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1、BRITISH STANDARD BS EN ISO 7396-2:2007 Incorporating corrigendum no. 1 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems The European Standard EN ISO 7396-2:2007 has the status of a British Standard ICS 11.040.10 ? Licensed Copy: London South Bank University, London So
2、uth Bank University, Wed Aug 08 03:51:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 7396-2:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2007 BSI 2007 ISBN 978 0 580 50763 2 National foreword This British Standard is t
3、he UK implementation of EN ISO 7396-2:2007. It supersedes BS EN 737-2:1998 which will be withdrawn on 30 April 2009. The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/6, Medical gas supply systems. A lis
4、t of organizations represented on this subcommittee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from
5、legal obligations. Amendments issued since publication Amd. No. DateComments 17199 Corrigendum No. 1 31 July 2007Change to supersession details Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:51:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD
6、NORME EUROPENNE EUROPISCHE NORM EN ISO 7396-2 April 2007 ICS 11.040.10Supersedes EN 737-2:1998 English Version Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) Rseaux de distribution de gaz mdicaux - Partie 2: Rseaux dvacuation de gaz danesthsie no
7、n rutilisables (ISO 7396-2:2007) Rohrleitungssysteme fr medizinische Gase - Teil 2: Entsorgungssysteme von Ansthesiegas- Fortleitungssystemen (ISO 7396-2:2007) This European Standard was approved by CEN on 15 March 2007. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
8、 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 CEN Management Centre or to any CEN member. This European Sta
9、ndard 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 status as the official versions. CEN members are the national s
10、tandards 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
11、 Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7396-2:20
12、07: E Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:51:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 7396-2:2007) has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment“, the secretariat of
13、which is held by BSI, in collaboration with Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“. 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 October 2007, and conflicting na
14、tional standards shall be withdrawn at the latest by October 2007. This document supersedes EN 737-2:1998. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For rela
15、tionship 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 organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, C
16、zech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN ISO 7396-2:2007 Licensed Copy: London South
17、 Bank University, London South Bank University, Wed Aug 08 03:51:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO 7396-2:2007(E) INTERNATIONAL STANDARD ISO 7396-2 Second edition 2007-04-01 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems Rseaux de di
18、stribution de gaz mdicaux Partie 2: Rseaux dvacuation de gaz danesthsie non rutilisables EN ISO 7396-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:51:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London
19、 South Bank University, Wed Aug 08 03:51:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2 4 General requirements. 6 4.1 Safety . 6 4.2 Alternative construction 6 4.3 Materials 6 4.4 Continuity
20、of operation 7 5 Power device. 7 6 Indicating systems 8 7 Pipelines, connecting assemblies and disposal hoses 8 8 Disposal system characteristics and test methods for pressure and flow 9 8.1 Requirements 9 8.2 Test methods for pressure and flow. 10 8.3 Means to prevent backflow 12 9 Terminal units .
21、 12 10 Marking and colour coding 12 10.1 Marking 12 10.2 Colour coding 13 10.3 Test for durability 13 11 Pipeline installation 13 12 Testing, commissioning and certification 15 12.1 General. 15 12.2 General requirements for tests . 15 12.3 Tests, inspections and checks 15 12.4 Requirements for tests
22、, inspections and checks listed in 12.3. 15 12.5 Certification of the system. 16 12.6 Extensions or modifications 17 13 Information to be supplied by the manufacturer. 17 13.1 General. 17 13.2 Instructions for use 17 13.3 Operational management information 18 13.4 “As-installed” drawings. 18 13.5 El
23、ectrical diagrams. 18 Annex A (informative) Guidelines for power devices consisting of fans, blowers or dedicated vacuum pumps 19 Annex B (informative) Example of procedure for testing and commissioning 20 Annex C (informative) Typical forms for certification of AGS disposal systems 23 Annex D (info
24、rmative) Risk management checklist 36 Annex E (informative) Rationale . 44 Bibliography. 45 EN ISO 7396-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:51:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for
25、 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 established has the
26、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 standardization. Internatio
27、nal 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 International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication a
28、s 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 be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. I
29、SO 7396-2 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in collaboration with Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems, in accordance with th
30、e Agreement on technical cooperation between ISO and CEN (Vienna Agreement). This second edition cancels and replaces the first edition (ISO 7396-2:2000), which has been technically revised. ISO 7396 consists of the following parts, under the general title Medical gas pipeline systems: Part 1: Pipel
31、ine systems for compressed medical gases and vacuum Part 2: Anaesthetic gas scavenging disposal systems EN ISO 7396-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:51:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI v Introduction Anaesthetic gas scavengi
32、ng systems (AGSS) are used to reduce occupational exposure to anaesthetic gases and vapours. The anaesthetic gas scavenging system comprises three main parts: a transfer system, a receiving system, and a disposal system. A schematic diagram of typical anaesthetic gas scavenging systems is shown in F
33、igure 1. Requirements for receiving systems and transfer systems are specified in ISO 8835-3. Type-specific connections for terminal units are specified in ISO 9170-2. In this part of ISO 7396, specifications and test procedures are given to ensure compatibility between the components of the system.
34、 This part of ISO 7396 specifies requirements for pipelines for anaesthetic gas scavenging systems for anaesthetic gases and vapours. It is intended for use by those persons involved in the design, construction, inspection and operation of healthcare facilities treating human beings. It is advisable
35、 that those persons involved in the design, manufacture and testing of equipment intended to be connected to pipeline systems also be aware of the contents of this part of ISO 7396. Specific components are used for scavenging terminal units and for other connectors which are intended to be used by t
36、he operator. In addition, the system is tested and certified to operate at safe flows and without leakage. It is also intended to address issues of patient safety. The objectives of this part of ISO 7396 are to ensure the following: a) avoidance of cross connections between different pipeline system
37、s; b) continuity of function of the system; c) use of suitable materials; d) cleanliness of components; e) correct installation; f) provision of indicating system(s); g) correct marking of the pipeline system and components; h) testing, commissioning and certification; i) correct operational managem
38、ent. Annex E 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 and subclauses marked w
39、ith (*) after their number have corresponding rationale contained in Annex E. EN ISO 7396-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:51:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI blank Licensed Copy: London South Bank University, London South B
40、ank University, Wed Aug 08 03:51:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 1 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems 1 Scope This part of ISO 7396 specifies requirements for the design, installation, function, performance, documentation, testing and commi
41、ssioning of anaesthetic gas scavenging disposal systems to ensure patient safety and to minimize exposure of the operator and other persons to anaesthetic gases and vapours. It includes requirements for the power device, pipeline system, performance, non-interchangeability between key components and
42、 avoidance of cross connections between anaesthetic gas scavenging (AGS) disposal systems and medical gas and vacuum pipeline systems. NOTE In this part of ISO 7396, the term “pipeline” refers exclusively to pipelines that are part of a dedicated anaesthetic gas scavenging system (AGSS). This part o
43、f ISO 7396 is applicable only to those disposal systems intended to be connected via AGSS terminal units conforming to ISO 9170-2 and to AGSS receiving systems conforming to ISO 8835-3. This part of ISO 7396 also applies to: extensions of existing AGSS disposal systems; modifications of existing AGS
44、S disposal systems; modifications or replacement of power devices. 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 docu
45、ment (including any amendments) applies. ISO 5359, Low-pressure hose assemblies for use with medical gases ISO 7396-1:2007, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum ISO 8835-3:1), Inhalational anaesthesia systems Part 3: Transfer and receiving sys
46、tems of active anaesthetic gas scavenging systems ISO 9170-2, Terminal units for medical gas pipeline systems Part 2: Terminal units for anaesthetic gas scavenging systems 1) To be published. (Revision of ISO 8835-3:1997.) EN ISO 7396-2:2007 Licensed Copy: London South Bank University, London South
47、Bank University, Wed Aug 08 03:51:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 2 ISO 14971, Medical devices Application of risk management to medical devices ISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygen EN 1041, Information supplied by the manufacturer with medical dev
48、ices 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 following terms and definitions apply. 3.1 AGSS socket female part of a terminal unit which is either integral or attached to the base block
49、 by a type-specific interface, and which contains the type-specific connection point 3.2 AGSS terminal unit inlet assembly in an AGSS at which the operator makes connections and disconnections 3.3 AGSS terminal unit base block part of an AGSS terminal unit which is attached to the pipeline disposal system 3.4 AGSS type 1 terminal unit connection point between the receiving system and the disposal system at which an operator makes connections and disconnect