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1、BRITISH STANDARD BS EN ISO 13485:2001 Quality systems Medical devices Particular requirements for the application of EN ISO 9001 (revision of EN 46001:1996) (identical to ISO 13485:1996) The European Standard EN ISO 13485:2000 has the status of a British Standard ICS 03.120.10; 11.040.01 NO COPYING
2、WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 13485:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee,
3、was published under the authority of the Standards Committee and comes into effect on 15 March 2001 BSI 03-2001 ISBN 0 580 36992 7 National foreword This British Standard is the official English language version of EN ISO 13485:2000. It is identical with ISO 13485:1996. It supersedes BS EN 46001:199
4、7 which will be withdrawn on 15 February 2004. The UK participation in its preparation was entrusted to Technical Committee CH/66, Quality systems for manufacture of medical devices, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to
5、its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement these international or European
6、 publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. U
7、sers of British Standards are responsible for their correct 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
8、, or proposals for change, and keep the UK interests informed; monitor 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, pa
9、ges ii to iv, pages 1 to 10, the annex ZA page and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Un
10、controlled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13485 November 2000 ICS 03.120.10; 11.040.01 English version Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (revision of EN 46001:1996) (identical to ISO 13485:1996) Syst
11、mes qualit - Dispositifs mdicaux - Exigences particulires relatives lapplication de lEN ISO 9001 (rvision de lEN 46001:1996) (identique lISO 13485:1996) Qualittssicherungssysteme - Medizinprodukte - Besondere Anforderungen fr die Anwendung von EN ISO 9001 (berprfung der EN 46001:1996) (identisch mit
12、 ISO 13485:1996) This European Standard was approved by CEN/CENELEC on 1 April 2000. CEN/CENELEC 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 standard without any alteration. Up-to-date
13、 lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN/CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under
14、 the responsibility of a CEN/CENELEC member into its own language and notified to the Management Centre has the same status as the official versions. CEN/CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium, Czech Republic, Den
15、mark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN Management Centre:CENELEC Central Secretariat: rue de Stassart, 36 B-1050 Brusselsrue de Stassart, 35 B-1050 Brussels 2000 CEN/CENELECAll rig
16、hts of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO 13485:2000 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of the International Standar
17、d from Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices“ of the International Organization for Standardization (ISO) has been taken over as an European Standard by Technical Committee CEN/CENELEC “Coordinating working group on quality supplemen
18、ts“, the secretariat of which is held by DIN. This European Standard supersedes EN 46001:1996. 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 May 2001, and conflicting national standards shall be
19、 withdrawn at the latest by February 2004. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). According to the CEN/CENELEC Internal Regulations, the national
20、 standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endor
21、sement notice The text of the International Standard ISO 13485:1996 has been approved by CEN/CENELEC as a European Standard without any modification. NOTE: Normative references to International Standards are listed in annex ZA (normative). EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na
22、, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled
23、 Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sh
24、effieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT
25、+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 134
26、85:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na
27、, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13485:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled
28、 Copy, (c) BSI Annex ZA (normative) Normative references to international publications with their relevant European publications This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in th
29、e text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to a
30、pplies. Publication Year TitleENYear ISO 84021994 Quality management and quality EN ISO 84021995 assurance - Vocabulary ISO 90011994 Quality systems - Model for quality EN ISO 90011994 assurance in design/development, production, installation and servicing EN ISO 13485:2000 Licensed Copy: sheffieldu
31、n sheffieldun, na, Wed Nov 15 10:48:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 13485:2001 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in
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