EN ISO 13485-2016 en Medical devices - Quality management systems - Requirements for regulatory purposes《医疗器械 质量管理体系 用于监管目的的要求（ISO 13485 2016）》.pdf

1、BSI Standards PublicationMedical devices Qualitymanagement systems Requirements for regulatorypurposesBS EN ISO 13485:2016Incorporating corrigenda March 2016BS EN ISO 13485:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 13485:2016.It supersedes BS EN I

2、SO 13485:2012 which is withdrawn.The UK participation in its preparation was entrusted by TechnicalCommittee CH/210, Quality management and corresponding generalaspects for medical devices, to Subcommittee CH/210/1, Quality systemsfor medical devices.A list of organizations represented on this commi

3、ttee 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 Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 93809 2 ICS 03.120.1

4、0; 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 March 2016.Amendments/corrigenda issued since publicationDate Text affected31 March 2016 CEN Forew

5、ord updated31 March 2016 CEN Foreword and Annexes ZA, ZB and ZC updatedg3g3g3g3g3g3g3g3g3g3g3g3g3g3g3g3 g3g3g3g3g3g3g8g24g21g18g19g8g4g17g3g22g23g4g17g7g4g21g7g3g17g18g21g16g8g3g8g24g21g18g19g50g8g17g17g8g3g8g24g21g18g19g34g12g22g6g11g8g3g17g18g21g16g3EN ISO 13485 g3g3g3 g16g131g148g133g138g3g884g88

6、2g883g888g3g12g6g22g3g882g885g484g883g884g882g484g883g882g482g3g883g883g484g882g886g882g484g882g883g3g22g151g146g135g148g149g135g134g135g149g3g8g17g3g12g22g18g3g883g885g886g890g887g483g884g882g883g884g3g3g3g3g3g3g3g3g3g8g144g137g142g139g149g138g3g152g135g148g149g139g145g144g3g3g16g135g134g139g133g13

7、1g142g3g134g135g152g139g133g135g149g3g486g3g20g151g131g142g139g150g155g3g143g131g144g131g137g135g143g135g144g150g3g149g155g149g150g135g143g149g3g486g3g21g135g147g151g139g148g135g143g135g144g150g149g3g136g145g148g3g148g135g137g151g142g131g150g145g148g155g3g146g151g148g146g145g149g135g149g3g523g12g22g

8、18g3g883g885g886g890g887g483g884g882g883g888g524g3g7g139g149g146g145g149g139g150g139g136g149g3g143g177g134g139g133g131g151g154g3g486g3g22g155g149g150g176g143g135g149g3g134g135g3g143g131g144g131g137g135g143g135g144g150g3g134g135g3g142g131g3g147g151g131g142g139g150g177g3g486g3g8g154g139g137g135g144g13

9、3g135g149g3g157g3g134g135g149g3g136g139g144g149g3g148g177g137g142g135g143g135g144g150g131g139g148g135g149g3g523g12g22g18g3g883g885g886g890g887g483g884g882g883g888g524g3g3 g16g135g134g139g156g139g144g146g148g145g134g151g141g150g135g3g486g3g20g151g131g142g139g150g161g150g149g143g131g144g131g137g135g14

10、3g135g144g150g149g155g149g150g135g143g135g3g486g3g4g144g136g145g148g134g135g148g151g144g137g135g144g3g136g242g148g3g148g135g137g151g142g131g150g145g148g139g149g133g138g135g3g29g153g135g133g141g135g3g523g12g22g18g3g883g885g886g890g887g483g884g882g883g888g524g3g23g138g139g149g3g8g151g148g145g146g135g1

11、31g144g3g22g150g131g144g134g131g148g134g3g153g131g149g3g131g146g146g148g145g152g135g134g3g132g155g3g6g8g17g3g145g144g3g885g882g3g13g131g144g151g131g148g155g3g884g882g883g888g484g3g3g3g6g8g17g3g131g144g134g3g6g8g17g8g15g8g6g3g143g135g143g132g135g148g149g3g131g148g135g3g132g145g151g144g134g3g150g145g3

12、g133g145g143g146g142g155g3g153g139g150g138g3g150g138g135g3g6g8g17g512g6g8g17g8g15g8g6g3g12g144g150g135g148g144g131g142g3g21g135g137g151g142g131g150g139g145g144g149g3g153g138g139g133g138g3g149g150g139g146g151g142g131g150g135g3g150g138g135g3g133g145g144g134g139g150g139g145g144g149g3g136g145g148g3g137g

13、139g152g139g144g137g3g150g138g139g149g3g8g151g148g145g146g135g131g144g3g22g150g131g144g134g131g148g134g3g150g138g135g3g149g150g131g150g151g149g3g145g136g3g131g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g148g134g3g153g139g150g138g145g151g150g3g131g144g155g3g131g142g150g135g148g131g150

14、g139g145g144g484g3g24g146g486g150g145g486g134g131g150g135g3g142g139g149g150g149g3g131g144g134g3g132g139g132g142g139g145g137g148g131g146g138g139g133g131g142g3g148g135g136g135g148g135g144g133g135g149g3g133g145g144g133g135g148g144g139g144g137g3g149g151g133g138g3g144g131g150g139g145g144g131g142g3g149g15

15、0g131g144g134g131g148g134g149g3g143g131g155g3g132g135g3g145g132g150g131g139g144g135g134g3g145g144g3g131g146g146g142g139g133g131g150g139g145g144g3g150g145g3g150g138g135g3g6g8g17g486g6g8g17g8g15g8g6g3g16g131g144g131g137g135g143g135g144g150g3g6g135g144g150g148g135g3g145g148g3g150g145g3g131g144g155g3g6g

16、8g17g3g131g144g134g3g6g8g17g8g15g8g6g3g143g135g143g132g135g148g484g3g3g23g138g139g149g3g8g151g148g145g146g135g131g144g3g22g150g131g144g134g131g148g134g3g135g154g139g149g150g149g3g139g144g3g150g138g148g135g135g3g145g136g136g139g133g139g131g142g3g152g135g148g149g139g145g144g149g3g523g8g144g137g142g139

17、g149g138g481g3g9g148g135g144g133g138g481g3g10g135g148g143g131g144g524g484g3g4g3g152g135g148g149g139g145g144g3g139g144g3g131g144g155g3g145g150g138g135g148g3g142g131g144g137g151g131g137g135g3g143g131g134g135g3g132g155g3g150g148g131g144g149g142g131g150g139g145g144g3g151g144g134g135g148g3g150g138g135g3g

18、148g135g149g146g145g144g149g139g132g139g142g139g150g155g3g145g136g3g131g3g6g8g17g3g131g144g134g3g6g8g17g8g15g8g6g3g143g135g143g132g135g148g3g139g144g150g145g3g139g150g149g3g145g153g144g3g142g131g144g137g151g131g137g135g3g131g144g134g3g144g145g150g139g136g139g135g134g3g150g145g3g150g138g135g3g6g8g17g

19、486g6g8g17g8g15g8g6g3g16g131g144g131g137g135g143g135g144g150g3g6g135g144g150g148g135g3g138g131g149g3g150g138g135g3g149g131g143g135g3g149g150g131g150g151g149g3g131g149g3g150g138g135g3g145g136g136g139g133g139g131g142g3g152g135g148g149g139g145g144g149g484g3g3g6g8g17g3g131g144g134g3g6g8g17g8g15g8g6g3g14

20、3g135g143g132g135g148g149g3g131g148g135g3g150g138g135g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g148g134g149g3g132g145g134g139g135g149g3g131g144g134g3g144g131g150g139g145g144g131g142g3g135g142g135g133g150g148g145g150g135g133g138g144g139g133g131g142g3g133g145g143g143g139g150g150g135g

21、135g149g3g145g136g3g4g151g149g150g148g139g131g481g3g5g135g142g137g139g151g143g481g3g5g151g142g137g131g148g139g131g481g3g6g148g145g131g150g139g131g481g3g6g155g146g148g151g149g481g3g6g156g135g133g138g3g21g135g146g151g132g142g139g133g481g3g7g135g144g143g131g148g141g481g3g8g149g150g145g144g139g131g481g3

22、g9g139g144g142g131g144g134g481g3g9g145g148g143g135g148g3g28g151g137g145g149g142g131g152g3g21g135g146g151g132g142g139g133g3g145g136g3g16g131g133g135g134g145g144g139g131g481g3g9g148g131g144g133g135g481g3g10g135g148g143g131g144g155g481g3g10g148g135g135g133g135g481g3g11g151g144g137g131g148g155g481g3g12g

23、133g135g142g131g144g134g481g3g12g148g135g142g131g144g134g481g3g12g150g131g142g155g481g3g15g131g150g152g139g131g481g3g15g139g150g138g151g131g144g139g131g481g3g15g151g154g135g143g132g145g151g148g137g481g3g16g131g142g150g131g481g3g17g135g150g138g135g148g142g131g144g134g149g481g3g17g145g148g153g131g155g

24、481g3g19g145g142g131g144g134g481g3g19g145g148g150g151g137g131g142g481g3g21g145g143g131g144g139g131g481g3g22g142g145g152g131g141g139g131g481g3g22g142g145g152g135g144g139g131g481g3g22g146g131g139g144g481g3g22g153g135g134g135g144g481g3g22g153g139g150g156g135g148g142g131g144g134g481g3g23g151g148g141g135

25、g155g3g131g144g134g3g24g144g139g150g135g134g3g14g139g144g137g134g145g143g484g3g3g3g3CEN-CENELEC Management Centre:g3Avenue Marnix 17, B-1000 Brussels g825g3g884g882g883g888g3g6g8g17g512g6g8g17g8g15g8g6g3 g4g142g142g3g148g139g137g138g150g149g3g145g136g3g135g154g146g142g145g139g150g131g150g139g145g144

26、g3g139g144g3g131g144g155g3g136g145g148g143g3g131g144g134g3g132g155g3g131g144g155g3g143g135g131g144g149g3g148g135g149g135g148g152g135g134g3g153g145g148g142g134g153g139g134g135g3g136g145g148g3g6g8g17g3g144g131g150g139g145g144g131g142g3g16g135g143g132g135g148g149g3g131g144g134g3g136g145g148g3g6g8g17g8g

27、15g8g6g3g16g135g143g132g135g148g149g484g3g21g135g136g484g3g17g145g484g3g8g17g3g12g22g18g3g883g885g886g890g887g483g884g882g883g888g3g8EN ISO 13485:2016 (E) 3 European foreword This document (EN ISO 13485:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding g

28、eneral aspects for medical devices” in collaboration with Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publicatio

29、n 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 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

30、 not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 13485:2012. This document 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 Directives. F

31、or relationship with EU Directives, see informative Annex ZA, ZB and ZC, which are integral parts of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulg

32、aria, 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, Spain, Sweden, Switzerland, Tu

33、rkey and the United Kingdom. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use

34、 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 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 standar

35、d text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of 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 who

36、le or in part) to which they apply. BS EN ISO 13485:2016g8g17g3g12g22g18g3g883g885g886g890g887g483g884g882g883g888g3g525g8g5264EN ISO 13485:2016 (E) 4 Table 1 Correlation between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equiva

37、lent dated standard EN ISO ISO 9000:2015 EN ISO 9000:2015 ISO 9000:2015 Endorsement notice The text of ISO 13485:2016 has been approved by CEN as EN ISO 13485:2016 without any modification. BS EN ISO 13485:2016g8g17g3g12g22g18g3g883g885g886g890g887g483g884g882g883g888g3g525g8g5265EN ISO 13485:2016 (

38、E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC (as amended) ZA.0 General This European standard has been prepared under a Commissions standardisation request M/023 to provide one voluntary means of conforming to requi

39、rements of Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices OJ L 189. Once this European Standard is cited in the Official Journal of the European Union under Directive 90/385/EEC (as amended) and has been implemen

40、ted as a national standard in at least one Member State, 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 sy

41、stem as given in Annexes 2 and 5 of that Directive and associated EFTA regulations. This Annex ZA explains to which requirements, under which conditions and to what extent presumption of conformity can be claimed. EN ISO 13485:2016 provides requirements for a quality system applicable to medical dev

42、ices. Because this standard describes a quality system that is connected in part or in whole to the conformity assessment requirements of 90/385/EEC (as amended), it is not meaningful to link individual clauses of the standard to specific Essential Requirements. Compliance with all the normative cla

43、uses in EN ISO 13485 will ensure that a process is in place to address quality system aspects related to medical devices, which are included in the conformity assessment annexes of the Directive. However, because this is an adoption of an international standard, intended to be applicable in jurisdic

44、tions all over the world, it is not the primary goal of the standard to cover exactly the European quality system requirements. Therefore, for all of the quality system requirements, conformity is not entirely achieved by complying only with the requirements specified in this standard. Manufacturers

45、 and conformity assessment bodies will need to feed the quality system requirements in the applicable Annex of the Directive into the processes provided by the standard. Explanation on the correspondence of the standard and the requirements of the Directive is included in Tables ZA.1 and ZA.2. The C

46、onformity Assessment Annexes 2 and 5 of the Directive include description of the regulatory process and activities undertaken 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

47、Directive refer to an application to a Notified Body, not to the requirement for a quality system as such. Accordingly, coverage of legal requirements can only be presumed to the extent listed in Tables ZA.1 and ZA.2 in an application to a Notified Body: contains the necessary quality system documen

48、tation; has been reviewed and approved by a Notified Body, and the undertakings listed in the application are correctly executed 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 co

49、mpliance with Directive 98/79/EC, as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. BS EN ISO 13485:2016g8g17g3g12g22g18g3g883g885g886g890g887g483g884g882g883g888g3g525g8g5266EN ISO 13485:2016 (E) 6 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. See EN ISO 14971, Annex ZB for the interpretation