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 It supersedes BS EN ISO 13485:2003, which will be withdrawn on 31 August 2012.The UK participation in its preparation was entrusted by Technical Committee CH/210, Quality management and corresponding general aspects for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
25、 of EN ISO 13485 is permitted For Annex V, exclusion of 7.3 from EN ISO 13485 is permitted For Annex VII, exclusion of 7.3 from EN ISO 13485 is permitted For Annex VI, exclusion of 7.3, 7.5.1 and 7.5.2 from EN ISO 13485 are permitted It should be noted that where the exclusions described in 1.2 of E
26、N ISO 13485:2012 are exceeded, conformity to EN ISO 13485:2012 shall not be claimed. The requirements in ISO 13485:2003 describe a systematic approach, within which manufacturers can identify, review and decide on the appropriate manner to incorporate regulatory requirements, other standards, and re
27、gulatory guidance documents into their quality management system. In this context, EN ISO 13485 requires the manufacturer to provide quality management system elements including: necessary resources, infrastructure and competent personnel; documentation and records for the operation of the quality m
28、anagement system; systems of internal audit and management review; systems to address nonconformity, corrective action and preventive action. It should be noted that EN ISO 13485:2012 is a quality management system for medical devices specifically for regulatory purposes. It is based on EN ISO 9001:
29、2000 but in particular the requirements for “customer satisfaction” and “continual improvement” have been modified. Therefore, while EN ISO 13485:2012 has the same format as EN ISO 9001:2000 and most of the same requirements, compliance with EN ISO 13485:2012 does not provide conformity with EN ISO
30、9001:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Icela
31、nd, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 13485:2003 has been approved by CEN as a EN ISO 13485:2012 without any modificat
32、ion. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 13485:2012 EN ISO 13485:2012 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Confo
33、rmity Assessment Requirements of EU Directive 90/385/EEC ZA.1 General This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means by which a manufacturer may demonstrate conformity, and by which the Notif
34、ied Body may assess the manufacturers conformity, with the requirements of Directive 90/385/EEC on active implantable medical devices. Within the limits of the scope of this standard (Clause 1 of EN ISO 13485:2012), compliance with the normative clauses of this standard according to the qualifying r
35、emarks presented in Tables ZA.1 and ZA.2 confers presumption of conformity with the requirements on a manufacturers quality system2)as given in Annexes 2 and 5 of that Directive and associated EFTA regulations, once this standard is cited in the Official Journal of the European Union under that Dire
36、ctive and has been implemented as a national standard in at least one Member State. This Annex ZA explains to which requirements, under which conditions and to what extent presumption of conformity can be claimed. The Conformity Assessment Annexes 2 and 5 of the Directive include description of the
37、regulatory process and activities undertaken by the Notified Body, which both are outside of the scope of EN ISO 13485 and therefore not covered by this standard. Furthermore, the requirements of the Directive refer to an application to a Notified Body, not to the requirement for a quality system as
38、 such. Accordingly, coverage of legal requirements can only be presumed to the extent listed in Tables ZA.1 and ZA.2 if an application to a Notified Body: contains the necessary quality system documentation; has been reviewed and approved by a Notified Body, and the undertakings listed in the applic
39、ation are correctly executed by the manufacturer. ZA.2 Relationship with Annex 2 of Directive 90/385/EEC Compliance with EN ISO 13485 does not provide presumption of conformity with all the aspects of Annex 2, as outlined in Table ZA.1. Therefore, a manufacturer or a Notified Body has to take additi
40、onal provisions to ensure conformity, and claim or certify conformance, with Annex 2 of this Directive. The legal requirements must be examined, applied and verified one by one and the solutions adopted must become part of the quality system in the meaning of the Directive. 2)This annex uses the ter
41、m “quality system“ as used in the Directive 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 permitted without license
42、from IHS-,-,-BS EN ISO 13485:2012EN ISO 13485:2012 (E) 6 Table ZA.1 Relationship between Annex 2 of Directive 90/385/EEC and the clauses of EN ISO 13485 Paragraph of Directive 90/385/EEC, Annex 2 Clause(s) of EN ISO 13485 Comments/Qualifying remarks 3.1 first sentence Not covered 3.1 second sentence
43、 1stindent Nt verd3.1 second sentence 2ndindent 4.1, 4.2 Partial coverage: The documentation required in 4.2 of the standard does not cover entirely the quality system documentation meant in 3.2 of Annex 2 unless the explicit legal requirements are incorporated into the quality system documentation.
44、 See also coverage of 3.2 below. 3.1 second sentence 3rdindent Not cverd3.1 second sentence 4thindent Not cverd 3.1 second sentence 5thindent Not cverd 3.2 first paragraph Not covered. The application of EN ISO 13485 does not by itself assure the fulfilment of all regulatory requirements of Directiv
45、e 90/385/EEC. The legal requirements must be examined, applied and verified one by one and the solutions adopted must become part of the quality system in the meaning of the Directive. 3.2 second paragraph, first sentence 4.1, 4.2 Covered 3.2 second paragraph, second sentence 4.1, 4.2 Covered 3.2 se
46、cond paragraph, third sentence Notcv3.2 third paragraph (a) 4.2.1, 5.1, 5.3, 5.4.1 Covered 3.2 third paragraph (b) 4.2.2, 5.1.1 Covered 3.2 third paragraph (b) 1stindent 4.2.2, 5.1, 5.5.1, 5.5.2 Covered 3.2 third paragraph (b) 2ndindent 4.1, 5.6, 7.1, 8.2.2, 8.3, 8.4, 8.5.2, 8.5.3 Covered provided t
47、hat the methods and criteria chosen by the manufacturer ensure that the requirements of the Directive are fulfilled. 3.2 third paragraph (b) 3rdindent 4.1, 7.4, 8.5.1 Covered provided that the processes are documented in accordance with 4.2.1. 3.2 third paragraph (c) 1stindent 4.1, 5.6, 7.1, 8.2.2,
48、8.3, 8.4, 8.5.2, 8.5.3 Covered provided that the methods and criteria chosen by the manufacturer ensure that the requirements of the Directive are fulfilled and there is a description of the standards that will be Copyright European Committee for Standardization Provided by IHS under license with CE
49、NNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 13485:2012 EN ISO 13485:2012 (E) 7 applied. 3.2 third paragraph (c) 2ndindent 7.3.1, 7.3.5, 7.3.6, 7.3.7 Covered 3.2 third paragraph (c) 3rdindent Not cverd 3.2 third paragraph (c) 4thindent Not cverd 3.2 third paragraph (c) 5thindent Not cverd 3.2 third para
