EN ISO 14630-2012 en Non-active surgical implants - General requirements《稳定的外科植入物 一般要求》.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 It supersedes BS EN ISO 14630:2009, which is withdrawn.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e C H / 1 5 0 , I m p l a n t s f o r s u r g e r y .A list of organizations represented on this committee can be obtained on request to its

3、 secretary.This publication does not purport 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 Standa

4、rd cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2012.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14630 De

5、cember 2012 ICS 11.040.40 Supersedes EN ISO 14630:2009English 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 Europe

6、an Standard was approved by CEN on 30 November 2012. 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 co

7、ncerning such national standards may be obtained 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

8、into its own language and notified to the CEN-CENELEC 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

9、, Germany, Greece, Hungary, Iceland, Ireland, Italy, 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 KOMI

10、TEE FR NORMUNG Management Centre: Avenue Marnix 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 b

11、een prepared by Technical Committee ISO/TC 150 “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 iden

12、tical text or by endorsement, at the latest by June 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 respo

13、nsible for identifying any or all such patent rights. 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

14、with EU Directive(s), see informative Annex ZA, 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, C

15、zech 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, Turkey and the United King

16、dom. Endorsement notice The text of ISO 14630:2012 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 Eu

17、ropean Standard has been prepared under a mandate 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

18、 of the European Union under that Directive and 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 Esse

19、ntial Requirements of that Directive and associated 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,

20、8 and 10 5 7.1 and 7.2 6a 5 a), 5 l), 6 a) and 6 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 7.4 5 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 8.2 10.2 8.3 9.2 8.4 5 g), 8 and 9.3 8.5 9.1

21、and 10.1 8.6 11.2 f) and 11.3 j) 8.7 5 i), 5 j) and 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 t

22、his European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 11.1 13.2 11.2 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)

23、11.2 e) 13.3 m) 11.2 d) and 11.3 d) 13.4 4 and 11.2 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

24、) and t), Indent 3 13.6 k) 11.3 t), Indents 1, 2 and 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 Al

25、l rights reserved iiiContents PageForeword ivIntroduction v1 Scope 12 Normative references . 13 Terms and definitions . 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 surveilla

26、nce . 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 manu

27、facturer . 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)ForewordISO (the International Organization for Standardization) is a worl

28、dwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on

29、that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in

30、 accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard r

31、equires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 14630 was prepared by Techni

32、cal Committee ISO/TC 150, Implants for surgery.This fourth edition cancels and replaces the third edition (ISO 14630:2008), which has been technically revised.iv ISO 2012 All rights reservedBS EN ISO 14630:2012ISO 14630:2012(E)IntroductionThis International Standard provides a method of addressing t

33、he fundamental principles outlined in ISO/TR 14283 as they apply to non-active surgical implants. It also provides a method for demonstrating compliance with the relevant essential requirements as outlined in the general terms in Annex 1 of the European Council Directive 93/42/EEC of 14 June 1993 co

34、ncerning medical devices as they apply to non-active surgical implants, hereafter referred to as implants. It might also help manufacturers comply with the requirements of other regulatory bodies.There are three levels of standards dealing with non-active surgical implants and related instrumentatio

35、n. For the implants themselves, they are as follows, with level 1 being the highest. Level 1: General requirements for non-active surgical implants. Level 2: Particular requirements for families of non-active surgical implants. Level 3: Specific requirements for types of non-active surgical implants

36、.Level 1 standards, such as this International Standard and Reference 4, contain requirements that apply to all non-active surgical implants. They also anticipate that there are additional requirements in the level 2 and level 3 standards.Level 2 standards (see References 5, 6, 7, 8 and 9) apply to

37、a more restricted set or family of non-active surgical implants, such as those designed for use in neurosurgery, cardiovascular surgery, or joint replacement.Level 3 standards (see References 10, 11, 12 and 13) apply to specific types of implants within a family of non-active surgical implants, such

38、 as hip joints or arterial stents.To address all requirements for a specific implant, it is advisable that the standard of the lowest available level be consulted first.NOTE The requirements in this International Standard correspond to international consensus. Individual or national standards or reg

39、ulatory bodies can prescribe other requirements. ISO 2012 All rights reserved vBS EN ISO 14630:2012BS EN ISO 14630:2012Non-active surgical implants General requirements1 ScopeThis International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implant

40、s. This International Standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.With regard to safety, this International Standard specifies requirements for intended perfo

41、rmance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.Additional tests are given or referred to in level 2 and level 3 standards.NOTE This International

42、Standard does not require that the manufacturer have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, might be appropriate to help ensure that the implant achieves its intended performance.2 Normative referencesThe fo

43、llowing referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 8601, Data elements and interchange formats Informat

44、ion interchange Representation of dates and timesISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residualsISO 11135-1, Sterilization of heal

45、th care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization proc

46、ess for medical devicesISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization doseISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO 13408-1, Aseptic proces

47、sing of health care products Part 1: General requirementsISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceISO 14160, Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their

48、 derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devicesISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine cont

49、rol of a sterilization process for medical devicesISO 14971, Medical devices Application of risk management to medical devicesISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devicesINTERNATIONAL STANDARD ISO 14630:2012(E) ISO 2012 All rights reserved 1BS EN ISO 14630:2012ISO 14630:2012(E)ISO 17665-1, Sterilization of health care products Moist heat Part 1: Re