EN ISO 10993-1-2009 en Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process《医疗器械的生物学评价 第1部分 在风险管理系统内的评价与试验》.pdf

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1、BS EN ISO 10993-1: October 2009ICS 11.100.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDBiological evaluation of medical devicesPart 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)Incorporating corrigenda July 2010 andJune 2010

2、National forewordThis British Standard is the UK implementation of EN ISO 10993-1:October 2009. It is identical with ISO 10993-1:2009, incorporating corrigendum June 2010. It supersedes BS EN ISO 10993-1:June 2009 which is withdrawn.NOTE: CEN issued two standards with the identifier EN ISO 10993-1 i

3、n 2009. The first, published in June 2009 was a revision of EN ISO 10993-1:2003 and reflected the changes to the EU Medical Devices Directive. The second, published in October 2009 was the European implementation of the full revision of ISO 10993-1:2003 and superseded the June 2009 publication, whic

4、h has been withdrawn. BSI has included the month of the CEN publication in the identifier to distinguish between the two editions.The start and finish of text introduced or altered by corrigendum is indicated in the text by tags. Text altered by ISO corrigendum June 2010 is indicated in the text by

5、.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 the necessary provisions o

6、f a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN ISO 10993-1:October 2009This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2010 BSI 2010Ame

7、ndments/corrigenda issued since publicationDate Comments 31 July 2010 Correction to include the CEN month of publication in identifier30 November 2010 Implementation of ISO corrigendum June 2010ISBN 978 0 580 71636 2EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-1 October 2009 ICS 11

8、.100.20 Supersedes EN ISO 10993-1:2009, JuneEnglish Version Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) valuation biologique des dispositifs mdicaux - Partie 1: valuation et essais au sein dun processus de gestion du r

9、isque (ISO 10993-1:2009) Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prfungen im Rahmen eines Risikomanagementsystems (ISO 10993-1:2009) This European Standard was approved by CEN on 17 September 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulatio

10、ns 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 Management Centre or to any CEN member. This Euro

11、pean 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 Management Centre has the same status as the official versions. CEN members are the na

12、tional standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland an

13、d United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10

14、993-1:2009: E3 Foreword This document (EN ISO 10993-1:2009) 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 is held by NEN. This Eur

15、opean Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2010, and conflicting national standards shall be withdrawn at the latest by April 2010. Attention is drawn to the possibility that some of the elemen

16、ts 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 10993-1:2009, June. This document has been prepared under a mandate given to CEN by the European Commission and the

17、 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 organizations of the foll

18、owing countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slo

19、venia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10993-1:2009 has been approved by CEN as a EN ISO 10993-1:2009 without any modification. EN ISO 10993-1:2009 (E) BS EN ISO 10993-1:October 20094 Annex ZA (informative) Relationship between this International

20、 Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices This International 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 Ap

21、proach Directive 93/42/EEC on Medical devices. Once this International 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 International Standard given i

22、n Table ZA.1 confers, within the limits of the scope of this Intenational Standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this International Standard and Directive 93/42/EEC on Me

23、dical devices Clause(s)/subclause(s) of this International Standard Essential Requirements (ERs) of Directive 93/42/EEC on Medical devices Qualifying remarks/notes 4, 5, 6, 7 Annex I: 7.1, 7.2 and 7.5 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling with

24、in the scope of this International Standard. EN ISO 10993-1:2009 (E) BS EN ISO 10993-1:October 2009EN ISO 10993-1:2009 (E) 5 Annex ZB (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices This In

25、ternational 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 90/385/EEC on Active Implantable Medical Devices. Once this International St

26、andard 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 International Standard given in Table ZB.1 confers, within the limits of the scope of this Internationa

27、l 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 Medical Devices Clause(s)/subclause(s) of this Internationa

28、l Standard Essential Requirements (ERs) of Directive 90/385/EEC on Active Implantable Medical Devices Qualifying remarks/notes 4, 5, 6, 7 Annex I: Indents 1 and 2 of Clause 9 only WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this

29、International Standard. BS EN ISO 10993-1:October 2009 ISO 2009 All rights reserved iiiContents Page Foreword iv Introductionvi 1 Scope1 2 Normative references1 3 Terms and definitions .2 4 General principles applying to biological evaluation of medical devices.3 5 Categorization of medical devices

30、6 5.1 General .6 5.2 Categorization by nature of body contact 6 5.3 Categorization by duration of contact.7 6 Biological evaluation process8 6.1 Material characterization 8 6.2 Biological evaluation tests .8 7 Interpretation of biological evaluation data and overall biological safety assessment 14 A

31、nnex A (informative) Biological evaluation tests 15 Annex B (informative) Guidance on the risk management process16 Annex C (informative) Suggested procedure for literature review 19 Bibliography21 BS EN ISO 10993-1:October 2009EN ISO 10993-1:2009 (E)iv ISO 2009 All rights reservedForeword ISO (the

32、International Organization 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

33、 has been established 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 electrotechnic

34、al 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 prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bo

35、dies 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 that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying an

36、y or all such patent rights. ISO 10993-1 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. This fourth edition cancels and replaces the third edition (ISO 10993-1:2003), which has been technically revised. ISO 10993 consists of the following parts, under the g

37、eneral 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 genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests fo

38、r in vitro cytotoxicity 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 toxicit

39、y Part 12: Sample 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

40、from metals and alloys BS EN ISO 10993-1:October 2009EN ISO 10993-1:2009 (E) ISO 2009 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

41、Part 19: Physico-chemical, morphological and topographical characterization of materials (Technical Specification) Part 20: Principles and methods for immunotoxicology testing of medical devices (Technical Specification) Future parts will deal with other relevant aspects of biological evaluation. BS

42、 EN ISO 10993-1:October 2009EN ISO 10993-1:2009 (E)vi ISO 2009 All rights reservedIntroduction The primary aim of this part of ISO 10993 is the protection of humans from potential biological risks arising from the use of medical devices. It is compiled from numerous International and National Standa

43、rds and Guidelines concerning the biological evaluation of medical devices. It is intended to be a guidance document for the biological evaluation of medical devices within a risk management process, as part of the overall evaluation and development of each device. This approach combines the review

44、and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests, thus enabling a full evaluation to be made of the biological responses to each medical device, relevant to its safety in use. It must be appreciated that the term “medical devic

45、e” is wide-ranging and, at one extreme, consists of a single material, which may exist in more than one physical form, and at the other extreme, of a complex instrument or piece of apparatus, consisting of numerous components made of more than one material. ISO 10993 addresses the determination of t

46、he effects of medical devices on tissues, mostly in a general way, rather than in a specific device-type situation. Thus, for a complete biological safety evaluation, it classifies medical devices according to the nature and duration of their anticipated contact with human tissues when in use and in

47、dicates, in matrices, the biological data sets that are thought to be relevant in the consideration of each device category. The range of biological hazards is wide and complex. The tissue interaction with a constituent material alone cannot be considered in isolation from the overall device design.

48、 Thus, in designing a device, the choice of the best material with respect to its tissue interaction might result in a less functional device, tissue interaction being only one of a number of characteristics to be considered in making that choice. Where a material is intended to interact with tissue

49、 in order to perform its function, the biological evaluation needs to address this. Tissue interactions that are regarded as adverse, caused by a material in one application, might not be regarded as such in a different situation. Biological testing is based upon, among other things, in vitro and ex vivo test methods and upon animal models, so that the anticipated behaviour when a device is used in humans can be adjudged only with caution, as it cannot be unequivocally concluded that the same tissue reactions wil