DIN EN ISO 10993-7-2009 Biological evaluation of medical devices - Part 7 Ethylene oxide sterilization residuals (ISO 10993-7 2008) English version of DIN EN ISO 10993-7 2009-02《医疗.pdf

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1、February 2009DEUTSCHE NORM English price group 31No part of this standard 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 11.100.20!$Uvb“150836

2、3www.din.deDDIN EN ISO 10993-7Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)English version of DIN EN ISO 10993-7:2009-02Biologische Beurteilung von Medizinprodukten Teil 7: Ethylenoxid-Sterilisationsrckstnde (ISO 10993-7:2008)Englische Fas

3、sung DIN EN ISO 10993-7:2009-02SupersedesDIN EN ISO 10993-7:1995-11www.beuth.deDocument comprises 96 pages2 National foreword This standard has been published in accordance with a decision taken by Technical Committee CEN/TC 206 “Biological evaluation of medical devices” (Secretariat: NEN, Netherlan

4、ds) to adopt, without alteration, International Standard ISO 10993-7:2008 as a European Standard. ISO 10993-7:2008 was prepared by Technical Committee ISO/TC 194 “Biological evaluation of medical devices”. The responsible German body involved in its preparation was the Normenausschuss Feinmechanik u

5、nd Optik (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 m

6、anagement 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 ster

7、ilization 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 de

8、gradation 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 Par

9、t 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 medical de

10、vices Technical Specification DIN EN ISO 10993-7:2009-02 3 The DIN Standards corresponding to the International Standards referred to in clause 2 of the EN are as follows: ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-3 DIN EN ISO 10993-3 ISO 10993-10 DIN EN ISO 10993-10 ISO 10993-12 DIN EN ISO 10993-12

11、ISO 10993-17 DIN EN ISO 10993-17 Amendments This standard differs from DIN EN 10993-7:1995-11 as follows: a) Subclause 4.3.5 relating to tolerable contact limits for ethylene oxide (EO) for surface contacting devices and implants has been added. b) A new Annex C relating to the determination of EO r

12、esiduals in medical devices has been included. c) A new Annex G relating to the establishment of allowable limits for EO has been included. d) A new Annex H relating to the establishment of allowable limits for ethylene chlorohydrin (ECH) has been included. e) A new Annex I relating to the establish

13、ment of allowable limits for ethylene glycol (EG) has been included. f) A new Annex J relating to the preparation of EO and ECH standards has been included. g) A new Annex K relating to ethylene oxide residue measuring methods has been included. h) Annex ZA (informative) “Relationship between this E

14、uropean Standard and the Essential Requirements of EU Directive 93/42/EEC Medical devices” has been added. i) Annex ZB (informative) “Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices” has been added. Previous

15、editions DIN EN ISO 10993-7: 1995-11 DIN EN ISO 10993-7:2009-02 4 National Annex NA (informative) Bibliography DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing DIN EN ISO 10993-3, Biological evaluation of medical devices Part 3: Tests for genotoxicity, carc

16、inogenicity and reproductive toxicity DIN EN ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity DIN EN ISO 10993-12, Biological evaluation of medical devices Part 12: Sample preparation and reference materials DIN EN ISO 10993-17, B

17、iological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances DIN EN ISO 10993-7:2009-02 EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10993-7October 2008ICS 11.100.20 Supersedes EN ISO 10993-7:1995 English VersionBiological evaluation of medical

18、 devices - Part 7: Ethylene oxidesterilization residuals (ISO 10993-7:2008)valuation biologique des dispositifs mdicaux - Partie 7:(ISO 10993-7:2008)Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid-Sterilisationsrckstnde (ISO 10993-7:2008)This European Standard was approved by CEN

19、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-to-date lists and bibliographical references concerning such nationalstandards m

20、ay 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 translationunder the responsibility of a CEN member into its own language and notified to the CE

21、N 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,

22、 Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any for

23、m and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10993-7:2008: ERsidus de strilisation loxyde dthylne Contents Page Foreword 3 Introduction . 4 1 Scope 5 2 Normative references 5 3 Terms and definitions . 5 4 Requirements. 6 4.1 General 6 4.2 Categorization of devices .

24、6 4.3 Allowable limits 7 4.4 Determination of EO and ECH residuals . 9 5 Product release14 5.1 General14 5.2 Release of products without dissipation curve data .14 5.3 Procedure for product release using residue dissipation curves 14 Annex A (normative) Evaluation of gas chromatograms16 Annex B (inf

25、ormative) Gas chromatographic determination for EO and ECH19 Annex C (informative) Flowchart and guidance for the application of this part of ISO 10993 series of standards to the determination of EO and ECH residuals in medical devices.23 Annex D (informative) Factors influencing product residual30

26、Annex E (informative) Extraction conditions for determination of residual EO .32 Annex F (informative) Rationale for the provisions of this part of ISO 10993 33 Annex G (informative) Establishment of allowable limits for EO .37 Annex H (informative) Establishment of allowable limits for ECH.54 Annex

27、 I (informative) Establishment of allowable limits for EG.63 Annex J (informative) Preparation of EO and ECH standards67 Annex K (informative) Ethylene oxide residue measuring methods .71 Bibliography 80 Requirements of EU Directive 93/42/EEC Medical devices .78 Requirements of EU Directive 90/385/E

28、EC on Active Implantable Medical Devices .79 Annex ZA (informative) Relationship between this International Standard and the Essential Annex ZB (informative) Relationship between this International Standard and the Essential 2DIN EN ISO 10993-7:2009-02 EN ISO 10993-7:2008 (E)Foreword This document (

29、EN ISO 10993-7:2008) 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 European Standard shall be given the status

30、of a national standard, either by publication of an identical text or by endorsement, at the latest 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

31、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 10993-7:1995. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and support

32、s essential requirements of EC Directives. For relationship with EC Directives, see informative Annexes 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, spec

33、ifically, that risks posed by residues be minimized and risks posed by substances leaking from a device 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 a

34、s low as reasonably practicable, taking account of the generally acknowledged state of the art, the 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 n

35、ational 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norwa

36、y, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10993-7:2008 has been approved by CEN as a EN ISO 10993-7:2008 without any modification. “”3DIN EN ISO 10993-7:2009-02 EN ISO 10993-7:2008 (E)Introduction Requireme

37、nts 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. Certain requirements relating to medical devices for biological testing, selection of tests, and the allocation of devi

38、ces 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 residuals was referred to ISO/TC 194. Other International Standards delineate particular requirements for biological testing f

39、or 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 to ensure that the levels of residual EO, ethylene chlorohydrin (ECH) and ethylene glycol (EG) pose a minimal risk to

40、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. EO is known to exhibit a number of biological effects. In the development of this part of ISO 10993, consideration was

41、given to these effects, which include irritation, organ damage, mutagenicity and carcinogenicity in humans and animals, and reproductive effects in animals. Similar consideration was given to the harmful effects of ECH and EG. In practice, for most devices, exposure to EO and ECH is considerably low

42、er 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, exposure to EO residues should be minimized. Requirements herein are in addition to the biological evaluation and te

43、sting 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 re

44、sidues for ethylene chlorohydrin (ECH), when ECH has been found to be present in medical devices sterilized with EO, are also specified. Local effects (e.g., irritation) have been considered and are incorporated in the tolerable contact limit (TCL) as given in 4.3.5.2 and Annex G for EO, and in 4.3.

45、5.3 and Annex H for ECH. 4DIN EN ISO 10993-7:2009-02 EN ISO 10993-7:2008 (E)1 Scope This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and method

46、s for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in the informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not c

47、overed by this part of ISO 10993. NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG). 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 referenc

48、es, the latest edition of the referenced document (including any amendments) applies. ISO 10993-1:1), Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993-3, Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcino

49、genicity and reproductive toxicity ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity ISO 10993-12, Biological evaluation of medical devices Part 12: Sample preparation and reference materials ISO 10993-17:2002, Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 10993-1, IS