauges. 26 10 Marking and colour coding 27 10.1 Marking 27 10.2 Colour coding 27 11 Pipeline installation 27 11.1 General. 27 11.2 Pipeline supports 28 11.3 Pipeline joints 29 Copyright International Organization for Standardization Provide
14、d by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 05/08/2007 06:28:31 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 7396-1:2007(E) iv ISO 2007 All rights reserved 11.4 Extensions and modifications of existing pipeline
15、 systems29 12 Testing, commissioning and certification29 12.1 General.29 12.2 General requirements for tests30 12.3 Inspections and checks before concealment 30 12.4 Tests, checks and procedures before use of the system.30 12.5 Requirements for inspections and checks before concealment .31 12.6 Requ
16、irements for tests, checks and procedures before use of the system.31 12.7 Certification of the systems.36 13 Information to be supplied by the manufacturer.37 13.1 General.37 13.2 Instructions for use.37 13.3 Operational management information38 13.4 “As-installed” drawings .38 13.5 Electrical diag
17、rams .38 Annex A (informative) Schematic representations of typical supply systems and area distribution systems39 Annex B (informative) Guidelines for location of cylinder manifolds, cylinder storage areas and stationary vessels for cryogenic or non-cryogenic liquids62 Annex C (informative) Example
18、 of procedure for testing and commissioning63 Annex D (informative) Typical forms for certification of the medical gas pipeline system75 Annex E (informative) Temperature and pressure relationships.105 Annex F (informative) Risk management checklist.107 Annex G (informative) Operational management12
19、0 Annex H (informative) Rationale .138 Bibliography .140 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 05/08/2007 06:28:31 MDTNo reproduction or networking permitted without license
20、 from IHS -,-,- ISO 7396-1:2007(E) ISO 2007 All rights reserved v 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 through ISO technical
21、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 with
22、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 Interna
23、tional 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 may b
24、e the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 7396-1 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in collaboration with Technical Committe
25、e ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). This second edition cancels and replaces the first edition (ISO 7396-1:2002), which has been technically revi
26、sed. ISO 7396 consists of the following parts, under the general title Medical gas pipeline systems: Part 1: Pipeline systems for compressed medical gases and vacuum Part 2: Anaesthetic gas scavenging disposal systems Copyright International Organization for Standardization Provided by IHS under lic
27、ense with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 05/08/2007 06:28:31 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 7396-1:2007(E) vi ISO 2007 All rights reserved Introduction Many healthcare facilities use pipeline systems to deliver
28、medical gases and to provide vacuum to areas where they are used in patient care or to power equipment such as ventilators and surgical tools. This part of ISO 7396 specifies requirements for pipeline systems for compressed medical gases, gases for driving surgical tools and vacuum. It is intended f
29、or use by those persons involved in the design, construction, inspection and operation of healthcare facilities treating human beings. Those persons involved in the design, manufacture and testing of equipment intended to be connected to pipeline systems should also be aware of the contents of this
30、document. This part of ISO 7396 seeks to ensure that medical gas pipelines contain only the specific gas (or vacuum) intended to be supplied. For this reason, gas-specific components are used for terminal units and for other connectors which are intended to be used by the operator. In addition, each
31、 system is tested and certified to contain only the specific gas (or vacuum). The objectives of this part of ISO 7396 are to ensure the following: a) non-interchangeability between different pipeline systems by design; b) continuous supply of gases and vacuum at specified pressures by providing appr
32、opriate sources; c) use of suitable materials; d) cleanliness of components; e) correct installation; f) provision of monitoring and alarm systems; g) correct marking of the pipeline system; h) testing, commissioning and certification; i) purity of the gases delivered by the pipeline system; j) corr
33、ect operational management. Annex H contains rationale statements for some of the requirements of this part of ISO 7396. It is included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this part of ISO 7396. The clauses
34、and subclauses marked with (*) after their number have a corresponding rationale contained in Annex H. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 05/08/2007 06:28:31 MDTNo reprod
35、uction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 7396-1:2007(E) ISO 2007 All rights reserved 1 Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum 1 Scope This part of ISO 7396 specifies requirements for design, instal
36、lation, function, performance, documentation, testing and commissioning of pipeline systems for compressed medical gases, gases for driving surgical tools and vacuum in healthcare facilities to ensure continuous delivery of the correct gas and the provision of vacuum from the pipeline system. It inc
37、ludes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas systems. This part of ISO 7396 is applicable to: a) pipeline systems for the following medical gases: oxygen; nitrous oxi
38、de; medical air; carbon dioxide; oxygen/nitrous oxide mixtures (see Note 1); b) pipeline systems for the following gases: (*) oxygen-enriched air; air for driving surgical tools; nitrogen for driving surgical tools; c) pipeline systems for vacuum. This part of ISO 7396 also applies to: extensions of
39、 existing pipeline distribution systems; modifications of existing pipeline distribution systems; modifications or replacement of supply systems or sources of supply. NOTE 1 Regional or national regulations can prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline system
40、s. (*) NOTE 2 EN 14931 23 defines additional or alternative requirements for the specific application, in particular for flows and pressures of compressed air required to pressurize the hyperbaric chambers and to drive other connected services and of oxygen and other treatment gases administered to
41、patients. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 05/08/2007 06:28:31 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 7396-1:2007(E) 2 ISO 2007 A
42、ll rights reserved 2 Normative references The following referenced documents are 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 374
43、6, 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 ISO 5359, Low-pressure hose assemblies for use with medical gases ISO 8573-1:2001, Compressed air Part 1: Conta
44、minants and purity classes ISO 9170-1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum ISO 10083, Oxygen concentrator supply systems for use with medical gas pipeline systems ISO 10524-2, Pressure regulators for use with medical
45、 gases Part 2: Manifold and line pressure regulators ISO 11197, Medical supply units ISO 14971, Medical devices Application of risk management to medical devices ISO 15001:2003, Anaesthetic and respiratory equipment Compatibility with oxygen ISO 21969, High-pressure flexible connections for use with
46、 medical gas systems IEC 60601-1-8, Medical electrical equipment Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 286-1, Simple unfired pressure vessels designed
47、 to contain air or nitrogen Part 1: Pressure vessels for general purposes EN 1041, Information supplied by the manufacturer with medical devices EN 13348, Copper and copper alloys Seamless, round copper tubes for medical gases or vacuum 3 Terms and definitions For the purposes of this document, the
48、following terms and definitions apply. 3.1 air compressor system supply system with compressor(s) designed to provide medical air or air for driving surgical tools or both 3.2 air for driving surgical tools natural or synthetic mixture of gases, mainly composed of oxygen and nitrogen in specified proportions, with defined limits for the concentration of contaminants, supplied by a medical gas pipeline system and intended for driving surgical tools NOTE Different names or symbols are used for air for d