BS-EN-ISO-11137-2-2007.pdf
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1、BRITISH STANDARD BS EN ISO 11137-2:2007 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose The European Standard EN ISO 11137-2:2007 has the status of a British Standard ICS 11.080.01 ? Licensed Copy: London South Bank University, London South Bank University
2、, Mon Jul 16 04:04:39 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 11137-2:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 June 2007 BSI 2007 ISBN 978 0 580 53286 3 National foreword This British Standard was published by BSI.
3、 It is the UK implementation of EN ISO 11137-2:2007. It is identical with ISO 11137-2:2006. Together with BS EN ISO 11137-1:2006 and BS EN ISO 11137-3:2006, it supersedes BS EN 552:1994 which will be withdrawn on 1 April 2009. NOTE EN 552:1994 was partially superseded by EN ISO 11137-2:2006, which w
4、as not adopted as a British Standard. The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include
5、 all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank U
6、niversity, Mon Jul 16 04:04:39 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11137-2 May 2007 ICS 11.080.01Supersedes EN 552:1994, EN ISO 11137-2:2006 English Version Sterilization of health care products - Radiation - Part 2: Establishing the st
7、erilization dose (ISO 11137-2:2006, corrected version 2006-08-01) Strilisation des produits de sant - Irradiation - Partie 2: tablissement de la dose strilisante (ISO 11137-2:2006, version corrige 2006-08-01) Sterilisation von Produkten fr die Gesundheitsfrsorge - Strahlen - Teil 2: Festlegung der S
8、terilisationsdosis (ISO 11137-2:2006, korrigierte fassung 2006-08-01) This European Standard was approved by CEN on 12 May 2007. 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 standar
9、d 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 Standard exists in three official versions (English, French, German). A version in any other la
10、nguage 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 standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Fin
11、land, 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 NORMALISATION EUROPISCHES
12、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 11137-2:2007: E Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16
13、 04:04:39 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Foreword The text of ISO 11137-2:2006, corrected version 2006-08-01 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as
14、EN ISO 11137-2:2007 by Technical Committee CEN/TC 204 “Sterilization of medical devices“, 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 November 2007, an
15、d conflicting national standards shall be withdrawn at the latest by May 2010. This document supersedes EN 552:1994 and EN ISO 11137-2:2006 together with all parts of EN ISO 11137. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Ass
16、ociation, 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. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound
17、to implement this European Standard: 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, Swit
18、zerland and United Kingdom. Endorsement notice The text of ISO 11137-2:2006, corrected version 2006-08-01 has been approved by CEN as EN ISO 11137-2:2007 without any modifications. EN ISO 11137-2:2007 Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:39 GMT+
19、00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO 11137-2:2006(E) INTERNATIONAL STANDARD ISO 11137-2 First edition 2006-04-15 Corrected version 2006-08-01 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose Strilisation des produits de sant Irradiati
20、on Partie 2: tablissement de la dose strilisante EN ISO 11137-2:2007 Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:39 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:0
21、4:39 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iii Contents Page Foreword. v Introduction. vi 1 Scope 1 2 Normative references1 3 Abbreviations, terms and definitions 1 3.1 Abbreviations.1 3.2 Terms 3 4 Definition and maintenance of product families for dose setting, dose substantiation and sterili
22、zation dose auditing 4 4.1 General4 4.2 Defining product families4 4.3 Designation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit .5 4.4 Maintaining product families6 4.5 Effect of failure of establishment of sterilization dose
23、or of a sterilization dose audit on a product family7 5 Selection and testing of product for establishing and verifying the sterilization dose.7 5.1 Nature of product.7 5.2 Sample item portion (SIP).8 5.3 Manner of sampling.8 5.4 Microbiological testing9 5.5 Irradiation .9 6 Methods of dose establis
24、hment.9 7 Method 1: dose setting using bioburden information .10 7.1 Rationale.10 7.2 Procedure for Method 1 for product with an average bioburden W W 1,0 for multiple production batches11 7.3 Procedure for Method 1 for product with an average bioburden W W 1,0 for a single production batch16 7.4 Pr
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