EN ISO 13485-2012 1250 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (Incorporating corrigendum July 2012)《医疗器械 质量管理.pdf
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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 13485:2012Medical devices Quality management systems Requirements for regulatory purposes (ISO 13485:2003)Copyright European Committee for Standardization Provided by I
2、HS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 13485:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 13485:2012. It is identical to ISO 13485:2003, incorporating corrigendum August 2
3、009. It supersedes BS EN ISO 13485:2003, which will be withdrawn on 31 August 2012.The UK participation in its preparation was entrusted by Technical Committee CH/210, Quality management and corresponding general aspects for medical devices, to Subcommittee CH/210/1, Quality systems for medical devi
4、ces.A list of organizations represented on this subcommittee can be obtained on request to its secretary.ISO corrigendum August 2009 added the year of publication to the ISO 9001:2000 references in clauses 0.3, 0.4, 1.1, and Annex B. Reference 6 was also replaced in the bibliography.This publication
5、 does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012Published by BSI Standards Limited 2012ISBN 978 0 580 77860 5 ICS 03.120.10; 11.040.01 Compliance with a British Standard cannot confer im
6、munity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2012.Amendments/corrigenda issued since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under license with CE
7、NNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13485 February 2012 ICS 03.120.10; 11.040.01 Supersedes EN ISO 13485:2003 English version Medical devices - Quality management systems - Requirements for regul
8、atory purposes (ISO 13485:2003) Dispositifs mdicaux - Systmes de manegement de la qualit - Exigences des fins rglementaires (ISO 13485:2003) Medizinprodukte - Qualittsmanagementsysteme - Anforderungen fr regulatorische Zwecke (ISO 13485:2003) This European Standard was approved by CEN on 24 January
9、2012. CEN and 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 bibliographical references concerning such national standards ma
10、y be obtained on application to the CEN-CENELEC Management Centre or to any CEN and 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 of a CEN and CENELEC member into its ow
11、n language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Fra
12、nce, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre, Avenue Marnix 17, B-1000 Brussels 2012 CEN/CENELEC A
13、ll rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO 13485:2012 ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without
14、 license from IHS-,-,-BS EN ISO 13485:2012 EN ISO 13485:2012 (E) 3 Foreword The text of the International Standard ISO 13485:2003 has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices, Working Group 1“. The transposition into a
15、European Standard has been managed by the CEN-CENELEC Management Centre (CCMC) with the assistance of the CEN-CENELEC Technical Committee 3 “Quality Management and corresponding general aspects for medical devices“. This European Standard shall be given the status of a national standard, either by p
16、ublication of an identical text or by endorsement, at the latest by August 2012, and conflicting national standards shall be withdrawn at the latest by August 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELE
17、C shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports quality system requirements of EU Medical Devices Directives. Compliance with E
18、N ISO 13485 does not provide a presumption of conformity with all the aspects of the quality systems of the Medical Devices Directives. It is important that the organization and the Notified Body identify the regulatory requirements that are not covered by the standard. The Annexes Z of this standar
19、d shall be used for this purpose, describing the relationship between this European Standard and the conformity assessment requirements of the Medical Devices Directives. This document supersedes EN ISO 13485:2003. NOTE The following is specifically intended for organizations that need to comply wit
20、h one or more of the European Directives for medical devices (90/385/EEC, 93/42/EEC and 98/79/EC) in order to affix CE marking on their products and for other parties involved in that process whilst other Directives might also require a CE marking. Where organizations wish to implement quality syste
21、ms 1)in conformance with Directives 90/385/EEC, 93/42/EEC and 98/79/EC, they may use EN ISO 13485:2012. EN ISO 13485:2012 provides a framework to enable a manufacturer to meet some of the quality system requirements for an EC Declaration of Conformity (Annex 2 and Annex 5 of Directive 90/385/EEC; An
22、nex II, V and VI of Directive 93/42/EEC; or Annex III, IV and VII of Directive 98/79/EC). In seeking compliance with the quality systems requirements of the Medical Devices Directives, organizations may exclude specific requirements from EN ISO 13485. The table below shows the exclusions that are pe
23、rmitted. 1)The European Directives use the term “quality system“ whereas EN ISO 13485 uses the term “quality management system“ in accordance with ISO terminology. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permi
24、tted without license from IHS-,-,-BS EN ISO 13485:2012EN ISO 13485:2012 (E) 4 Directive 90/385/EEC Directive 93/42/EEC Directive 98/79/EC For Annex 2, no exclusions are permitted For Annex II, no exclusions are permitted For Annex III and IV, no exclusions are permitted For Annex 5, exclusion of 7.3
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