1、BS EN ISO 13485:2016Medical devices Qualitymanagement systems Requirements for regulatorypurposesBS EN ISO 13485:2016Incorporating corrigendum March 2016Incorporating corrigenda March 2016 and December 2016 (ISO 13485:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 1
2、5:06BS EN ISO 13485:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 13485:2016,The UK participation in its preparation was entrusted by TechnicalCommittee CH/210, Quality management and corresponding generalaspects for medical devices, to Subcommittee C
3、H/210/1, Quality systemsfor medical devices.A list of organizations represented on this subcommittee can be obtainedon request to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application. The British Stand
4、ards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 96770 2 ICS 03.120.10; 11.040.01 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 31 Ma
5、rch 2016.Amendments/corrigenda issued since publicationDate Text affectedincorporating corrigendum December 2016. It supersedes 31 March 2016 CEN Foreword updated31 March 2016 CEN Foreword and Annexes ZA, ZB and ZC updated31 January 2017 Implementation of CEN/CENELEC corrigendum December 2016BS EN I
6、SO 13485:2012 which is withdrawn.The start and finish of text introduced or altered by corrigendum is indicated in the text by tags. Text altered by CEN/CENELEC corrigendumDecember 2016 is indicated in the text by .EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13485 March 2016 ICS 03.120.
7、10; 11.040.01 English version Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)Dispositifs mdicaux - Systmes de management de la qualit - Exigences des fins rglementaires (ISO 13485:2016) Medizinprodukte - Qualittsmanagementsysteme - Anforderungen f
8、r regulatorische Zwecke (ISO 13485:2016) This European Standard was approved by CEN on 30 January 2016. 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
9、 alteration. Up-to-date lists and bibliographical references concerning such national standards may 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 o
10、ther language made by translation under the responsibility of a CEN and CENELEC member into its own 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 committ
11、ees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, S
12、pain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO 13485:2016 EEuropean fo
13、reword This document (EN ISO 13485:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” in collaboration with Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” th
14、e secretariat of which is held by NEN. 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 September 2016, and conflicting national standards shall be withdrawn at the latest by March 2019. Attention
15、is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 13485:2012 and CEN ISO/TR 14969:2005. This document has been pre
16、pared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives. For relationship with EU Directives, see informative Annex ZA, ZB and ZC, which are integral parts of this document. According to the CEN-CENEL
17、EC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Ice
18、land, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. The following referenced documents are indispensable for the application of this document. For undated references
19、, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, ZB and ZC, the user should always check that any referenced document has not been superseded
20、 and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version o
21、f the ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. This document includes the corrigendum EN ISO 13485:2016/AC:2016 which corrects the European foreword, Ann
22、ex ZA, Annex ZB and Annex ZC. EN ISO 13485:2016 (E)BS EN ISO 13485:2016iiTable 1 Correlation between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 9000:2015 EN ISO 9000:2015 ISO 9000:2015 Endors
23、ement notice The text of ISO 13485:2016 has been approved by CEN as EN ISO 13485:2016 without any modification. BS EN ISO 13485:2016EN ISO 13485:2016 (E)iiiAnnex ZA (informative) Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 90/385/EEC (as ame
24、nded) ZA.0 General This European Standard has been prepared under a mandate given to CEN/CENELEC by the European Union and the European Free Trade Association to provide a means by which a manufacturer may demonstrate conformity, and by which the Notified Body may assess the manufacturers conformity
25、, with the requirements of Directive 90/385/EEC (as amended) on active implantable medical devices. Once this European Standard is cited in the Official Journal of the European Union under Directive 90/385/EEC (as amended) and has been implemented as a national standard in at least one Member State,
26、 compliance with the normative clauses of this European Standard given in Table ZA.1 or Table ZA.2 confer, within the limits of the scope of this European Standard, a presumption of conformity with the requirements on a manufacturers quality system as given in Annexes 2 and 5 of that Directive and a
27、ssociated EFTA regulations. This Annex ZA explains to which requirements, under which conditions and to what extent presumption of conformity can be claimed. Deleted text The Conformity Assessment Annexes 2 and 5 of the Directive include description of the regulatory process and activities undertake
28、n by the Notified Body, which both are outside of the scope of this European Standard and therefore not covered by this European Standard. Furthermore, the requirements of the Directive refer to an application to a Notified Body, not to the requirement for a quality system as such. Accordingly, cove
29、rage 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 application are correctly exec
30、uted by the manufacturer. NOTE 1 Where a reference from a clause of this European Standard to the risk management process is made, the risk management process needs to be in compliance with Directive 90/385/EEC, as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, t
31、o a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with essential requirements 1, 4, 5, 8, 9 and 10 of the Directive. Deleted text
32、NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When a requirement does not appear in Table ZA.1 or ZA.2, it means that it is not addressed by this European Standard. NOTE 5 This an
33、nex uses the term “quality system” as used in the Directive whereas this European Standard uses the term “quality management system” in accordance with ISO terminology. EN ISO 13485:2016 (E)BS EN ISO 13485:2016ivZA.1 Relationship with Annex 2 of Directive 90/385/EEC (as amended) Compliance with this
34、 European Standard 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 additional provisions to ensure conformity, and claim or certify conformance, with Annex 2 of this Directive. The legal r
35、equirements 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. Table ZA.1 Correspondence between this European Standard and Annex 2 of Directive 90/385/EEC (as amended) Paragraph of Directive 90/385/EEC,
36、 Annex 2 Clause(s) of this European Standard Comments/Qualifying remarks 3.1, 1st sentence Not covered. 3.1, 2nd sentence, 1st indent Not covered. 3.1, 2nd sentence, 2nd indent 4.1.1, 4.1.2, 4.1.3, 4.1.4, 4.1.6, 4.2.1, 4.2.2, 4.2.3, 4.2.4, 4.2.5 Covered. The documentation required in this European S
37、tandard covers the quality system documentation meant in 3.2 of Annex 2 when the explicit legal requirements are incorporated into the quality system documentation. See also coverage of 3.2 below. 3.1, 2nd sentence, 3rd indent 4.1, 5.1, 5.4, 5.5, 5.6 Covered in part. This European Standard requires
38、top management commitment to implementation of the quality system and that documented procedures are implemented but does not require a signed undertaking. 3.1, 2nd sentence, 4th indent 4.1, 5.1, 5.4, 5.5, 5.6 Covered in part. This European Standard requires maintenance of the approved quality syste
39、m but does not require a signed undertaking. 3.1, 2nd sentence, 5th indent Not covered. This European Standard includes requirements on post-market surveillance, and reporting adverse events and field safety corrective actions to authorities but does not cover all the details required by the Directi
40、ve including timescales for reporting. 3.2, 1st paragraph Not covered. The application of this European Standard does not by itself ensure the fulfilment of all regulatory requirements of the Directive. The legal requirements must be examined, applied and verified one by one and the solutions adopte
41、d become part of the quality system in the meaning of the Directive. 3.2, 2nd paragraph, 1st sentence 4.1, 4.2 Covered. 3.2, 2nd paragraph, 2nd sentence 4.1, 4.2 Covered. 3.2, 2nd paragraph, 3rd sentence 4.1, 4.2, 7 Covered provided quality management system documentation makes possible a uniform in
42、terpretation of the quality policies and procedures, such as quality programs, quality plans, quality manuals and quality records, and that the applicable documentation listed in 3.2 of Annex 2 is incorporated into the quality system documentation. BS EN ISO 13485:2016EN ISO 13485:2016 (E)vParagraph
43、 of Directive 90/385/EEC, Annex 2 Clause(s) of this European Standard Comments/Qualifying remarks 3.2, 3rd paragraph (a) 4.2.1, 4.2.3, 5.1, 5.3, 5.4.1 Covered. 3.2, 3rd paragraph (b) 4.2.2, 5.1 Covered. 3.2, 3rd paragraph (b), 1st indent 4.2.2, 5.1, 5.5.1, 5.5.2 Covered. 3.2, 3rd paragraph (b), 2nd
44、indent 4.1, 5.6, 7.1, 8.2.4, 8.3, 8.4, 8.5.2, 8.5.3 Covered provided that the methods and acceptance criteria chosen by the manufacturer ensure that the requirements of the Directive are fulfilled. 3.2 3rd paragraph (b) 3rd indent 1, 4.1, 4.2, 7.4, 8.2.2 Covered. 3.2 3rd paragraph (c) 1st indent 4.2
45、, 7.3.2, 7.3.3, 7.3.7, 7.3.9, 7.3.10 Covered provided that the applicable quality management system documentation includes design specifications identifying standards which will be applied and a description of the solutions adopted to fulfil the essential requirements which apply when harmonized sta
46、ndards are not applied in full. 3.2, 3rd paragraph (c), 2nd indent 7.3.1, 7.3.6, 7.3.7, 7.3.9 Covered. 3.2, 3rd paragraph (c), 3rd indent Not covered. 3.2, 3rd paragraph (c), 4th indent 7.3.6, 7.3.7 Covered provided that the quality management system records include the pre-clinical evaluation. 3.2,
47、 3rd paragraph (c), 5th indent Not covered. Clause 7.3.7 does not include the details of Annex 7. 3.2, 3rd paragraph (d), 1st indent 4.2, 6.4, 7.1, 7.4 7.5 Covered provided that the quality management system documentation includes relevant documents and records in regards to sterilization and purcha
48、sing. 3.2, 3rd paragraph (d), 2nd indent 4.2, 7.5.8, 7.5.9 Covered. 3.2, 3rd paragraph (e) 4.2, 7.1, 7.4.3, 7.5.9.1, 7.6, 8.2.6 Covered provided that the documented frequency at which tests are carried out is detailed in the quality management system documentation. 6.1 Not covered. The specific time
49、 periods in Directive are not specified in 4.2.4 or 4.2.5. ZA.2 Relationship with Annex 5 of Directive 90/385/EEC (as amended) Compliance with this European Standard does not provide presumption of conformity with all the aspects of Annex 5, as outlined in Table ZA.2. Therefore, a manufacturer or a Notified Body has to take additional provisions to ensure conformity, and claim or certify conformance, with Annex 5 of this Directive. The legal requirements must be examined, applied and verified one by one and the solutions a
