BS-EN-ISO-11737-1-2006.pdf
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1、BRITISH STANDARD BS EN ISO 11737-1:2006 Incorporating corrigendum May 2007 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products ICS 07.100.10; 11.080.01 ? BS EN ISO 11737-1:2006 This British Standard was published under the auth
2、ority of the Standards Policy and Strategy Committee on 28 April 2006 BSI 2008 ISBN 978 0 580 62655 5 National foreword This British Standard is the UK implementation of EN ISO 11737-1:2006. It is identical with ISO 11737-1:2006, incorporating corrigendum May 2007. It supersedes BS EN 1174-1:1996, B
3、S EN 1174-2:1997 and BS EN 1174-3:1997 which are withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical instruments. A list of organizations represented on this committee can be obtained on request to its secretary. This publication d
4、oes 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 legal obligations. Amendments/corrigenda issued since publication DateComments 30 June 2008Implementation of ISO co
5、rrigendum May 2007. Correction to second paragraph of A.7.2 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11737-1 April 2006 ICS 07.100.10; 11.080.01 Supersedes EN 1174-1:1996, EN 1174-2:1996, EN 1174-3:1996 English Version Sterilization of medical devices - Microbiological methods - Part
6、 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) Strilisation des dispositifs mdicaux - Mthodes microbiologiques - Partie 1: Dtermination dune population de micro-organismes sur des produits (ISO 11737-1:2006) Sterilisation von Medizinprodukten - Mikrobiologische Ve
7、rfahren - Teil 1: Bestimmung der Population von Mikroorganismen auf Produkten (ISO 11737-1:2006) This European Standard was approved by CEN on 23 March 2006. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the
8、 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, French, German)
9、. 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 Republic, Denmar
10、k, 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 NORMALISATI
11、ON EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11737-1:2006: E Foreword This document (EN ISO 11737-1:2006) has been prepared by Tec
12、hnical Committee 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. This European Standard shall be given the status of a national standard, either by publication of an i
13、dentical text or by endorsement, at the latest by October 2006, and conflicting national standards shall be withdrawn at the latest by October 2006. This document supersedes EN 1174-1:1996, EN 1174-2:1996 and EN 1174-3:1996. This document has been prepared under a mandate given to CEN by the Europea
14、n Commission and the European 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. According to the CEN/CENELEC Internal Regulations, the national standards organiz
15、ations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slova
16、kia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 11737-1:2006 has been approved by CEN as EN ISO 11737-1:2006 without any modifications. BS EN ISO 11737-1:2006 -,-,- iii Contents Page Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and def
17、initions. 2 4 Quality management system elements 4 4.1 Documentation 4 4.2 Management responsibility . 4 4.3 Product realization 4 4.4 Measurement, analysis and improvement Control of nonconforming product 5 5 Selection of product. 5 5.1 General. 5 5.2 Sample item portion (SIP) 5 6 Methods of determ
18、ination and microbial characterization of bioburden . 6 6.1 Determination of bioburden. 6 6.2 Microbial characterization of bioburden 7 7 Validation of method for determining bioburden 7 8 Routine determination of bioburden and interpretation of data 7 9 Maintenance of the method of determination of
19、 bioburden. 8 9.1 Changes to the product and/or manufacturing process 8 9.2 Changes to the method of determination of bioburden . 8 9.3 Revalidation of the method of determination of bioburden. 8 Annex A (informative) Guidance on determination of a population of microorganisms on product 9 Annex B (
20、informative) Guidance on methods of determination of bioburden. 22 Annex C (informative) Validation of bioburden methods. 31 Bibliography. 34 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directives 90/385/EEC concerning active implantable me
21、dical devices, 93/42/EEC concerning medical devices and 98/79/EC concerning in vitro diagnostic medical devices . 36 BS EN ISO 11737-1:2006 -,-,- blank v Introduction A sterile medical device is one that is free of viable microorganisms. International standards that specify requirements for validati
22、on and routine control of sterilization processes, require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions in a
23、ccordance with the requirements for quality management systems (see, for example, ISO 13485) may, prior to sterilization, have microorganisms on them, albeit in low numbers. Such products are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby tran
24、sform the non-sterile products into sterile ones. The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices can generally best be described by an exponential relationship between the numbers of microorganisms surviving and t
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