EN ISO 10993-7-2008 en Biological evaluation of medical devices - Part 7 Ethylene oxide sterilization residuals《医疗器械的生物评定 第7部分 环氧乙烷消毒残余物》.pdf

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1、BS EN ISO10993-7:2008ICS 11.100.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDBiological evaluationof medical devicesPart 7: Ethylene oxide sterilizationresiduals IncorporatingcorrigendumNovember 2009National forewordThis British Standard is the UK implement

2、ation of EN ISO 10993-7:2008. It is identical to ISO 10993-7:2008, incorporating corrigendum November 2009. It supersedes BS EN ISO 10993-7:1996 which is withdrawn.The start and finish of text introduced or altered by corrigendum is indicated in the text by tags. Text altered by ISO corrigendum Nove

3、mber 2009 is indicated in the text by .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

4、include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN ISO 10993-7:2008This British Standard was published under the authority of the Standards Policy and Strategy Co

5、mmittee on 31 December 2008 BSI 2010Amendments/corrigenda issued since publicationDate Comments 31 July 2010 Implementation of ISO corrigendum November 2009ISBN 978 0 580 70145 0EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10993-7October 2008ICS 11.100.20 Supersedes EN ISO 10993-7:1995 Engl

6、ish VersionBiological evaluation of medical devices - Part 7: Ethylene oxidesterilization residuals (ISO 10993-7:2008)valuation biologique des dispositifs mdicaux - Partie 7:Rsidus de strilisation loxyde dthylne (ISO 10993-7:2008)Biologische Beurteilung von Medizinprodukten - Teil 7:Ethylenoxid- Ste

7、rilisationsrckstnde (ISO 10993-7:2008)This European Standard was approved by CEN on 23 September 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up

8、-to-date lists and bibliographical references concerning such nationalstandards 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 translationunde

9、r the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hun

10、gary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: r

11、ue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10993-7:2008: E3 Foreword This document (EN ISO 10993-7:2008) has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of m

12、edical devices“ in collaboration with 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 status of a national standard, either by publication of an identical text or by endorsement, at the lates

13、t by April 2009, and conflicting national standards shall be withdrawn at the latest by October 2011. 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

14、 patent rights. This document supersedes EN ISO 10993-7:1995. 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 EC Directives. For relationship with EC Directives, see informative An

15、nexes ZA and ZB, which are an integral part of this document. NOTE : The Essential Requirements of the Medical Devices Directives require that risks be reduced or eliminated as far as possible and, specifically, that risks posed by residues be minimized and risks posed by substances leaking from a d

16、evice be reduced to a minimum. It is inherent in these Essential Requirements that, within the maximum limits specified by this standard, exposure to a genotoxic carcinogen should be reduced to levels as low as reasonably practicable, taking account of the generally acknowledged state of the art, th

17、e technological level existing at the time of design and technical and economic considerations compatible with a high level of health and safety. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European St

18、andard: 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 and the United Kingdo

19、m. Endorsement notice The text of ISO 10993-7:2008 has been approved by CEN as a EN ISO 10993-7:2008 without any modification. BS EN ISO 10993-7:2008EN ISO 10993-7:2008 (E)4 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/E

20、EC 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 Approach Directive 93/42/EEC on medical devices. Once this standard i

21、s cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA confers, within the limits of the scope of this standard, a presumption of con

22、formity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA Correspondence between this International Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this International Standard Essential Requirements (ERs) of Direc

23、tive 93/42/EEC Qualifying remarks/Note 4, 5 Annex I, 7.2 and 7.5 For presumption of conformity, the standard needs to be interpreted as explained in the European Foreword. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this Internat

24、ional standard. BS EN ISO 10993-7:2008EN ISO 10993-7:2008 (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 International Standard has been prepared under a mandate given t

25、o 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 standard is cited in the Official Journal of the European Communities under th

26、at Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZB confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Direct

27、ive and associated EFTA regulations. Table ZB Correspondence between this International Standard and Directive 90/385/EEC on active implantable medical devices Clause(s)/sub-clause(s) of this International Standard Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/Note 4, 5 Ann

28、ex I, 9 For presumption of conformity, the standard needs to be interpreted as explained in the European Foreword. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this International standard. BS EN ISO 10993-7:2008EN ISO 10993-7:2008

29、 (E)iiiContents Page Foreword iv Introduction . vi 1 Scope 1 2 Normative references 1 3 Terms and definitions .1 4 Requirements.2 4.1 General2 4.2 Categorization of devices .2 4.3 Allowable limits3 4.4 Determination of EO and ECH residuals .5 5 Product release10 5.1 General10 5.2 Release of products

30、 without dissipation curve data .10 5.3 Procedure for product release using residue dissipation curves 10 Annex A (normative) Evaluation of gas chromatograms12 Annex B (informative) Gas chromatographic determination for EO and ECH15 Annex C (informative) Flowchart and guidance for the application of

31、 this part of ISO 10993 series of standards to the determination of EO and ECH residuals in medical devices.19 Annex D (informative) Factors influencing product residual26 Annex E (informative) Extraction conditions for determination of residual EO .28 Annex F (informative) Rationale for the provisi

32、ons of this part of ISO 10993 29 Annex G (informative) Establishment of allowable limits for EO .33 Annex H (informative) Establishment of allowable limits for ECH.50 Annex I (informative) Establishment of allowable limits for EG.59 Annex J (informative) Preparation of EO and ECH standards63 Annex K

33、 (informative) Ethylene oxide residue measuring methods .67 Bibliography 74 BS EN ISO 10993-7:2008EN ISO 10993-7:2008 (E) ISO 2010 iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing In

34、ternational 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 organizations, governmental and non-governmental, in liaison

35、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 the ISO/IEC Directives, Part 2. The main task of techn

36、ical 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 % of the member bodies casting a vote. Attention is drawn

37、 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 10993-7 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. This second editi

38、on cancels and replaces the first edition (ISO 10993-7:1995) which has been technically revised. ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices: Part 2: Animal welfare requirements Part 3: Tests for genotoxicity, carcinogenicity and reprod

39、uctive 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 quantification of potential degradation products P

40、art 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: Identification and quantification of degradation pro

41、ducts from ceramics Part 15: Identification and quantification of degradation products from metals and alloys Part 1: Evaluation and testing within a risk management process BS EN ISO 10993-7:2008EN ISO 10993-7:2008 (E) ISO 2010v Part 16: Toxicokinetic study design for degradation products and leach

42、ables 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 methods for immunotoxicology testing of m

43、edical devices Technical Specification BS EN ISO 10993-7:2008EN ISO 10993-7:2008 (E) ISO 2010vi Introduction Requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices are given in International Standards developed by ISO/TC 198. C

44、ertain requirements relating to medical devices for biological testing, selection of tests, and the allocation of devices to categories are dealt with in a variety of International Standards developed by ISO/TC 194. The specific requirement for ethylene oxide and other sterilization process residual

45、s was referred to ISO/TC 194. Other International Standards delineate particular requirements for biological testing for specific products. As noted in the introduction to ISO 11135-1:2007, when determining the suitability of ethylene oxide (EO) for sterilization of medical devices, it is important

46、to ensure that the levels of residual EO, ethylene chlorohydrin (ECH) and ethylene glycol (EG) pose a minimal risk to the patient in normal product use. Therefore, it is important that the use of alternative materials and sterilization processes be considered during product design and development. E

47、O is known to exhibit a number of biological effects. In the development of this part of ISO 10993, consideration was given to these effects, which include irritation, organ damage, mutagenicity and carcinogenicity in humans and animals, and reproductive effects in animals. Similar consideration was

48、 given to the harmful effects of ECH and EG. In practice, for most devices, exposure to EO and ECH is considerably lower than the maximum values specified in this part of ISO 10993. Moreover, when the choice for EO sterilization has been made, irrespective of the provisions of this part of ISO 10993

49、, exposure to EO residues should be minimized. Requirements herein are in addition to the biological evaluation and testing requirements for each individually designed medical device as indicated in ISO 10993-1. The biological evaluation and testing requirements, combined with the EO-sterilization process residue limits, form the justification that an EO-sterilized device is acceptable for use. Maximum allowable resi