BS EN ISO 10993-12-2012 Biological evaluation of medical devices Sample preparation and reference materials《医疗器械的生物学评价 样品制备和参考材料》.pdf

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1、BSI Standards PublicationBS EN ISO 10993-12:2012Biological evaluation of medical devicesPart 12: Sample preparation and reference materialsBS EN ISO 10993-12:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 10993-12:2012. It supersedes BS EN ISO 10993-12

2、:2009,which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/194, Biological evaluation of medical devices.A list of organizations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 to its secretary.This publication does not purport to include all th

3、e 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 66252 2 ICS 11.100.20 Compliance with a British Standard cannot confer immunity from legal obligations.This British

4、Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2012.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-12 July 2012 ICS 11.100.20 Supersedes EN ISO 10993-12:2009English

5、 Version Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) valuation biologique des dispositifs mdicaux - Partie 12: Prparation des chantillons et matriaux de rfrence (ISO 10993-12:2012) Biologische Beurteilung von Medizinprodukten - T

6、eil 12: Probenvorbereitung und Referenzmaterialien (ISO 10993-12:2012) This European Standard was approved by CEN on 30 June 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 stand

7、ard 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 member. This European Standard exists in three official versions (English, French, German). A version in an

8、y 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 versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Repu

9、blic, 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 United Kingdom. EUROPEAN

10、 COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE 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 10993-12:2012: EBS EN ISO 10

11、993-12:2012 EN ISO 10993-12:2012 (E) 3 Foreword This document (EN ISO 10993-12:2012) has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of medical devices“ in collaboration with Technical Committee CEN/TC 206 “Biological evaluation of medical devices” the secretariat of which

12、 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 January 2013, and conflicting national standards shall be withdrawn at the latest by January 2013. Attention is drawn to the possib

13、ility 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 10993-12:2009. This document has been prepared under a mandate given to CEN by the Eur

14、opean Commission and the European Free Trade Association, and supports essential requirements of EU Directives. For relationship with EU Directives, see informative Annex ZA and ZB, which are an integral parts of this document. According to the CEN/CENELEC Internal Regulations, the national standard

15、s 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxem

16、bourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10993-12:2012 has been approved by CEN as a EN ISO 10993-12:2012 without any modification. BS EN ISO 10993-12:2012EN ISO 10993-12:20

17、12 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide

18、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 has been implemented as a national standard in at least one Member State, compliance with the

19、 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. Table ZA.1 Correspondence between this European Standard and Directive

20、93/42/EEC on medical devices Clauses of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4, 5, 6, 7, 8, 9, 10, 11 7.2 first sentence only This standard provides a means of preparing samples to assess conformity with this part of this ER in conjuncti

21、on with other relevant parts of EN ISO 10993 for the design and manufacture of medical devices. Packaging is not covered. 4, 5, 6, 7, 8, 9, 10 , 11 7.5 first paragraph only This standard provides a means of preparing samples of medical devices to assess conformity with this part of this ER in conjun

22、ction with other relevant parts of EN ISO 10993. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 10993-12:2012 EN ISO 10993-12:2012 (E) 5 Annex ZB (informative) Relationship between this European Standard and

23、 the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices This European 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

24、Approach Directive 90/385/EEC on active implantable medical devices. Once this standard is cited in the Official Journal 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 Tabl

25、e ZB.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. Table ZB.1 Correspondence between this European Standard and Directive 90/385/EEC on active implantable medica

26、l devices Clauses of this European Standard Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/Notes 4, 5, 6, 7, 8, 9, 10, 11 9 (first and second indents only) This standard provides a means of preparing samples of medical devices to assess conformity with these parts of this ER

27、 in conjunction with other relevant parts of EN ISO 10993. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 10993-12:2012ISO 10993-12:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroductio

28、n v1 Scope 12 Normative references . 13 Terms and definitions . 14 General requirements . 35 Reference materials (RMs) 45.1 General . 45.2 Certification of RMs for biological safety testing . 46 Use of RMs as experimental controls 47 Test sample selection . 58 Test sample and RM preparation 59 Selec

29、tion of representative portions from a device . 510 Preparation of extracts of samples 610.1 General . 610.2 Containers for extraction 610.3 Extraction conditions and methods . 610.4 Extraction conditions for hazard identification and risk estimation in the exaggerated-use condition (points to consi

30、der in relation to Annex D) . 911 Records 9Annex A (informative) Experimental controls .10Annex B (informative) General principles on, and practices of, test sample preparation and sample selection 12Annex C (informative) Principles of test sample extraction14Annex D (informative) Exhaustive extract

31、ion of polymeric materials for biological evaluation .17Bibliography .19BS EN ISO 10993-12:2012ISO 10993-12:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standard

32、s 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 that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take

33、part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to

34、prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility tha

35、t 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 10993-12 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.This fourth edition cancels and replaces

36、the third edition (ISO 10993-12:2007), which has been technically revised.ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices: Part 1: Evaluation and testing within a risk management process Part 2: Animal welfare requirements Part 3: Tests for

37、 genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 9: Framework for identification and quantific

38、ation of potential degradation products Part 10: Tests for irritation and skin sensitization Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials Part 13: Identification and quantification of degradation products from polymeric medical devices Part 14: Identificat

39、ion and quantification of degradation products from ceramics Part 15: Identification and quantification of degradation products from metals and alloys Part 16: Toxicokinetic study design for degradation products and leachables Part 17: Establishment of allowable limits for leachable substances Part

40、18: Chemical characterization of materials Part 19: Physico-chemical, morphological and topographical characterization of materials Technical Specification Part 20: Principles and methods for immunotoxicology testing of medical devices Technical Specificationiv ISO 2012 All rights reservedBS EN ISO

41、10993-12:2012ISO 10993-12:2012(E)IntroductionThis part of ISO 10993 specifies methods of sample preparation and provides requirements and guidance for the selection of reference materials for the biological evaluation of medical devices.It is important that sample preparation methods be appropriate

42、for both the biological evaluation methods and the materials being evaluated. Each biological test method requires the selection of materials, extraction solvents and conditions.This part of ISO 10993 is based on existing national and international specifications, regulations and standards wherever

43、possible. It is periodically reviewed and revised. ISO 2012 All rights reserved vBS EN ISO 10993-12:2012BS EN ISO 10993-12:20121 ScopeThis part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materia

44、ls for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, this part of ISO 10993 addresses the following: test sample selection; selection of representative portions from a device; test sample preparation; experimental controls; selection of

45、, and requirements, for reference materials; preparation of extracts.This part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.2 Normative referencesThe following referenced documents are indispensab

46、le 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 10993 (all parts), Biological evaluation of medical devicesISO 14971, Medical devices Applicatio

47、n of risk management to medical devices3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1accelerated extractionextraction that provides a measure of the leachable or extractable materials of the device or material, using conditions that shorten th

48、e time for leaching of the substances into the extraction vehicle but do not result in a chemical change of the substances being extractedEXAMPLE Elevated temperature, agitation, changing of the extraction vehicle.3.2blankextraction vehicle not containing the test material, which is retained in a ve

49、ssel identical to that holding the test sample and subjected to conditions identical to the ones the test sample is subjected to during its extractionNOTE The purpose of the blank is to evaluate possible confounding effects due to the extraction vessel, extraction vehicle and extraction process.INTERNATIONAL STANDARD ISO 10993-12:2012(E) ISO 2012 All rights reserved 1BS EN ISO 10993-12:2012ISO 10993-12:2012(E)3.3CRMcertified reference materialreference material, accompanied by a certificate, one or more of whose property va