DIN EN ISO 11979-5-2010 Ophthalmic implants - Intraocular lenses - Part 5 Biocompatibility (ISO 11979-5 2006) German version EN ISO 11979-5 2006《眼科植入物 眼内透镜 第5部分 生物适应性(ISO 11979-5-2.pdf

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1、November 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).I

2、CS 11.040.70!$lf“1730467www.din.deDDIN EN ISO 11979-5Ophthalmic implants Intraocular lenses Part 5: Biocompatibility (ISO 11979-5:2006)English translation of DIN EN ISO 11979-5:2010-11Ophthalmische Implantate Intraokularlinsen Teil 5: Biokompatibilitt (ISO 11979-5:2006)Englische bersetzung von DIN E

3、N ISO 11979-5:2010-11Implants ophtalmiques Lentilles intraoculaires Partie 5: Biocompatibilit (ISO 11979-5:2006)Traduction anglaise de DIN EN ISO 11979-5:2010-11SupersedesDIN EN ISO 11979-5:2006-09www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered

4、authoritative.3211.10 DIN EN ISO 11979-5:2010-11 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” in collaboration with Technical Committee CEN/TC

5、 170 “Ophthalmic optics” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee). The DIN Standards corresponding to the International Standards referred to in Clause 2 of

6、 this document are as follows: ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-2 DIN EN ISO 10993-2 ISO 10993-3 DIN EN ISO 10993-3 ISO 10993-6 DIN EN 30993-6 ISO 10993-10 DIN EN ISO 10993-10 ISO 10993-12 DIN EN ISO 10993-12 ISO 11979-1 DIN EN ISO 11979-1 ISO 11979-2 DIN EN ISO 11979-2 ISO 11979-3 DIN EN IS

7、O 11979-3 ISO 14971 DIN EN ISO 14971 For further standards relating to intraocular lenses see National Annex NA. Amendments This standard differs from DIN EN 13503-5:2001-07 as follows: a) the test for leachable substances has been given in more detail; it has been subdivided into the exhaustive ext

8、raction test, the test for leachables and the test for hydrolytic stability; b) biological tests have been included; c) the test procedures given in the Annexes have been rendered more precise, in particular the treatment of test and control material; d) general information on the individual procedu

9、res has been transferred from the Annexes to the corresponding clauses of the standard; e) further cross-references to existing standards have been included to eliminate redundant texts; f) as to risk assessment, reference is now made to DIN EN ISO 14971 (formerly DIN EN 1441); g) the former Annex E

10、 “Selected definitions” has been deleted. Instead, reference is made to DIN EN ISO 11979-1; h) the revised standard has been adopted as EN ISO Standard. DIN EN ISO 11979-5:2010-11 3 As compared with DIN EN ISO 11979-5:2006-09, the following corrections have been made to the German version only and t

11、herefore do not affect the English text: a) in Subclause 5.5.a), the term “Wendekreis des Krebses” has been replaced by “nrdlichen Wendekreis”; b) in Subclause 6.1, paragraph 3, “in vivo” has been added; c) in Subclauses A.3, C.6.2 and C.6.3, some modal auxiliaries have been corrected; d) in Subclau

12、se A.6.7, the term “Massenspektrographie” has been changed to “Massenspektroskopie”; e) in Subclause A.7, the word “getrockneten” has been added and the term “Dunstabzug” has been replaced by “Abzug”; f) Subclause B.6.1, paragraph 1, has been reformulated and the wording “ist das Prfmaterial bei 37

13、C 2 C ber 7 h 1 h zu extrahieren” has been deleted; g) in Subclause D.7, the term “Hinterkammerlinse” has been corrected to read “Vorderkammerlinse”; h) in Subclause F.1.5, “energiedispersiven Rntgenspektrometers (EDX)” has been added; i) some editorial amendments have been made in Clause 4 and Subc

14、lauses 5.1.2, 5.4, 5.2 and C.7. Previous editions DIN EN 13503-5: 2001-07 DIN EN ISO 11979-5: 2006-09 National Annex NA (informative) Bibliography DIN EN 30993-6, Biological evaluation of medical devices Part 6: Tests for local effects after implantation DIN EN ISO 10993-1, Biological evaluation of

15、medical devices Part 1: Evaluation and testing 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, carcinogenicity and reproductive toxicity DIN EN ISO 10993-10 B

16、iological 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 11979-1, Ophthalmic implants Intraocular lenses Part 1: Vocabulary DIN

17、EN ISO 11979-2, Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methods 2DIN EN ISO 11979-5:2010-11 4 DIN EN ISO 11979-3, Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methods DIN EN ISO 11979-4, Ophthalmic implants Intraocular lenses Part 4

18、: Labelling and information DIN EN ISO 11979-6, Ophthalmic implants Intraocular lenses Part 6: Shelf-life and transport stability DIN EN ISO 11979-7, Ophthalmic implants Intraocular lenses Part 7: Clinical investigations DIN EN ISO 11979-8, Ophthalmic implants Intraocular lenses Part 8: Fundamental

19、requirements DIN EN ISO 11979-9, Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses DIN EN ISO 11979-10, Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses DIN EN ISO 14971, Medical devices Application of risk management to medical devices EUROPEAN ST

20、ANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11979-5June 2006ICS 11.040.70 Supersedes EN 13503-5:2001 English VersionOphthalmic implants - Intraocular lenses - Part 5:Biocompatibility (ISO 11979-5:2006)Implants ophtalmiques - Lentilles intraoculaires - Partie 5:Biocompatibilit (ISO 11979-5:2006)Ophtha

21、lmische Implantate - Intraokularlinsen - Teil 5:Biokompatibilitt (ISO 11979-5:2006)This European Standard was approved by CEN on 13 April 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a nat

22、ional standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any

23、 other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland,

24、France,Germany, Greece, Hungary, 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

25、NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11979-5:2006: EContents Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions

26、.5 4 General requirements applying to biocompatibility evaluation of intraocular lenses6 5 Physicochemical tests 6 6 Biological tests 9 Annex A (normative) Exhaustive extraction test .11 Annex B (normative) Test for leachables .14 Annex C (normative) Hydrolytic stability16 Annex D (normative) Photos

27、tability test.19 Annex E (normative) Nd-YAG laser exposure test 21 Annex F (informative) Supplemental conditions of test for local effects after implantation.23 Annex G (normative) Ocular implantation test 24 Bibliography 28 EN ISO 11979-5:2006 (E) DIN EN ISO 11979-5:2010-11 2 Foreword This document

28、 (EN ISO 11979-5:2006) has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, eith

29、er by publication of an identical text or by endorsement, at the latest by December 2006, and conflicting national standards shall be withdrawn at the latest by December 2006. This document supersedes EN 13503-5:2001. According to the CEN/CENELEC Internal Regulations, the national standards organiza

30、tions of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovak

31、ia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 11979-5:2006 has been approved by CEN as EN ISO 11979-5:2006 without any modifications. EN ISO 11979-5:2006 (E) DIN EN ISO 11979-5:2010-11 3 Introduction This part of ISO 11979 follows the general princip

32、les given in ISO 10993-1. ISO 10993-1 describes the principles governing the biological evaluation of medical devices, the definitions of categories based on the nature and duration of contact with the body, and selection of appropriate tests. Other parts of ISO 10993 present biological test methods

33、, tests for ethylene oxide residues, tests for degradation and principles for sample preparation. EN ISO 11979-5:2006 (E) DIN EN ISO 11979-5:2010-11 4 1 Scope This part of ISO 11979 specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) inclu

34、ding the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test. 2 Normative references The following referenced documents are indispensable for

35、 the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing ISO 10993-2, Biologi

36、cal evaluation of medical devices Part 2: Animal welfare requirements ISO 10993-3, Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-6, Biological evaluation of medical devices Part 6: Tests for local effects after implantati

37、on 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 11979-1, Ophthalmic implants Intraocular lenses Part 1: Vocabulary

38、ISO 11979-2, Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methods ISO 11979-3, Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methods ISO 14971, Medical devices Application of risk management to medical devices 3 Terms and definitions For

39、the purposes of this document, the terms and definitions given in ISO 11979-1 apply. EN ISO 11979-5:2006 (E) DIN EN ISO 11979-5:2010-11 5 4 General requirements applying to biocompatibility evaluation of intraocular lenses The evaluation of the biocompatibility of the test material shall start with

40、an initial assessment of risk in accordance with ISO 14971. The physicochemical tests described in Clause 5 shall first be considered. The evaluation of the material for biological safety shall then be undertaken in accordance with the principles and requirements of ISO 10993-1 and ISO 10993-2, taki

41、ng into consideration the results from the physicochemical tests. Furthermore, the risk assessment shall include an assessment of the potential for material changes such as calcification. This risk assessment should consider the history of clinical use of the material, and animal models to test the

42、long-term stability of the material. Carry out the biocompatibility testing in accordance with ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6 and ISO 10993-10 and as noted in this part of ISO 11979. The pre-existing information on the material and all the information obtained in the evaluation p

43、rocess shall be integrated in an overall risk benefit assessment in accordance with ISO 14971. 5 Physicochemical tests 5.1 General 5.1.1 The following physicochemical tests shall be considered: a) exhaustive extraction; b) leachables; c) hydrolytic stability; d) photostability against ultraviolet/vi

44、sible (UV/Vis) irradiation; e) stability against Nd-YAG laser exposure; f) insoluble inorganics. 5.1.2 The objectives of this group of tests are: a) to quantify possible residues from synthesis and additives or impurities from manufacturing and packaging; b) to quantify possible degradation products

45、 due to hydrolysis; c) to quantify leachable chemical components; and d) to facilitate an analysis of any risks introduced by toxic products which may result from processing, treatment in use, or ageing of the test material. 5.1.3 The results of the tests given in 5.1.1 and 5.1.2 shall be recorded a

46、nd included in the assessment for risk in accordance with ISO 14971. If any of the above tests was not performed, a rationale justifying this decision shall be documented. EN ISO 11979-5:2006 (E) DIN EN ISO 11979-5:2010-11 6 5.2 Exhaustive extraction test The test material shall be tested for extrac

47、tables under exhaustive extraction conditions in accordance with the method described in Annex A, which describes several extraction conditions, including the extraction media, temperature and duration. Alternate methods can be used provided that they have been validated. The following shall be obse

48、rved. a) The reasons for selecting each solvent shall be justified and documented. b) The extraction media shall be qualitatively and quantitatively analysed at the end of extraction for possible extractable components of the material, such as process contaminants, residual monomers, additives, and

49、other extractable components. The detection limit for the extractables shall be established based on a risk assessment of the total exposure to the patient and it shall be expressed as g/g of material. c) The test material shall be weighed before and after extraction and any change in mass shall be calculated. The results shall be evaluated to assess the risk for potentially harmful effects due to extractable components and they shall be recorded. 5.3 Test for leachables The test m