BS-EN-ISO-11137-1-2006.pdf
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1、BRITISH STANDARD BS EN ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices The European Standard EN ISO 11137-1:2006 has the status of a British Standard ICS 11.080.01 ? L
2、icensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:51:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11137-1:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2006 BSI 2006 ISBN 0 580 49091 2 National foreword This
3、 British Standard is the official English language version of EN ISO 11137-1:2006. It is identical with ISO 11137-1:2006. It supersedes BS EN 552:1994 which will be withdrawn on 1 April 2009. The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medica
4、l devices, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue
5、under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct
6、application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; m
7、onitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to vi, pages 1 to 38, an inside back cover and a back cov
8、er. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:51:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE
9、EUROPISCHE NORM EN ISO 11137-1 April 2006 ICS 11.080.01Supersedes EN 552:1994 English Version Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) Strilisation des pr
10、oduits de sant - Irradiation - Partie 1: Exigences relatives la mise au point, la validation et au contrle de routine dun procd de strilisation pour les dispositifs mdicaux (ISO 11137-1:2006) Sterilisation von Produkten fr die Gesundheitsfrsorge - Strahlen - Teil 1: Anforderungen an die Entwicklung,
11、 Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens fr Medizinprodukte (ISO 11137- 1:2006) This European Standard was approved by CEN on 13 April 2006. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
12、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 Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, Fre
13、nch, 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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Repu
14、blic, 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. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE
15、 NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11137-1:2006: E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:
16、51:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword This European Standard shall be given the status of a national standard, either by publication of an identical withdrawn at the latest by April 2009. This document supersedes EN 552:1994. This document has been prepared under a mandate given
17、to CEN by the European Commission and the According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
18、Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 11137-1:2006 has been approved by CEN as EN ISO 11137-1:2006 without any modifications. EN ISO 11137-1:2006 This document (EN ISO 11137-1:2006) has been prepared by Technical Comm
19、ittee ISO/TC 198 “Sterilization of health care products“ in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices“, the secretariat of which is held by BSI. text or by endorsement, at the latest by October 2006, and conflicting national standards shall be withdrawn Euro
20、pean 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. countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, License
21、d Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:51:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 11137-1:2006(E) INTERNATIONAL STANDARD ISO 11137-1 First edition 2006-04-15 Sterilization of health care products Radiation Part 1: Requirements for development, validation and ro
22、utine control of a sterilization process for medical devices Strilisation des produits de sant Irradiation Partie 1: Exigences relatives la mise au point, la validation et au contrle de routine dun procd de strilisation pour les dispositifs mdicaux EN ISO 11137-1:2006 Licensed Copy: sheffieldun shef
23、fieldun, na, Fri Nov 17 09:51:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:51:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 2 3 Terms and definitions. 2 4 Qu
24、ality management system elements 8 4.1 Documentation 8 4.2 Management responsibility . 9 4.3 Product realization 9 4.4 Measurement, analysis and improvement Control of nonconforming product 9 5 Sterilizing agent characterization . 9 5.1 Sterilizing agent 9 5.2 Microbicidal effectiveness. 9 5.3 Mater
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