BS EN ISO 14630-2012 Non-active surgical implants General requirements《非有源外科植入物 通用要求》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 14630:2012Non-active surgical implants General requirementsBS EN ISO 14630:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN IS

2、O 14630:2012. It supersedes BS EN ISO 14630:2009, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150, Implants for surgery.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not p

3、urport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012.ISBN 978 0 580 78731 7 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal o

4、bligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14630 December 2012 ICS 11.040.40 Supersedes EN ISO 1463

5、0:2009English Version Non-active surgical implants - General requirements (ISO 14630:2012) Implants chirurgicaux non actifs - Exigences gnrales (ISO 14630:2012) Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2012) This European Standard was approved by CEN on 30 November 2

6、012. CEN 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 may be obtained

7、 on application to the CEN-CENELEC Management Centre or to any CEN 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 member into its own language and notified to the CEN-CE

8、NELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, It

9、aly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix

10、17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14630:2012: EBS EN ISO 14630:2012 EN ISO 14630:2012 (E) 3 Foreword This document (EN ISO 14630:2012) has been prepared by Technical Committee ISO/TC 150 “

11、Implants for surgery“ in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. 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 J

12、une 2013, and conflicting national standards shall be withdrawn at the latest by June 2013. 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 not be held responsible for identifying any or all such patent ri

13、ghts. This document supersedes EN ISO 14630:2009. 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 Directive(s). For relationship with EU Directive(s), see informative Annex ZA,

14、which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former

15、 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, Turkey and the United Kingdom. Endorsement notice The text of ISO 14630:20

16、12 has been approved by CEN as a EN ISO 14630:2012 without any modification. BS EN ISO 14630:2012EN ISO 14630:2012 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandat

17、e given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and

18、has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associa

19、ted EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 1, 2nd indent 4, 5, 8 and 10 5 7.1 and 7.2 6a 5 a), 5 l), 6 a) and 6

20、 b) 7.1, 1st indent 5 a), 6 a) and 6 b) 7.1, 2nd indent 7.2 c) 7.1, 3rd indent 5 f), 5 r), 7, 8 and 10 7.2 5 h) and 6 7.3 6 7.45 d), 5 e) and 6 7.5 5 b), 5 f), 5 m) and 6 7.6 5 q), 6, 8, 9.1 and 10.1 8.1 6 8.210.2 8.3 9.2 8.4 5 g), 8 and 9.3 8.5 9.1 and 10.1 8.6 11.2 f) and 11.3 j) 8.7 5 i), 5 j) an

21、d 11.4 9.1 5 b), 5 k), 6 and 7.1 9.2, 1st indent 5 n), 6 and 7.1 9.2, 2nd indent 5 n) 9.2, 3rd indent 5 c), 5 d) and 6 9.2, 4th indent 11.1, 11.2, 11.3 b), g), h) and 11.5 13.1 BS EN ISO 14630:2012 EN ISO 14630:2012 (E) 5 Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs)

22、 of Directive 93/42/EEC Qualifying remarks/Notes 11.1 13.211.2 b) 13.3 a) 11.2 c) and 11.2 d) 13.3 b) 11.2 e) 13.3 c) 11.2 c) 13.3 d) 11.2 g) 13.3 e) 11.2 h) 13.3 f) 11.6 13.3 g) 11.6 13.3 h) 10.1 and 11.2 j) 13.3 i) 11.2 j) 13.3 j) 11.2 k) 13.3 k) 11.2 e) 13.3 m) 11.2 d) and 11.3 d) 13.4 4 and 11.2

23、 c) 13.5 11.3 b), c), d), i), m), n) and 11.6 13.6 a) 11.3 e) 13.6 b) 11.3 f) and 11.4 13.6 c) 11.3 h) 13.3 d) 11.3 g) and o) 13.6 e) 11.3 q), r) and t), Indent 5 13.6 f) 9.3.2, 10.2 and 11.3 l) 13.6 g) 9.3 and 11.2 k) 13.6 i) 11.3 a) 13.6 j) 11.3 b) and t), Indent 3 13.6 k) 11.3 t), Indents 1, 2 an

24、d 4 13.6 l) 11.3 t), Indent 6 13.6 m) 11.3 s) 13.6 n) 11.3 u) 13.6 q) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 14630:2012ISO 14630:2012(E) ISO 2012 All rights reserved iiiContents g51g68g74g72Foreword

25、ivIntroduction v1 Scope 12 Normative references . 1g22g3 g55g72g85g80g86g3g68g81g71g3g71g72g191g81g76g87g76g82g81g86 . 24 Intended performance 35 Design attributes . 36 Materials . 47 Design evaluation 57.1 General . 57.2 Pre-clinical evaluation 57.3 Clinical evaluation . 67.4 Post-market surveillan

26、ce . 68 Manufacture 69 Sterilization . 69.1 General . 69.2 Products supplied sterile 69.3 Sterilization by the user . 79.4 Sterilization residuals . 710 Packaging 710.1 Protection from damage in storage and transport . 710.2 Maintenance of sterility in transit . 711 Information supplied by the manuf

27、acturer . 811.1 General . 811.2 Labelling 811.3 Instructions for use . 911.4 Restrictions on combinations 1011.5 Marking on implants .1011.6 Marking for special purposes 11Bibliography .12BS EN ISO 14630:2012ISO 14630:2012(E)Forewordg44g54g50g3g11g87g75g72g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g

28、50g85g74g68g81g76g93g68g87g76g82g81g3g73g82g85g3g54g87g68g81g71g68g85g71g76g93g68g87g76g82g81g12g3g76g86g3g68g3g90g82g85g79g71g90g76g71g72g3g73g72g71g72g85g68g87g76g82g81g3g82g73g3g81g68g87g76g82g81g68g79g3g86g87g68g81g71g68g85g71g86g3g69g82g71g76g72g86g3g11g44g54g50g3 g80g72g80g69g72g85g3 g69g82g71

29、g76g72g86g12g17g3 g55g75g72g3 g90g82g85g78g3 g82g73g3 g83g85g72g83g68g85g76g81g74g3 g44g81g87g72g85g81g68g87g76g82g81g68g79g3 g54g87g68g81g71g68g85g71g86g3 g76g86g3 g81g82g85g80g68g79g79g92g3 g70g68g85g85g76g72g71g3 g82g88g87g3 g87g75g85g82g88g74g75g3 g44g54g50g3g87g72g70g75g81g76g70g68g79g3g70g82g8

30、0g80g76g87g87g72g72g86g17g3g40g68g70g75g3g80g72g80g69g72g85g3g69g82g71g92g3g76g81g87g72g85g72g86g87g72g71g3g76g81g3g68g3g86g88g69g77g72g70g87g3g73g82g85g3g90g75g76g70g75g3g68g3g87g72g70g75g81g76g70g68g79g3g70g82g80g80g76g87g87g72g72g3g75g68g86g3g69g72g72g81g3g72g86g87g68g69g79g76g86g75g72g71g3g75g68

31、g86g3g87g75g72g3g85g76g74g75g87g3g87g82g3g69g72g3g85g72g83g85g72g86g72g81g87g72g71g3g82g81g3g87g75g68g87g3g70g82g80g80g76g87g87g72g72g17g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g82g85g74g68g81g76g93g68g87g76g82g81g86g15g3g74g82g89g72g85g81g80g72g81g87g68g79g3g68g81g71g3g81g82g81g16g74g82g89g72g85g

32、81g80g72g81g87g68g79g15g3g76g81g3g79g76g68g76g86g82g81g3g90g76g87g75g3g44g54g50g15g3g68g79g86g82g3g87g68g78g72g3g83g68g85g87g3g76g81g3g87g75g72g3g90g82g85g78g17g3g44g54g50g3g70g82g79g79g68g69g82g85g68g87g72g86g3g70g79g82g86g72g79g92g3g90g76g87g75g3g87g75g72g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3

33、g40g79g72g70g87g85g82g87g72g70g75g81g76g70g68g79g3g38g82g80g80g76g86g86g76g82g81g3g11g44g40g38g12g3g82g81g3g68g79g79g3g80g68g87g87g72g85g86g3g82g73g3g72g79g72g70g87g85g82g87g72g70g75g81g76g70g68g79g3g86g87g68g81g71g68g85g71g76g93g68g87g76g82g81g17g44g81g87g72g85g81g68g87g76g82g81g68g79g3g54g87g68g81

34、g71g68g85g71g86g3g68g85g72g3g71g85g68g73g87g72g71g3g76g81g3g68g70g70g82g85g71g68g81g70g72g3g90g76g87g75g3g87g75g72g3g85g88g79g72g86g3g74g76g89g72g81g3g76g81g3g87g75g72g3g44g54g50g18g44g40g38g3g39g76g85g72g70g87g76g89g72g86g15g3g51g68g85g87g3g21g17g55g75g72g3g80g68g76g81g3g87g68g86g78g3g82g73g3g87g72

35、g70g75g81g76g70g68g79g3g70g82g80g80g76g87g87g72g72g86g3g76g86g3g87g82g3g83g85g72g83g68g85g72g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g54g87g68g81g71g68g85g71g86g17g3g39g85g68g73g87g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g54g87g68g81g71g68g85g71g86g3g68g71g82g83g87g72g71g3g69g92g3g87g75g72g3g87g

36、72g70g75g81g76g70g68g79g3g70g82g80g80g76g87g87g72g72g86g3g68g85g72g3g70g76g85g70g88g79g68g87g72g71g3g87g82g3g87g75g72g3g80g72g80g69g72g85g3g69g82g71g76g72g86g3g73g82g85g3g89g82g87g76g81g74g17g3g51g88g69g79g76g70g68g87g76g82g81g3g68g86g3g68g81g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g54g87g68g81g71

37、g68g85g71g3g85g72g84g88g76g85g72g86g3g68g83g83g85g82g89g68g79g3g69g92g3g68g87g3g79g72g68g86g87g3g26g24g3g8g3g82g73g3g87g75g72g3g80g72g80g69g72g85g3g69g82g71g76g72g86g3g70g68g86g87g76g81g74g3g68g3g89g82g87g72g17g36g87g87g72g81g87g76g82g81g3g76g86g3g71g85g68g90g81g3g87g82g3g87g75g72g3g83g82g86g86g76g6

38、9g76g79g76g87g92g3g87g75g68g87g3g86g82g80g72g3g82g73g3g87g75g72g3g72g79g72g80g72g81g87g86g3g82g73g3g87g75g76g86g3g71g82g70g88g80g72g81g87g3g80g68g92g3g69g72g3g87g75g72g3g86g88g69g77g72g70g87g3g82g73g3g83g68g87g72g81g87g3g85g76g74g75g87g86g17g3g44g54g50g3g86g75g68g79g79g3g81g82g87g3g69g72g3g75g72g79g

39、71g3g85g72g86g83g82g81g86g76g69g79g72g3g73g82g85g3g76g71g72g81g87g76g73g92g76g81g74g3g68g81g92g3g82g85g3g68g79g79g3g86g88g70g75g3g83g68g87g72g81g87g3g85g76g74g75g87g86g17g44g54g50g3g20g23g25g22g19g3g90g68g86g3g83g85g72g83g68g85g72g71g3g69g92g3g55g72g70g75g81g76g70g68g79g3g38g82g80g80g76g87g87g72g72g

40、3g44g54g50g18g55g38g3g20g24g19g15g3Implants for surgery.g55g75g76g86g3g73g82g88g85g87g75g3g72g71g76g87g76g82g81g3g70g68g81g70g72g79g86g3g68g81g71g3g85g72g83g79g68g70g72g86g3g87g75g72g3g87g75g76g85g71g3g72g71g76g87g76g82g81g3g11g44g54g50g3g20g23g25g22g19g29g21g19g19g27g12g15g3g90g75g76g70g75g3g75g68g

41、86g3g69g72g72g81g3g87g72g70g75g81g76g70g68g79g79g92g3g85g72g89g76g86g72g71g17iv ISO 2012 All rights reserved BS EN ISO 14630:2012ISO 14630:2012(E)Introductiong55g75g76g86g3 g44g81g87g72g85g81g68g87g76g82g81g68g79g3 g54g87g68g81g71g68g85g71g3 g83g85g82g89g76g71g72g86g3 g68g3 g80g72g87g75g82g71g3 g82g

42、73g3 g68g71g71g85g72g86g86g76g81g74g3 g87g75g72g3 g73g88g81g71g68g80g72g81g87g68g79g3 g83g85g76g81g70g76g83g79g72g86g3 g82g88g87g79g76g81g72g71g3 g76g81g3g44g54g50g18g55g53g3 g20g23g21g27g22g3 g68g86g3 g87g75g72g92g3 g68g83g83g79g92g3 g87g82g3 g81g82g81g16g68g70g87g76g89g72g3 g86g88g85g74g76g70g68g7

43、9g3 g76g80g83g79g68g81g87g86g17g3 g44g87g3 g68g79g86g82g3 g83g85g82g89g76g71g72g86g3 g68g3 g80g72g87g75g82g71g3 g73g82g85g3 g71g72g80g82g81g86g87g85g68g87g76g81g74g3g70g82g80g83g79g76g68g81g70g72g3g90g76g87g75g3g87g75g72g3g85g72g79g72g89g68g81g87g3g72g86g86g72g81g87g76g68g79g3g85g72g84g88g76g85g72g8

44、0g72g81g87g86g3g68g86g3g82g88g87g79g76g81g72g71g3g76g81g3g87g75g72g3g74g72g81g72g85g68g79g3g87g72g85g80g86g3g76g81g3g36g81g81g72g91g3g20g3g82g73g3g87g75g72g3g40g88g85g82g83g72g68g81g3g38g82g88g81g70g76g79g3g39g76g85g72g70g87g76g89g72g3g28g22g18g23g21g18g40g40g38g3g82g73g3g20g23g3g45g88g81g72g3g20g28

45、g28g22g3g70g82g81g70g72g85g81g76g81g74g3g80g72g71g76g70g68g79g3g71g72g89g76g70g72g86g3g68g86g3g87g75g72g92g3g68g83g83g79g92g3g87g82g3g81g82g81g16g68g70g87g76g89g72g3g86g88g85g74g76g70g68g79g3g76g80g83g79g68g81g87g86g15g3g75g72g85g72g68g73g87g72g85g3g85g72g73g72g85g85g72g71g3g87g82g3g68g86g3g76g80g83

46、g79g68g81g87g86g17g3g44g87g3g80g76g74g75g87g3g68g79g86g82g3g75g72g79g83g3g80g68g81g88g73g68g70g87g88g85g72g85g86g3g70g82g80g83g79g92g3g90g76g87g75g3g87g75g72g3g85g72g84g88g76g85g72g80g72g81g87g86g3g82g73g3g82g87g75g72g85g3g85g72g74g88g79g68g87g82g85g92g3g69g82g71g76g72g86g17g55g75g72g85g72g3g68g85g7

47、2g3g87g75g85g72g72g3g79g72g89g72g79g86g3g82g73g3g86g87g68g81g71g68g85g71g86g3g71g72g68g79g76g81g74g3g90g76g87g75g3g81g82g81g16g68g70g87g76g89g72g3g86g88g85g74g76g70g68g79g3g76g80g83g79g68g81g87g86g3g68g81g71g3g85g72g79g68g87g72g71g3g76g81g86g87g85g88g80g72g81g87g68g87g76g82g81g17g3g41g82g85g3g87g75g

48、72g3g76g80g83g79g68g81g87g86g3g87g75g72g80g86g72g79g89g72g86g15g3g87g75g72g92g3g68g85g72g3g68g86g3g73g82g79g79g82g90g86g15g3g90g76g87g75g3g79g72g89g72g79g3g20g3g69g72g76g81g74g3g87g75g72g3g75g76g74g75g72g86g87g17g178g3 g47g72g89g72g79g3g20g29g3g42g72g81g72g85g68g79g3g85g72g84g88g76g85g72g80g72g81g87

49、g86g3g73g82g85g3g81g82g81g16g68g70g87g76g89g72g3g86g88g85g74g76g70g68g79g3g76g80g83g79g68g81g87g86g17g178g3 g47g72g89g72g79g3g21g29g3g51g68g85g87g76g70g88g79g68g85g3g85g72g84g88g76g85g72g80g72g81g87g86g3g73g82g85g3g73g68g80g76g79g76g72g86g3g82g73g3g81g82g81g16g68g70g87g76g89g72g3g86g88g85g74g76g70g68g79g3g76g80g83g79g68g81g87g86g17g178g3 g47g72g89g72g79g3g22g29g3g54g83g72g70g76g191g70g3g85g72g84g88g76g85g72g80g72g81g87g86g3g73g82g85g3g87g92g8