BS-EN-ISO-13488-2001.pdf
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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 13488:2001 The
2、European Standard EN ISO 13488:2000 has the status of a British Standard ICS 03.120.10; 11.040.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Quality systems Medical devices Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical t
3、o ISO 13488:1996) Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee an
4、d comes into effect on 15 March 2001 BSI 03-2001 ISBN 0 580 36991 9 BS EN ISO 13488:2001 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN ISO 13488:2000. It is identical with ISO 13488:1996. It supersedes
5、BS EN 46002:1997 which will be withdrawn on 15 February 2004. The UK participation in its preparation was entrusted to Technical Committee CH/66, Quality systems for the manufacture of medical devices, which has the responsibility to: aid enquirers to understand the text; present to the responsible
6、international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request t
7、o 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 Europe
8、an 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. Use
9、rs of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. 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
10、 title page, pages ii to iv, pages 1 to 9, the annex ZA page, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:07 GMT+00:00 2006, Uncontrolled Copy, (c)
11、 BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13488 November 2000 ICS 03.120.10; 11.040.01 English version Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996) Systmes qualit - Disposi
12、tifs mdicaux - Exigences particulires relatives lapplication de lEN ISO 9002 (rvision de lEN 46002:1996) (identique lISO 13488:1996) Qualittssicherungssysteme - Medizinprodukte - Besondere Anforderungen fr die Anwendung von EN ISO 9002 (berprfung der EN 46002:1996) (identisch mit ISO 13488:1996) Thi
13、s 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 lists and bibliogra
14、phical 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 the responsibility
15、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, Denmark, Finland, Franc
16、e, 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 rights of exploitation
17、in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO 13488:2000 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of the International Standard from Technical Com
18、mittee 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 supplements“, the secretariat
19、 of which is held by DIN. This European Standard supersedes EN 46002:1996. 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 withdrawn at the la
20、test 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 standards organizat
21、ions 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. Endorsement notice The te
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