BS-EN-ISO-15002-2008.pdf
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1、BRITISH STANDARD BS EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems ICS 11.040.10 ? Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI BS EN ISO 15002:2008 This British Standard was published under the a
2、uthority of the Standards Policy and Strategy Committee on 29 August 2008 BSI 2008 ISBN 978 0 580 55059 1 National foreword This British Standard is the UK implementation of EN ISO 15002:2008. It supersedes BS EN 13220:1999 which is withdrawn. The UK participation in its preparation was entrusted by
3、 Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee 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 provisions of a
4、contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication DateComments Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI EUROPE
5、AN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15002 July 2008 ICS 11.040.10Supersedes EN 13220:1998 English Version Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) Dispositifs de mesure de dbit pour raccordement aux prises murales des syst
6、mes de distribution de gaz mdicaux (ISO 15002:2008) Durchflussmesseinrichtungen zum Anschluss an Entnahmestellen von Rohrleitungssystemen fr medizinische Gase (ISO 15002:2008) This European Standard was approved by CEN on 21 June 2008. CEN members are bound to comply with the CEN/CENELEC Internal Re
7、gulations which 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. Th
8、is European Standard 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
9、 the national standards 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, Switzer
10、land and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. E
11、N ISO 15002:2008: E Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 15002:2008) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collaboration with Technical Committee CEN/TC 215 “
12、Respiratory and anaesthetic equipment” the 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 January 2009, and conflicting national standards shall be withdrawn
13、at the latest by July 2010. Attention 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 13220:1998. This document has
14、been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC I
15、nternal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg,
16、 Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15002:2008 has been approved by CEN as a EN ISO 15002:2008 without any modification. BS EN ISO 15002:2008 Licensed CopyChinese University
17、of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI iii Contents Page Introduction v 1 Scope . 1 2 *Normative references 2 3 Terms and definitions. 2 4 Arrangement of flow-metering systems and devices. 4 5 General requirements. 4 5.1 Safety . 4 5.2 Alternative construction 4 5.3 Materials 4 5
18、.4 Design requirements 5 5.5 Constructional requirements. 10 6 Test methods. 10 6.1 General. 10 6.2 Test method for mechanical strength. 11 6.3 Test method for leakage 11 6.4 Test method for durability of markings and colour coding 12 7 Marking, colour coding and packaging 12 7.1 Marking 12 7.2 Colo
19、ur coding 13 7.3 Packaging 13 8 Information to be supplied by the manufacturer. 13 Annex A (informative) Rationale. 15 Annex B (informative) Arrangements of flow-metering systems and devices 17 Annex C (informative) Environmental aspects 20 Bibliography. 21 BS EN ISO 15002:2008 Annex ZA (informative
20、) Correspondence between this International Standard and Directive 93/42/EEC 22 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI blank Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI v Introduction Flow-metering dev
21、ices are widely used for delivery of medical gases supplied by a medical gas supply system directly to a patient. These devices need to deliver accurate flows under varying conditions of temperature and inlet pressure. Therefore it is important that the operating characteristics be specified and tes
22、ted in a defined manner. This International Standard pays particular attention to: safety (mechanical strength, safe relief of excess pressure, resistance to ignition); gas specificity; cleanliness; suitability of materials; accuracy; testing; identification; information supplied. Annex A contains r
23、ationale statements for some of the requirements of this International Standard. The clauses and subclauses marked with an asterix (*) after their number have corresponding rationale contained in informative Annex A, included to provide additional insight into the reasoning that led to the requireme
24、nts and recommendations that have been incorporated in this International Standard. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this International Standard, but will expedite any subsequent revisions. BS EN ISO 15002:2008 Lic
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