BS EN ISO 10993-10-2013 Biological evaluation of medical devices Tests for irritation and skin sensitization《医疗器械的生物评定 刺激与皮肤过敏症试验》.pdf

1、BSI Standards PublicationBS EN ISO 10993-10:2013Biological evaluation ofmedical devicesPart 10: Tests for irritation and skinsensitizationCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without l

2、icense from IHS-,-,-BS EN ISO 10993-10:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO10993-10:2013. It is identical to ISO 10993-10:2010. It supersedes BSEN ISO 10993-10:2010 which is withdrawn.The UK participation in its preparation was entrusted to T

3、echnicalCommittee CH/194, Biological evaluation of medical devices.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication

4、. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 85495 8ICS 11.100.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on

5、28 February 2014.Amendments issued since publicationDate Text affectedCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NOR

6、M EN ISO 10993-10 August 2013 ICS 11.100.20 Supersedes EN ISO 10993-10:2010English Version Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) valuation biologique des dispositifs mdicaux - Partie 10: Essais dirritation et de sensibilis

7、ation cutane (ISO 10993-10:2010) This European Standard was approved by CEN on 9 July 2013. 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

8、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 any other language made by translation un

9、der 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 Republic, Denmark, Estonia, Finland, Former

10、 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 COMMITTEE FOR STANDARDIZATION COMIT EU

11、ROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10993-10:2013: ECopyright British Standards Institution

12、 Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10993-10:2013EN ISO 10993-10:2013 (E) 3 Foreword The text of ISO 10993-10:2010 has been prepared by Technical Committee ISO/TC 194 “Biological eval

13、uation of medical devices” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 10993-10:2013 by Technical Committee CEN/TC 206 “Biological evaluation of medical devices” the secretariat of which is held by NEN. This European Standard shall be given the statu

14、s of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2014, and conflicting national standards shall be withdrawn at the latest by February 2014. Attention is drawn to the possibility that some of the elements of this document may be the su

15、bject 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 10993-10:2010. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and

16、supports 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

17、 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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slo

18、vakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10993-10:2010 has been approved by CEN as EN ISO 10993-10:2013 without any modification. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy N

19、ot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10993-10:2013EN ISO 10993-10:2013 (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 ha

20、s 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 of the European U

21、nion under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this International Standard given in Table ZA.1 confers, within the limits of the scope of this European Standard, a presumption of conformity with the corresponding

22、 Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Note

23、s 4, 5, 6, 7, 8, Annexes A, B and C 7.1 first and second indents only ER 7.1 is only partly covered by EN ISO 10993-10, since the standard does not provide requirements on design and manufacture. However, this standard provides a means to assess irritancy and skin sensitization to substances used in

24、 the manufacture of medical devices. Other forms of toxicity and flammability are not covered. 4, 5, 6, 7, 8, Annexes A, B and C 7.2 ER 7.2 is only partly covered by EN ISO 10993-10, since the standard does not provide requirements on design, manufacture and packaging. However, this standard provide

25、s a means to assess irritancy and skin sensitization to contaminants and residues in medical devices. 4, 5, 6, 7, 8, Annexes A, B and C 7.5 first sentence of the first paragraph only. ER 7.5 is only partly covered by EN ISO 10993-10, since the standard does not provide requirements on design and man

26、ufacture. However, this standard provides a means to assess irritancy and skin sensitization to substances leaking from medical devices General Note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of EN ISO 10993-1. WARNING Other requirements and other EU Di

27、rectives may be applicable to the product(s) falling within the scope of this standard. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10993-10:2013EN ISO

28、10993-10:2013 (E) 5 Annex ZB (informative) Relationship between this European Standard and 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 Fre

29、e Trade Association to provide a means of conforming to Essential Requirements of the New 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 standar

30、d in at least one Member State, compliance with the clauses of this International Standard given in Table 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

31、ZB.1 Correspondence between this European Standard and Directive 90/385/EEC on Active Implantable Medical Devices Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/Notes 4, 5, 6, 7, 8, Annexes A, B and C 9, first and second inde

32、nts only ER 9 is only partly covered by EN ISO 10993-10, since the standard does not provide requirements on design and manufacture. However, this standard provides a means to assess irritancy and skin sensitization to substances used in the manufacture of medical devices. Other forms of toxicity ar

33、e not covered. General Note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of ISO 10993-1. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. Copyright British Standards Institut

34、ion Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10993-10:2013ISO 10993-10:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introductionvi 1 Scope1 2 Normative references1 3 Te

35、rms and definitions .2 4 General principles Step-wise approach .4 5 Pretest considerations4 5.1 General .4 5.2 Types of material .5 5.3 Information on chemical composition 5 6 Irritation tests.6 6.1 In vitro irritation tests6 6.2 In vivo irritation tests Factors to be considered in design and select

36、ion of in vivo tests 6 6.3 Animal irritation test7 6.4 Animal intracutaneous (intradermal) reactivity test 11 6.5 Human skin irritation test .14 7 Skin sensitization tests.15 7.1 Choice of test methods.15 7.2 Murine Local Lymph Node Assay (LLNA).15 7.3 Guinea pig assays for the detection of skin sen

37、sitization18 7.4 Important factors affecting the outcome of the test 19 7.5 Guinea pig maximization test (GPMT).20 7.6 Closed-patch test (Buehler test) 23 8 Key factors in interpretation of test results26 Annex A (normative) Preparation of materials for irritation/sensitization testing.27 Annex B (n

38、ormative) Special irritation tests29 Annex C (normative) Human skin irritation test 44 Annex D (informative) In vitro tests for skin irritation.48 Annex E (informative) Method for the preparation of extracts from polymeric test materials .54 Annex F (informative) Background information 57 Bibliograp

39、hy61 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10993-10:2013ISO 10993-10:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organi

40、zation for Standardization) is a worldwide 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 establishe

41、d has the right to be represented on 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.

42、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 prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Pub

43、lication as an International Standard requires 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

44、 rights. ISO 10993-10 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. This third edition cancels and replaces the second edition (ISO 10993-10:2002), which has been technically revised. ISO 10993 consists of the following parts, under the general title Biolo

45、gical evaluation of medical devices: Part 1: Evaluation and testing within a risk management process Part 2: Animal welfare requirements Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotox

46、icity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irritation and skin sensitization Part 11: Tests for systemic toxicity Part 12: Sample

47、preparation and reference materials Part 13: Identification and quantification of degradation products from polymeric medical devices Part 14: Identification and quantification of degradation products from ceramics Part 15: Identification and quantification of degradation products from metals and al

48、loys Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10993-10:2013ISO 10993-10:2010(E) ISO 2010 All rights reserved v Part 16: Toxicokinetic study design for degradation products and leachables Part 17: Establishment of allowable limits for leachable substances Part 18: Chemical characterization of materials Part 19: Physico-chemical, morphological and topographical characterization of materials Technical Specification Part 20: Principles and