1、April 2010 Translation by DIN-Sprachendienst.English price group 15No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、11.100.20!$b9“1632261www.din.deDDIN EN ISO 10993-1Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system(ISO 10993-1:2009)English translation of DIN EN ISO 10993-1:2010-04Biologische Beurteilung von Medizinprodukten Teil 1: Beurteilung und Prfungen im
3、 Rahmen eines Risikomanagementsystems(ISO 10993-1:2009)Englische bersetzung von DIN EN ISO 10993-1:2010-04valuation biologique des dispositifs mdicaux Partie 1: valuation et essais au sein dun processus de gestion du risque(ISO 10993-1:2009)Traduction anglaise de DIN EN ISO 10993-1:2010-04Supersedes
4、DIN EN ISO 10993-1:2009-10www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 31 pages04.10 DIN EN ISO 10993-1:2010-04 2 National foreword This standard has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of medical d
5、evices” in collaboration with Technical Committee CEN/TC 206 “Biological evaluation of medical devices” (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Workin
6、g Committee NA 027-02-12 AA Biologische Beurteilung von Medizinprodukten. 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 system Part 2: Animal welfare requirements Part 3: Tests for
7、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 quantifica
8、tion 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: Identificati
9、on 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 1
10、8: 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 Specification DIN EN ISO 10993-1:2010-04 3 The DIN Stan
11、dards corresponding to the International Standards referred to in this document are as follows: ISO 10993-2 DIN EN ISO 10993-2 ISO 10993-3 DIN EN ISO 10993-3 ISO 10993-4 DIN EN ISO 10993-4 ISO 10993-5 DIN EN ISO 10993-5 ISO 10993-6 DIN EN ISO 10993-6 ISO 10993-7 DIN EN ISO 10993-7 ISO 10993-9 DIN EN
12、 ISO 10993-9 ISO 10993-10 DIN EN ISO 10993-10 ISO 10993-11 DIN EN ISO 10993-11 ISO 10993-12 DIN EN ISO 10993-12 ISO 10993-13 DIN EN ISO 10993-13 ISO 10993-14 DIN EN ISO 10993-14 ISO 10993-15 DIN EN ISO 10993-15 ISO 10993-16 DIN EN ISO 10993-16 ISO 10993-17 DIN EN ISO 10993-17 ISO 10993-18 DIN EN ISO
13、 10993-18 ISO 14971 DIN EN ISO 14971 Amendments This standard differs from DIN EN ISO 10993-1:2009-10 as follows: a) Evaluation of existing relevant data from all sources. b) Identification of gaps in the available data set on the basis of a risk analysis. c) Identification of additional data sets n
14、ecessary to analyse the biological safety of the medical device. d) Assessment of the biological safety of the medical device. e) Risk management has been included in the flow chart of the former informative Annex B, which has been transferred to the main text and is now Figure 1 “Summary of the sys
15、tematic approach to a biological evaluation of medical devices as part of a risk management process”. f) Clause 6 (new title:) “Biological evaluation process” has been revised. g) Table 2 “Supplementary evaluation tests for consideration” has been deleted. h) Clause 7 “Interpretation of biological e
16、valuation data and overall biological safety assessment” has been added. i) The former Annex A “Rationale” has been deleted. j) A new Annex A (informative) “Biological evaluation tests” has been included. k) The former Table 1 has been transferred as Table A.1 “Evaluation tests for consideration” in
17、to the new Annex A. l) Annex B (informative) “Guidance on the risk management process” has been included. m) Annex C (informative) “Suggested procedure for literature review” has been included. DIN EN ISO 10993-1:2010-04 4 Previous editions DIN EN 30993-1: 1994-12 DIN EN ISO 10993-1: 1998-06, 2003-1
18、2, 2009-10 DIN EN ISO 10993-1 Corrigendum 1: 1999-06 National Annex NA (informative) Bibliography DIN EN ISO 10993-2, Biological evaluation of medical devices Part 2: Animal welfare requirements DIN EN ISO 10993-3, Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenic
19、-ity and reproductive toxicity DIN EN ISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood DIN EN ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity DIN EN ISO 10993-6, Biological evaluation of medical
20、 devices Part 6: Tests for local effects after implanta-tion DIN EN ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals DIN EN ISO 10993-9, Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential d
21、egradation products DIN EN ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity DIN EN ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity DIN EN ISO 10993-12, Biological evaluation of medical d
22、evices Part 12: Sample preparation and reference materials DIN EN ISO 10993-13, Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices DIN EN ISO 10993-14, Biological evaluation of medical devices Part 14: Identifica
23、tion and quantification of degradation products from ceramics DIN EN ISO 10993-15, Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys DIN EN ISO 10993-16, Biological evaluation of medical devices Part 16: Toxicokinetic s
24、tudy design for degradation products and leachables DIN EN ISO 10993-17, Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances DIN EN ISO 10993-18, Biological evaluation of medical devices Part 18: Chemical characterization of materials DIN EN I
25、SO 14971, Medical devices Application of risk management to medical devices EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-1 October 2009 ICS 11.100.20 Supersedes EN ISO 10993-1:2009, JuneEnglish Version Biological evaluation of medical devices - Part 1: Evaluation and testing within
26、 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 risque (ISO 10993-1:2009) Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prfungen im Rahmen eines Risikomanagementsys
27、tems (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 Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lis
28、ts and bibliographical references concerning such national standards may be obtained on application to the CEN 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 res
29、ponsibility 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 national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
30、Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Av
31、enue 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 10993-1:2009: EContents DIN EN ISO 10993-1:2010-04 EN ISO 10993-1:2009 (E) 2 Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5
32、3 Terms and definitions .6 4 General principles applying to biological evaluation of medical devices.7 5 Categorization of medical devices 10 5.1 General .10 5.2 Categorization by nature of body contact 10 5.3 Categorization by duration of contact.11 6 Biological evaluation process12 6.1 Material ch
33、aracterization 12 6.2 Biological evaluation tests .12 7 Interpretation of biological evaluation data and overall biological safety assessment 18 Annex A (informative) Biological evaluation tests 19 Annex B (informative) Guidance on the risk management process20 Annex C (informative) Suggested proced
34、ure for literature review 23 Bibliography25 Requirements of EU Directive 93/42/EEC on Medical devices .26 Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices27 Annex ZA (informative) Relationship between this European Standard and the Essential Annex ZB (informative) Relati
35、onship between this European Standard and the Essential Foreword of medical devices” the secretariat of which 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 April 2010, and confli
36、cting national standards shall be withdrawn at the latest by April 2010. Attention is drawn to the possibility 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
37、 supersedes EN ISO 10993-1:2009, June. This document has been prepared under a mandate given to CEN by the European 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 ar
38、e 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 European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
39、 Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, 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 an
40、y modification. 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 DIN EN ISO 10993-1:2010-04 EN ISO 10993-1:2009 (E) 3 Introduction The primary
41、 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 Standards and Guidelines concerning the biological evaluation of medical devices. It is intended to be a guidanc
42、e 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 and evaluation of existing data from all sources with, where necessary, the selection and application of a
43、dditional 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 device” is wide-ranging and, at one extreme, consists of a single material, which may exist in more than one ph
44、ysical 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 the effects of medical devices on tissues, mostly in a general way, rather than in a specific device-type s
45、ituation. 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 indicates, in matrices, the biological data sets that are thought to be relevant in the consideration of eac
46、h 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. Thus, in designing a device, the choice of the best material with respect to its tissue interaction might
47、 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 in order to perform its function, the biological evaluation needs to address this. Tissue interactions th
48、at 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 huma
49、ns can be adjudged only with caution, as it cannot be unequivocally concluded that the same tissue reactions will also occur in this species. In addition, differences in the manner of response to the same material among individuals indicate that some patients can have adverse reactions, even to well-established materials. The role of this part of ISO 10993 is to serve as a framework in which to plan a biological evaluation which, as scientific knowledge advances our understanding of the basi
