EN ISO 10993-6-2016 en Biological evaluation of medical devices - Part 6 Tests for local effects after implantation《医疗器械生物学评价第6部分 植入后局部反应试验(ISO 10993-6 2016)》.pdf

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1、BS EN ISO 10993-6:2016Biological evaluation ofmedical devicesPart 6: Tests for local effects afterimplantation (ISO 10993-6:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 10993-6:2016 BRITISH STANDARDNational forewordThis British Standard is the UK im

2、plementation of EN ISO 10993-6:2016. It supersedes BS EN ISO 10993-6:2009which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/194, Biological evaluation of medical devices.A list of organizations represented on this committee can be obtained on request t

3、o its 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 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 78685 3 ICS 11.100.20 Compliance with a British Sta

4、ndard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN ISO 10993-6:2016EUROPEAN STANDARD NORME EUROP

5、ENNE EUROPISCHE NORM EN ISO 10993-6 December 2016 ICS 11.100.20 Supersedes EN ISO 10993-6:2009English Version Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016) valuation biologique des dispositifs mdicaux - Partie 6: Essais concernant le

6、s effets locaux aprs implantation (ISO 10993-6:2016) Biologische Beurteilung von Medizinprodukten - Teil 6: Prfungen auf lokale Effekte nach Implantationen (ISO 10993-6:2016) This European Standard was approved by CEN on 4 November 2016. CEN members are bound to comply with the CEN/CENELEC Internal

7、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 on application to the CEN-CENELEC Management Centre or to any CEN

8、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-CENELEC Management Centre has the same status as the official version

9、s. 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, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Pol

10、and, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation

11、 in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10993-6:2016 EBS EN ISO 10993-6:2016EN ISO 10993-6:2016 (E) 2 Contents Page European foreword 3 Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93

12、/42/EEC OJ L 169 aimed to be covered 5 Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC OJ L 189 aimed to be covered . 7 BS EN ISO 10993-6:2016EN ISO 10993-6:2016 (E) 3 European foreword This document (EN ISO 10993-6:2016) has

13、been prepared by Technical Committee ISO/TC 194 “Biological and clinical evaluation of medical devices“ in collaboration with Technical Committee CEN/TC 206 “Biological and clinical evaluation of medical devices” the secretariat of which is held by DIN. This European Standard shall be given the stat

14、us of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2017, and conflicting national standards shall be withdrawn at the latest by June 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject o

15、f patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10993-6:2009. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports

16、 essential requirements of EU Directives. For relationship with EU Directives, see informative Annex ZA and ZB, 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 Eu

17、ropean Standard: 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, S

18、lovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10993-6:2016 has been approved by CEN as EN ISO 10993-6:2016 without any modification. The following referenced documents are indispensable for the application of this document. For undated referen

19、ces, 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, the user should always check that any referenced document has not been superseded and tha

20、t 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 of the IS

21、O 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. BS EN ISO 10993-6:2016EN ISO 10993-6:2016 (E) 4 Table 1 Correlations between undated normative references and date

22、d EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 10993-2 EN ISO 10993-2:2006 ISO 10993-2:2006 ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 ISO 10993-12 EN ISO 10993-1

23、2:2012 ISO 10993-12:2012 ISO 10993-16 EN ISO 10993-16:2010 ISO 10993-16:2010 NOTE This part of EN ISO 10993 refers to ISO 10993-1 which itself refers to ISO 14971. In Europe, it should be assumed that the reference to ISO 14971 is to EN ISO 14971:2012. BS EN ISO 10993-6:2016EN ISO 10993-6:2016 (E) 5

24、 Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions joint standardization request M/BC/CEN/89/9 concerning harmonized standards relating to

25、horizontal aspects in the field of medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under that Directive

26、, compliance with the normative 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 associated EFTA regulations. NOTE 1 Where a reference from a clause o

27、f this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC 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

28、 the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table of

29、references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. BS EN ISO 10993-6:2016EN ISO 10993-6:2016 (E) 6 Table ZA.1 Correspondence between this Euro

30、pean Standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 7.1 (First and second indent) 4, 5, 6 and Annex A, Annex B, Annex C and Annex D This part of ISO 10993 specifies test methods for the assessment of

31、 the local effects after implantation of biomaterials intended for use in medical devices. These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical or functional loading. This part of ISO 10993 does not deal with systemic toxicity,

32、carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects may provide insight into some of these properties. Systemic toxicity studies conducted by implantation may satisfy the requirements of this part of ISO 109

33、93. When conducting combined studies for evaluating local effects and systemic effects, the requirements of this part of ISO 10993 and ISO 10993-11 shall be fulfilled. For ER 7.1 (first and second indent), flammability is not covered 7.2 4, 5, 6 and Annex A, Annex B, Annex C and Annex D 7.5 (First p

34、aragraph) 4, 5, 6 and Annex A, Annex B, Annex C and Annex D General Note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of ISO 10993-1. WARNING 1 Presumption of conformity stays valid only as long as a reference to this European Standard is maintained in th

35、e list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2 Other Union legislation may be applicable to the products falling within the scope of this standard. BS

36、EN ISO 10993-6:2016EN ISO 10993-6:2016 (E) 7 Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC OJ L 189 aimed to be covered This European Standard has been prepared under a Commissions joint standardization request M/BC/CEN/89/9

37、 concerning harmonized standards relating to horizontal aspects in the field of medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable

38、medical devices OJ L 189. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of this standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of conformity with the correspo

39、nding essential requirements of that Directive and associated EFTA regulations. NOTE 1 Where a reference from a clause of this 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 ri

40、sks 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. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements 1, 4, 5,

41、 8, 9 and 10 of the Directive. NOTE 3 This Annex ZB 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 an Essential Requirement does not appear in Table ZB.1, it means that it is not addressed by this

42、 European Standard. BS EN ISO 10993-6:2016EN ISO 10993-6:2016 (E) 8 Table ZB.1 Correspondence between this European Standard and Annex I of Directive 90/385/EEC OJ L 189 Essential Requirements of Directive 90/385/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 9 (only first and second indent) 4

43、, 5, 6 and Annex A, Annex B, Annex C and Annex D This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. These implantation tests are not intended to evaluate or determine the performance of the tes

44、t sample in terms of mechanical or functional loading. This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects may provide insight into some of these

45、properties. Systemic toxicity studies conducted by implantation may satisfy the requirements of this part of ISO 10993. When conducting combined studies for evaluating local effects and systemic effects, the requirements of this part of ISO 10993 and ISO 10993-11 shall be fulfilled. General Note: Pr

46、esumption of conformity depends on also complying with all relevant clauses/subclauses of ISO 10993-1. WARNING 1 Presumption of conformity stays valid only as long as a reference to this European Standard is maintained in the list published in the Official Journal of the European Union. Users of thi

47、s standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2 Other Union legislation may be applicable to the products falling within the scope of this standard. BS EN ISO 10993-6:2016ISO 10993-6:2016(E)Foreword iv1 Scope . 12 Normative refe

48、rences 13 Terms and definitions . 24 Common provisions for implantation test methods . 25 Test methods, general aspects 46 Test report . 96.1 General . 96.2 Test laboratory 96.3 Implant samples 96.4 Animals and implantation . 96.5 Retrieval and histological procedure 106.6 Macroscopic and microscopi

49、c evaluation . 106.7 Final evaluation . 10Annex A (normative) Test methods for implantation in subcutaneous tissue 11Annex B (normative) Test method for implantation in muscle .13Annex C (normative) Test method for implantation in bone .15Annex D (normative) Test method for implantation in brain tissue 18Annex E (informative) Examples of evaluation of local biological effects after implantation .23Bibliography .27 ISO 2016 All rights reserved iiiContents PageBS EN ISO 10993-6:2016ISO 10993-6:2016(E)ForewordISO (the I