BS EN ISO 11979-8-2017 Ophthalmic implants Intraocular lenses Fundamental requirements《眼内植入物 隐形眼镜 基本要求》.pdf

1、Ophthalmic implants Intraocular lensesPart 8: Fundamental requirementsBS EN ISO 119798:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 119798:2017. It supersedes BS EN ISO 119798:2015, whic

2、h is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/172, Ophthalmic optics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contr

3、act. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 93244 1ICS 11.040.70Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the aut

4、hority of the Standards Policy and Strategy Committee on 30 June 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 119798:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 119798May 2017ICS 11.040.70 Supersedes EN ISO 119798:2015EUROPEAN COMMITTEE

5、 FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCENCENELEC Management Centre: Avenue Marnix 17, B1000 Brussels 2017 CEN Ref. No. EN ISO 119798:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersOphthalmic implants

6、 Intraocular lenses Part 8: Fundamental requirements (ISO 119798:2017) Implants ophtalmiques Lentilles intraoculaires Partie 8: Exigences fondamentales (ISO 119798:2017) Ophthalmische Implantate Intraokularlinsen Teil 8: Grundlegende Anforderungen (ISO 119798:2017) This European Standard was approve

7、d by CEN on 8 March 2017.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. Uptodate lists and bibliographical references concerning such national standar

8、ds may be obtained on application to the CENCENELEC 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 a CEN member into its own language and notifi

9、ed to the CEN-CENELEC Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Icela

10、nd, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 119798:2017 (E)European forewordThis document (EN ISO 119798:2017) has been prepared by Te

11、chnical Committee ISO/TC 172 “Optics and photonics” 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, either by publication of an identical text or by endorsement,

12、at the latest by November 2017, and conflicting national standards shall be withdrawn at the latest by November 2017.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

13、any or all such patent rights.This document supersedes EN ISO 119798:2015 .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 Directive(s).For relationship with EU Directive(s), se

14、e informative Annex ZA, which is an integral part of this document.The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the editi

15、on cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged stateofart.When an IEC or ISO standard is referr

16、ed to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below.NOTE The way in which these referenced documents are cited in normative requirements determ

17、ines the extent (in whole or in part) to which they apply.Table 1 Correlation between normative references and dated EN and ISO standardsNormative references as listed in Clause 2 of the ISO standardEquivalent dated standardEN ISOISO 119791 EN ISO 119791:2012 ISO 119791:2012 ISO 119792 EN ISO 119792

18、:2014 ISO 119792:2014 ISO 119793 EN ISO 119793:2012 ISO 119793:2012 ISO 119794 EN ISO 119794:2008 + A1:2012 ISO 119794:2008 + Amd.1:2012ISO 119795 EN ISO 119795:2006 ISO 119795:2006 ISO 119796 EN ISO 119796:2014 ISO 119796:2014 ISO 119797 EN ISO 119797:2014 ISO 119797:2014 ISO 119799 EN ISO 119799:2

19、006 + A1:2014 ISO 119799:2006 + Amd.1:2014ISO 1197910 EN ISO 1197910:2006 + A1:2014 ISO 1197910:2006 + Amd.1:2014ISO 14155 EN ISO 14155:2011 + AC:2011 ISO 14155:2011 + Cor.1:2011ISO 14630 EN ISO 14630:2012 ISO 14630:2012 ISO 14971 EN ISO 14971:2012 ISO 14971:2007 According to the CENCENELEC Internal

20、 Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Irela

21、nd, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, iiBS EN ISO 119798:2017EN ISO 119798:2017 (E)Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 119798:2017 has been approved by CEN a

22、s EN ISO 119798:2017 without any modification.iiiBS EN ISO 119798:2017ISO 119798:2017(E)Foreword v1 Scope . 12 Normative references 13 Terms and definitions . 14 Safety and performance 25 Optical and mechanical properties . 26 Biocompatibility . 27 Clinical evaluation 28 Manufacturing . 29 Steriliza

23、tion . 29.1 General . 29.2 Bacterial endotoxins. 310 Packaging and shelflife 311 Labelling and information 312 Documentation . 3Bibliography 4iv ISO 2017 All rights reservedContents PageBS EN ISO 119798:2017ISO 119798:2017(E)ForewordISO (the International Organization for Standardization) is a world

24、wide 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 a technical committee has been established has the right to be represented on t

25、hat committee. International organizations, governmental and nongovernmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this docu

26、ment and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directiv

27、es, Part 2 (see www.iso.org/directives).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 responsible for identifying any or all such patent rights. Details of any patent rights identified during the developmen

28、t of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of s

29、tandards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was p

30、repared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This third edition cancels and replaces the second edition (ISO 119798:2006 ), which has been technically revised. It also incorporates the Amendment ISO 119798:2006/Amd 1:2011.A lis

31、t of all the parts in the ISO 11979 series can be found on the ISO website. ISO 2017 All rights reserved vBS EN ISO 119798:2017This page deliberately left blankOphthalmic implants Intraocular lenses Part 8: Fundamental requirements1 ScopeThis document specifies fundamental requirements for all types

32、 of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this

33、document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 119792 , Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methodsISO 119793 , Ophthalmic implants Int

34、raocular lenses Part 3: Mechanical properties and test methodsISO 119794 , Ophthalmic implants Intraocular lenses Part 4: Labelling and informationISO 119795 , Ophthalmic implants Intraocular lenses Part 5: BiocompatibilityISO 119796 , Ophthalmic implants Intraocular lenses Part 6: Shelf-life and tr

35、ansport stability testingISO 119797 , Ophthalmic implants Intraocular lenses Part 7: Clinical investigationsISO 119799 1), Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lensesISO 1197910 , Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lensesISO 14155 , Cl

36、inical investigation of medical devices for human subjects Good clinical practiceISO 14630 , Non-active surgical implants General requirementsISO 14971 , Medical devices Application of risk management to medical devices3 Terms and definitionsFor the purposes of this document, the terms and definitio

37、ns given in ISO 11979-1 apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 1) ISO 119797 is under revision. The revised

38、standard will incorporate multifocal intraocular lenses. When the revised standard is published, ISO 119799 will be withdrawn.INTERNATIONAL STANDARD ISO 119798:2017(E) ISO 2017 All rights reserved 1BS EN ISO 119798:2017ISO 119798:2017(E)4 Safety and performanceThe safety and performance of an intrao

39、cular lens shall be demonstrated by preclinical and clinical evaluation, including suitable risk analysis in accordance with ISO 14971 .In cases where a test method referenced in this document is not suitable for a certain design or a certain application, an alternative test method devised by the ma

40、nufacturer shall be validated, justified and documented.5 Optical and mechanical propertiesThe manufacturer shall ensure that the intraocular lens conforms to applicable requirements in ISO 119792 , ISO 119793 , ISO 119799 and ISO 1197910 . The manufacturer shall record and justify any deviations fr

41、om those standards.6 BiocompatibilityThe manufacturer shall have documented evidence that demonstrates the intraocular lens to be biocompatible by assessment in accordance with ISO 119795 .Manufacturers can take into consideration previous experience and data when determining the extent of further b

42、iocompatibility testing.7 Clinical evaluationThe first step in the clinical evaluation is a review of the available literature (published and unpublished) in order to determine if that information is sufficient to demonstrate the safety and performance of the device (see ISO 14155 ). One option is t

43、o demonstrate that the new intraocular lens model is a minor modification of a model, the safety and performance of which has previously been demonstrated.NOTE ISO/TR 22979 provides a framework for assessment whether or not a modification is minor.If the clinical evaluation identifies the need for a

44、 clinical investigation, the requirements of ISO 14155 shall apply. In addition, the following standards apply depending on the type of the intraocular lens:a) ISO 119797 for monofocal intraocular lenses for the correction of aphakia;b) ISO 119799 for multifocal intraocular lenses for the correction

45、 of aphakia;c) ISO 1197910 for phakic monofocal intraocular lenses.8 ManufacturingIntraocular lenses shall be manufactured in such a way that the specified design attributes are achieved.9 Sterilization9.1 GeneralIntraocular lenses shall be supplied sterile. Sterilization shall adhere to the general

46、 provisions laid out in ISO 14630 .For sterilization by ethylene oxide (EO), the following applies:a) for the assay of EO residues, an exhaustive solvent or head space extraction method shall be chosen;b) the residue of EO in intraocular lenses shall not exceed 0,5 g EO per lens per day, or 1,25 g p

47、er lens;2 ISO 2017 All rights reservedBS EN ISO 119798:2017ISO 119798:2017(E)c) the residue of ethylene chlorohydrin shall not exceed a release of more than 2,0 g per lens per day and not exceed 5,0 g in total per lens.For solvent extraction, a solvent affording exhaustive extraction shall be chosen

48、, e.g. one that adequately swells the lens material without disrupting the material itself. For headspace extraction, efficiency of extraction shall be demonstrated by validation against an exhaustive solvent extraction method. In case the extraction is not exhaustive, release criteria shall be lowe

49、red in proportion to the relative efficiency of the method.NOTE The level of ethylene glycol is correlated to the levels of ethylene oxide and ethylene chlorhydrin present. If the levels of ethylene oxide and ethylene chlorhydrin are within the limits set in b) and c), the level of ethylene glycol will be sufficiently low that there is no need to quantify it.9.2 Bacterial endotoxinsThe level of biological contaminati