BS-EN-ISO-17665-1-2006.pdf
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1、BRITISH STANDARD BS EN ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices The European Standard EN ISO 17665-1:2006 has the status of a British Standard ICS 11.080.0
2、1 ? BS EN ISO 17665-1:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 September 2006 BSI 2006 ISBN 0 580 48982 5 National foreword This British Standard was published by BSI. It is the UK implementation of EN ISO 17665-1:2006. It supe
3、rsedes BS EN 554:1994 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices. A list of organizations represented on CH/198 can be obtained on request to its secretary. This publication does not purport to include all
4、 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 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17665-1 Aug
5、ust 2006 ICS 11.080.01Supersedes EN 554:1994 English Version Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665- 1:2006) Strilisation des produits de sant - Chaleur hu
6、mide - Partie 1: Exigences pour le dveloppement, la validation et le contrle de routine dun procd de strilisation des dispositifs mdicaux (ISO 17665-1:2006) Sterilisation von Produkten fr die Gesundheitsfrsorge - Feuchte Hitze - Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der A
7、nwendung eines Sterilisationsverfahrens fr Medizinprodukte (ISO 17665- 1:2006) This European Standard was approved by CEN on 14 July 2006. 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 nation
8、al 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). A version in any
9、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, Denmark, Estonia, Finland
10、, 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 KOMI
11、TEE 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 17665-1:2006: E Foreword This document (EN ISO 17665-1:2006) has been prepared by Technical Committee ISO
12、/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 identical text or by
13、endorsement, at the latest by February 2007, and conflicting national standards shall be withdrawn at the latest by August 2009. This document supersedes EN 554:1994. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and
14、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 to implement t
15、his 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, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingd
16、om. Endorsement notice The text of ISO 17665-1:2006 has been approved by CEN as EN ISO 17665-1:2006 without any modifications. EN ISO 17665-1:2006 Reference number ISO 17665-1:2006(E) INTERNATIONAL STANDARD ISO 17665-1 First edition 2006-08-15 Sterilization of health care products Moist heat Part 1:
17、 Requirements for the development, validation and routine control of a sterilization process for medical devices Strilisation des produits de sant Chaleur humide Partie 1: Exigences pour le dveloppement, la validation et le contrle de routine dun procd de strilisation des dispositifs mdicaux EN ISO
18、17665-1:2006 ii iii Contents Page Foreword. v Introduction. vi 1 Scope . 1 1.1 Inclusions 1 1.2 Exclusions. 1 2 Normative references. 2 3 Terms and definitions. 3 4 Quality management system elements 10 4.1 Documentation 10 4.2 Management responsibility . 10 4.3 Product realization 10 4.4 Measuremen
19、t, analysis and improvement Control of non-conforming product. 10 5 Sterilizing agent characterization . 11 5.1 Sterilizing agent 11 5.2 Microbicidal effectiveness. 11 5.3 Materials effects 11 5.4 Environmental consideration 11 6 Process and equipment characterization 11 6.1 Process 11 6.1.1 General
20、. 11 6.1.2 Saturated steam processes. 12 6.1.3 Contained product processes. 12 6.2 Equipment . 13 7 Product definition. 14 8 Process definition. 15 9 Validation. 17 9.1 General. 17 9.2 Installation qualification (IQ) . 17 9.2.1 Equipment . 17 9.2.2 Installation. 17 9.2.3 Function. 17 9.3 Operational
21、 qualification (OQ). 18 9.4 Performance qualification (PQ). 18 9.5 Review and approval of validation 19 10 Routine monitoring and control 20 11 Product release from sterilization. 21 12 Maintaining process effectiveness. 21 12.1 Demonstration of continued effectiveness 21 12.2 Recalibration . 21 12.
22、3 Maintenance of equipment 21 12.4 Requalification 22 12.5 Assessment of change. 22 Annex A (informative) Guidance. 23 Annex B (informative) Process definition based on inactivation of the microbial population in its natural state (bioburden-based method) 27 EN ISO 17665-1:2006 iv Annex C (informati
23、ve) Process definition based on the inactivation of a reference microorganism and a knowledge of bioburden on product items to be sterilized (combined bioburden/biological indicator based method)28 Annex D (informative) Conservative process definition based on inactivation of reference microorganism
24、s (overkill method)29 Annex E (informative) Operating cycles.31 Bibliography .36 EN ISO 17665-1:2006 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC, 93/42/EEC and 98/79/EEC 39 v Foreword ISO (the International Organization
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