BS EN ISO 11979-5-2006 Ophthalmic implants - Intraocular lenses - Biocompatibility《眼科植入物 眼内透镜 生物相容性》.pdf

1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58The European Standard EN ISO 11979-5:2006 has the status of a British StandardICS 11.040.70Ophthalm

2、ic implants Intraocular lenses Part 5: BiocompatibilityBRITISH STANDARDBS EN ISO 11979-5:2006BS EN ISO 11979-5:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2006 BSI 2006ISBN 0 580 48582 XCross-referencesThe British Standards wh

3、ich implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publica

4、tion does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations.Summary of pagesThis document comprises a front cover, an inside front cover, t

5、he EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 24, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date Comme

6、ntsA list of organizations represented on this subcommittee can be obtained on request to its secretary. present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and Europea

7、n developments and promulgate them in the UK.National forewordThis British Standard is the official English language version of EN ISO 11979-5:2006. It is identical with ISO 11979-5:2006. It supersedes BS EN 13503-5:2001 which is withdrawn.The UK participation in its preparation was entrusted by Tec

8、hnical Committee CH/172, Ophthalmic optics, to Subcommittee CH/172/7, Eye implants, which has the responsibility to: aid enquirers to understand the text;EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11979-5June 2006ICS 11.040.70 Supersedes EN 13503-5:2001 English VersionOphthalmic implants

9、- Intraocular lenses - Part 5:Biocompatibility (ISO 11979-5:2006)Implants ophtalmiques - Lentilles intraoculaires - Partie 5:Biocompatibilit (ISO 11979-5:2006)Ophthalmische Implantate - Intraokularlinsen - Teil 5:Biokompatibilitt (ISO 11979-5:2006)This European Standard was approved by CEN on 13 Apr

10、il 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 national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtaine

11、d 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 other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretari

12、at has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

13、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 2006 CEN All rights of exploitation in any form and by any means reserved

14、worldwide for CEN national Members.Ref. No. EN ISO 11979-5:2006: EForeword This document supersedes EN 13503-5:2001. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Cypr

15、us, Czech Republic, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice text or by endorsement, at the latest by December 2006, and conflicting national standards shall be withdrawnThis document (EN

16、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. at the latest by December 2006. This European Standard shall be given the status o

17、f a national standard, either by publication of an identicalDenmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, The text of ISO 11979-5:2006 has been approved by CEN as EN ISO 11979-5:2006 without any modifications.EN ISO 11979-5:2006Reference num

18、berISO 11979-5:2006(E)INTERNATIONAL STANDARD ISO11979-5Second edition2006-06-01Ophthalmic implants Intraocular lenses Part 5: Biocompatibility Implants ophtalmiques Lentilles intraoculaires Partie 5: Biocompatibilit EN ISO 11979-5:2006ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Norm

19、ative references . 1 3 Terms and definitions. 1 4 General requirements applying to biocompatibility evaluation of intraocular lenses. 2 5 Physicochemical tests . 2 6 Biological tests . 5 Annex A (normative) Exhaustive extraction test 7 Annex B (normative) Test for leachables 10 Annex C (normative) H

20、ydrolytic stability. 12 Annex D (normative) Photostability test 15 Annex E (normative) Nd-YAG laser exposure test . 17 Annex F (informative) Supplemental conditions of test for local effects after implantation 19 Annex G (normative) Ocular implantation test . 20 Bibliography . 24 EN ISO 11979-5:2006

21、iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which

22、a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matt

23、ers of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circul

24、ated 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 to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsib

25、le for identifying any or all such patent rights. ISO 11979-5 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 11979-5:1999), which has been technically revised.

26、 ISO 11979 consists of the following parts, under the general title Ophthalmic implants Intraocular lenses: Part 1: Vocabulary Part 2: Optical properties and test methods Part 3: Mechanical properties and test methods Part 4: Labelling and information Part 5: Biocompatibility Part 6: Shelf-life and

27、transport stability Part 7: Clinical investigations Part 8: Fundamental requirements Part 9: Multifocal intraocular lenses Part 10: Phakic intraocular lenses EN ISO 11979-5:2006vIntroduction This part of ISO 11979 follows the general principles given in ISO 10993-1. ISO 10993-1 describes the princip

28、les 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, tests for ethylene oxide residues, tests for degradation

29、and principles for sample preparation. EN ISO 11979-5:2006blank1Ophthalmic implants Intraocular lenses Part 5: Biocompatibility 1 Scope This part of ISO 11979 specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing con

30、ditions 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 the application of thi

31、s 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, Biological evaluation of medic

32、al 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 implantation ISO 10993-10, Biolog

33、ical 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 ISO 11979-2, Ophthalmic

34、 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 the purposes of this do

35、cument, the terms and definitions given in ISO 11979-1 apply. EN ISO 11979-5:20062 4 General requirements applying to biocompatibility evaluation of intraocular lenses The evaluation of the biocompatibility of the test material shall start with an initial assessment of risk in accordance with ISO 14

36、971. 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, taking into consideration the results from the physicochemi

37、cal 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 long-term stability of the material. Carry out the bioc

38、ompatibility 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 process shall be integrated in an overall risk benefit a

39、ssessment 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/visible (UV/Vis) irradiation; e) stability against Nd-YAG

40、 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 due to hydrolysis; c) to quantify leachable chemical c

41、omponents; 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 and included in the assessment for risk in accordance wi

42、th ISO 14971. If any of the above tests was not performed, a rationale justifying this decision shall be documented. EN ISO 11979-5:200635.2 Exhaustive extraction test The test material shall be tested for extractables under exhaustive extraction conditions in accordance with the method described in

43、 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 observed. a) The reasons for selecting each solvent shall be justified and documented. b) Th

44、e 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 other extractable components. The detection limit for the extractables shall be establis

45、hed 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 ef

46、fects due to extractable components and they shall be recorded. 5.3 Test for leachables The test material shall be tested for leachables under simulated physiological conditions in accordance with the method described in Annex B, which specifies several extraction conditions including the extraction

47、 media, temperature and duration. The following shall be observed. 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, suc

48、h as process contaminants, residual monomers, additives, and 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. The results shall be evaluated to ass

49、ess the risk for potentially harmful effects from extractable components and they shall be recorded. 5.4 Test for hydrolytic stability Hydrolytic stability testing shall be conducted in accordance with the method described in Annex C. The following shall be observed. a) The study shall be designed to evaluate the stability of the material in an aqueous environment at 35 C 2 C for a period of at least five years or at an elevated temperature for a simulated exposure tim