1、BSI Standards PublicationBS EN ISO 10993-10:2013Biological evaluation ofmedical devicesPart 10: Tests for irritation and skinsensitizationBS EN ISO 10993-10:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO10993-10:2013. It is identical to ISO 10993-10:20
2、10. It supersedes BSEN ISO 10993-10:2010 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/194, Biological evaluation of medical devices.A list of organizations represented on this committee can beobtained on request to its secretary.This publication d
3、oes not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. 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
4、 obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 28 February 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-10 August 2013 ICS 11.100.20 Supersedes EN ISO 10
5、993-10:2010English 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 sensibilisation cutane (ISO 10993-10:2010) This European Standard was appr
6、oved 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 lists and bibliographical references concerning such national st
7、andards 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 into its own language and
8、 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, Germany, Greece, Hungar
9、y, 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 KOMITEE FR NORMUNG CEN-CENELE
10、C 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: EBS EN ISO 10993-10:2013EN ISO 10993-10:2013 (E) 3 Foreword The text of ISO 10993-10:2010 has been prepa
11、red by Technical Committee ISO/TC 194 “Biological evaluation 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 b
12、y 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 February 2014, and conflicting national standards shall be withdrawn at the latest by February 2014. Attention is drawn to the possibility th
13、at 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 10993-10:2010. This document has been prepared under a mandate given to CEN by the European Co
14、mmission 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 integral parts of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizat
15、ions 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, Luxembourg, Malt
16、a, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, 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. BS EN ISO 10993-10:2013EN ISO 10993-10:2013 (E
17、) 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 a mea
18、ns 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 clau
19、ses 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 Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Stand
20、ard 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/Notes 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 th
21、e 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 and flammability are not covered. 4, 5, 6, 7, 8, Annexes A, B and C
22、 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 provides a means to assess irritancy and skin sensitization to contaminants and residues in medical devices. 4, 5, 6, 7, 8, Annexes A,
23、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 manufacture. However, this standard provides a means to assess irritancy and skin sensitization to substances leaking from medical
24、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 Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 10993-10:2013EN ISO 10993-10:2
25、013 (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 Free Trade As
26、sociation 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 standard in at le
27、ast 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 ZB.1 Corre
28、spondence 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 indents only E
29、R 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 are not cove
30、red. 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. BS EN ISO 10993-10:2013ISO 10993-10:2010(E) IS
31、O 2010 All rights reserved iiiContents Page Foreword iv Introductionvi 1 Scope1 2 Normative references1 3 Terms 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
32、.6 6.1 In vitro irritation tests6 6.2 In vivo irritation tests Factors to be considered in design and selection 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 tes
33、t methods.15 7.2 Murine Local Lymph Node Assay (LLNA).15 7.3 Guinea pig assays for the detection of skin sensitization18 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 te
34、st results26 Annex A (normative) Preparation of materials for irritation/sensitization testing.27 Annex B (normative) 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 preparat
35、ion of extracts from polymeric test materials .54 Annex F (informative) Background information 57 Bibliography61 BS EN ISO 10993-10:2013ISO 10993-10:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standard
36、s 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 that committee. International organiz
37、ations, 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 accordance with the rules given in
38、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 requires approval by at least 75 % o
39、f 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 10993-10 was prepared by Technical Committee ISO/TC 194, Biol
40、ogical 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 Biological evaluation of medical devices: Part 1: Evaluation and testing within
41、 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 cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene
42、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 preparation and reference materials Part 13: Identification and quantifica
43、tion 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 alloys BS EN ISO 10993-10:2013ISO 10993-10:2010(E) ISO 2010 All rights reser
44、ved 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 Spe
45、cification Part 20: Principles and methods for immunotoxicology testing of medical devices Technical Specification BS EN ISO 10993-10:2013ISO 10993-10:2010(E) vi ISO 2010 All rights reservedIntroduction This part of ISO 10993 assesses possible contact hazards from chemicals released from medical dev
46、ices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. Some materials that are included in medical devices have been tested, and their skin or mucosal irritation or sensitization potential has been documented. Other materials and their chemical components have not
47、 been tested and may induce adverse effects when in contact with human tissue. The manufacturer is thus obliged to evaluate each device for potential adverse effects prior to marketing. Traditionally, small animal tests are performed prior to testing on humans to help predict human response. More re
48、cently, in vitro tests as well as human tests have been added as adjuncts or alternatives. Despite progress and considerable effort in this direction, a review of findings suggests that currently no satisfactory in vitro test has been devised to eliminate the requirement for in vivo testing. Where a
49、ppropriate, the preliminary use of in vitro methods is encouraged for screening purposes prior to animal testing. In order to reduce the number of animals used, this part of ISO 10993 presents a step-wise approach, with review and analysis of test results at each stage. An animal test is usually required prior to human testing. It is intended that these studies be conducted using Good Laboratory Practice and comply with regulations related to animal welfare. Statistical analysis of data is recommended and shoul
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