DIN EN ISO 10993-9-2010 Biological evaluation of medical devices - Part 9 Framework for identification and quantification of potential degradation products (ISO 10993-9 2009) Germa.pdf

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1、April 2010 Translation by DIN-Sprachendienst.English price group 11No 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!$b9a“1632262www.din.deDDIN EN ISO 10993-9Biological evaluation of medical devices Part 9: Framework for identification and quantification of potentialdegradation products (ISO 10993-9:2009)English translation of DIN EN ISO 10993-9:2010-04Biologische Beurteilung von Medizinprodukten Teil 9:

3、 Rahmen zur Identifizierung und Quantifizierung von mglichen Abbauprodukten(ISO 10993-9:2009)Englische bersetzung von DIN EN ISO 10993-9:2010-04valuation biologique des dispositifs mdicaux Partie 9: Cadre pour lidentification et la quantification des produits potentiels dedgradation (ISO 10993-9:200

4、9)Traduction anglaise de DIN EN ISO 10993-9:2010-04SupersedesDIN EN ISO 10993-9:2009-08www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 19 pages04.10 DIN EN ISO 10993-9:2010-04 2 National foreword This standard has been prepared by Techn

5、ical Committee ISO/TC 194 “Biological evaluation of medical devices” 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

6、 (Optics and Precision Mechanics Standards Committee), Technical 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 managemen

7、t system 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 oxide sterilizatio

8、n 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 quantification of degradatio

9、n 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 Part 16: Toxicokinetic study design for degradation products and leachables Part 17: Es

10、tablishment 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 methods for immunotoxicology testing of medical devices Te

11、chnical Specification DIN EN ISO 10993-9:2010-04 3 The DIN Standards corresponding to the International Standards referred to in clause 2 of this document are as follows: ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-2 DIN EN ISO 10993-2 ISO 10993-13 DIN EN ISO 10993-13 ISO 10993-14 DIN EN ISO 10993-14 I

12、SO 10993-15 DIN EN ISO 10993-15 Amendments This standard differs from DIN EN ISO 10993-9:2009-08 as follows: a) The scope has been extended to include resorbable and non-resorbable materials. b) A new paragraph in subclause 4.2 informs about extraction conditions and chemical characterization. c) Fi

13、gure A.1 “Flowchart illustrating consideration of the need for degradation studies” has been included. Previous editions DIN EN ISO 10993-9: 1999-10, 2009-08 National Annex NA (informative) Bibliography DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing DIN E

14、N ISO 10993-2, Biological evaluation of medical devices Part 2: Animal welfare requirements 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 me

15、dical devices Part 14: Identification 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 10993-9:2010-04 4 This page is intentional

16、ly blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-9 December 2009 ICS 11.100.20 Supersedes EN ISO 10993-9:2009English Version Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

17、valuation biologique des dispositifs mdicaux - Partie 9: Cadre pour lidentification et la quantification des produits potentiels de dgradation (ISO 10993-9:2009) Biologische Beurteilung von Medizinprodukten - Teil 9: Rahmen zur Identifizierung und Quantifizierung von mglichen Abbauprodukten (ISO 109

18、93-9:2009) This European Standard was approved by CEN on 18 November 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 lists and bibliog

19、raphical 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 responsibility of

20、 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, Iceland, Irela

21、nd, 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: Avenue Marnix 17

22、, 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 10993-9:2009: EContents 2 Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .6 4 Principles for design of degradation

23、 studies .6 4.1 General .6 4.2 Preliminary considerations 7 4.3 Study design 7 4.4 Characterization of degradation products from medical devices8 5 Study report .8 Annex A (normative) Consideration of the need for degradation studies9 Annex B (informative) Biodegradation study considerations11 Bibli

24、ography13 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices .14 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implanta

25、ble Medical Devices15 DIN EN ISO 10993-9:2010-04 EN ISO 10993-9:2009 (E) 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 June

26、2010, and conflicting national standards shall be withdrawn at the latest by June 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

27、. This document supersedes EN ISO 10993-9:2009. 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,

28、 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 this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany

29、, Greece, 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 10993-9:2009 has been approved by CEN as a EN ISO 10993-9:2009 w

30、ithout any modification. 3 This document (EN ISO 10993-9:2009) 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 10993-9:2010-04 EN ISO 10993-9:2009 (E) Introduction Th

31、is part of ISO 10993 is intended to present the general principles on which the specific material investigations to identify and quantify degradation products described in ISO 10993-13 (polymers), ISO 10993-14 (ceramics) and ISO 10993-15 (metals and alloys) are based. Information obtained from these

32、 studies is intended to be used in the biological evaluations described in the remaining parts of ISO 10993. The materials used to construct medical devices can form degradation products when exposed to the biological environment, and in the body these products might behave differently to the bulk m

33、aterial. Mechanical wear causes mostly particulate debris, whereas the release of substances from surfaces due to leaching, chemical breakdown of structures or corrosion can lead to free ions or to different kinds of reaction products in the form of organic or inorganic compounds. The degradation pr

34、oducts can be either reactive or stable and without biochemical reaction with their environment. Accumulations of substantial quantities of stable degradation products can, however, have physical effects on the surrounding tissues. Degradation products might remain at the location of their generatio

35、n or might be transported within the biological environment by various mechanisms. The level of biological tolerability of degradation products depends on their nature and concentration, and should be primarily assessed through clinical experience and focused studies. For theoretically possible, new

36、 and/or unknown degradation products, relevant testing is necessary. For well-described and clinically accepted degradation products, no further investigation may be necessary. Note that the safety and efficacy of a medical device can be compromised as a result of degradation, and the degradation sh

37、ould be considered in the risk management of the device. 4 DIN EN ISO 10993-9:2010-04 EN ISO 10993-9:2009 (E) 1 Scope This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of

38、 biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This part of ISO 10993 considers both non-resorbable and resorbable materials. This part of ISO 10993 is not applicable to: a) evaluation of degradation which

39、occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; NOTE 1 Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this part of IS

40、O 10993, such degradation products can evoke a biological response and thus need to undergo biological evaluation as described in other parts of ISO 10993. b) leachable components which are not degradation products; c) medical devices or components that do not contact the patients body directly or i

41、ndirectly. NOTE 2 This part of ISO 10993 can be applied to the degradation of materials used in any kind of product that falls within the definition of “medical device” in ISO 10993-1, even if such products are subject to different regulations from those applying to medical devices, e.g. the scaffol

42、d in a tissue engineered medical product, or a carrier matrix to deliver drugs or biologics. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edit

43、ion of the referenced document (including any amendments) applies. ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993-2, Biological evaluation of medical devices Part 2: Animal welfare requirements ISO 10993-13, Biological

44、evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices ISO 10993-14, Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics 5 DIN EN ISO 10993-9:2010-04 EN ISO

45、10993-9:2009 (E) ISO 10993-15, Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply. 3.1 deg

46、radation decomposition of a material 3.2 biodegradation degradation (3.1) due to the biological environment 3.3 bioresorbable medical device medical device intended for degradation (3.1) and resorption in the biological environment of the body 3.4 leachable extractable component from a material that

47、 is not a product of degradation 3.5 corrosion attack on metallic materials by chemical or electrochemical reactions NOTE The term is sometimes used in a general sense for the deterioration of other materials but is in this part of ISO 10993 reserved for metallic materials. 3.6 substance single chem

48、ical element or compound, or a complex structure of compounds 3.7 device component one of the different parts of which a device is composed 3.8 degradation product any particle or chemical compound that is derived from the chemical breakdown of the original material 3.9 service environment anatomica

49、l location for the intended use of the device including surrounding fluids, tissues and biomolecules 4 Principles for design of degradation studies 4.1 General The approach to the assessment of degradation varies with the nature of the material under investigation, the medical device and the anatomical location of the specific device. The models chosen for evaluation shall be representative of the service environment of the device. The studies to be conducted do not require a biological environment, b