BS-EN-ISO-10993-3-2003.pdf
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1、BRITISH STANDARD BS EN ISO 10993-3:2003 Incorporating Corrigendum No. 1 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity The European Standard EN ISO 10993-3:2003 has the status of a British Standard ICS 11.100 ? Licensed Copy: sheffi
2、eldun sheffieldun, na, Fri Nov 17 10:07:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10993-3:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2003 BSI 23 December 2003 ISBN 0 580 42881 8 National foreword This Britis
3、h Standard is the official English language version of EN ISO 10993-3:2003. It is identical with ISO 10993-3:2003. It supersedes BS EN 30993-3:1994 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/194, Biological evaluation of medical devices, which
4、 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 under the sectio
5、n 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 application. Com
6、pliance 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 the UK interests informed; monitor relat
7、ed 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 16, the Annex ZA page, the Annex ZB page, an inside
8、 back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments 14920 Corrigendum No. 1 23 December 2003Correction to EN ISO foreword page and Annex ZA page, and incorporation of
9、Annex ZB page Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-3 October 2003 ICS 11.100Supersedes EN 30993-3:1993 English version Biological evaluation of medical devices - Part
10、3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) Evaluation biologique des dispositifs mdicaux - Partie 3: Essais concernant la gnotoxicit, la cancrognicit et la toxicit sur la reproduction (ISO 10993-3:2003) Biologische Beurteilung von Medizinprodukten - Teil
11、3: Prfungen auf Gentoxizitt, Karzinogenitt und Reproduktionstoxizitt (ISO 10993-3:2003) This European Standard was approved by CEN on 1 October 2003. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status
12、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 Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A versio
13、n in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France,
14、Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-
15、1050 Brussels 2003 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10993-3:2003 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CORRECTED 2003-12-03 Foreword This docu
16、ment (EN ISO 10993-3:2003) has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of medical devices“ in collaboration with Technical Committee CEN/TC 206 “Biocompatibility of medical and dental materials and devices“, the secretariat of which is held by NEN. This European Standa
17、rd shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2004, and conflicting national standards shall be withdrawn at the latest by April 2004. This document supersedes EN 30993-3:1993. This document has been prepared
18、 under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this document. According to the CEN/CENELEC Internal
19、 Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spai
20、n, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10993-3:2003 has been approved by CEN as EN ISO 10993-3:2003 without any modifications. NOTE Normative references to International Standards are listed in Annex ZA (normative). EN ISO 109933:2003 Licensed Copy: sheffie
21、ldun sheffieldun, na, Fri Nov 17 10:07:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 10993-3:2003(E) OSI 3002 INTERNATIONAL STANDARD ISO 10993-3 Second edition 2003-10-15 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive to
22、xicity valuation biologique des dispositifs mdicaux Partie 3: Essais concernant la gnotoxicit, la cancrognicit et la toxicit sur la reproduction EN ISO 109933:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-39901 O3:(3002E) DPlcsid F
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