EN ISO 11979-7-2018 Ophthalmic implants - Intraocular lenses - Part 7 Clinical investigations of intraocular lenses for the correction of aphakia.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Ophthalmic implants - Intraocular lensesPart 7: Clinical investigations of intraocular lenses for the correction of aphakiaBS EN ISO 11979-7:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-7 May 2018

2、ICS 11.040.70 Supersedes EN ISO 11979-7:2014, EN ISO 11979-9:2006English Version Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018) Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigatio

3、ns cliniques de lentilles intraoculaires pour la correction de laphakie (ISO 11979-7:2018) Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prfungen von Intraokularlinsen fr die Korrektion von Aphakie (ISO 11979-7:2018) This European Standard was approved by CEN on 28 February 2018.

4、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. Up-to-date lists and bibliographical references concerning such national standards may be obtained on a

5、pplication to the CEN-CENELEC 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 notified to the CEN-CENELEC

6、 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, Iceland, Ireland, Italy,

7、Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre:

8、 Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11979-7:2018 ENational forewordThis British Standard is the UK implementation of EN ISO 11979-7:2018, incorporating correction notice 3

9、0 May 2018. It is identical to ISO 11979-7:2018. It supersedes BS EN ISO 11979-9:2006+A1:2014 and BS EN ISO 11979-7:2014, which are withdrawn.CEN correction notice 30 May 2018 updated the supersession details in the European front matter.The UK participation in its preparation was entrusted to Techn

10、ical Committee CH/172/7, Eye implants.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 contract. Users are responsible for its correct application. The British Standards In

11、stitution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 93046 1ICS 11.040.70Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2018.Amendments

12、/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 11979-7:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-7 May 2018 ICS 11.040.70 Supersedes EN ISO 11979-7:2014, EN ISO 11979-9:2006English Version Ophthalmic implants - Intraocular lenses - Part 7: Cl

13、inical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018) Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques de lentilles intraoculaires pour la correction de laphakie (ISO 11979-7:2018) Ophthalmische Implantate - Intraokularlinse

14、n - Teil 7: Klinische Prfungen von Intraokularlinsen fr die Korrektion von Aphakie (ISO 11979-7:2018) This European Standard was approved by CEN on 28 February 2018. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Stan

15、dard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (Englis

16、h, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bu

17、lgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switz

18、erland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN nat

19、ional Members. Ref. No. EN ISO 11979-7:2018 EBS EN ISO 11979-7:2018EN ISO 11979-7:2018 (E) 3 European foreword This document (EN ISO 11979-7:2018) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics“ in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the s

20、ecretariat 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, at the latest by November 2018, and conflicting national standards shall be withdrawn at the latest by November 2018. Attention i

21、s drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11979-7:2014 and EN ISO 11979-9:2006. According to the CEN-CENELEC Internal Regu

22、lations, 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, Ireland, I

23、taly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11979-7:2018 has been approved by CEN as EN ISO 11979-7:2018 without any modification.

24、 BS EN ISO 11979-7:2018ISO 11979-7:2018(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms, definitions and abbreviated terms 13.1 Terms and definitions . 13.2 Abbreviated terms . 14 Justification for a clinical investigation 25 Ethical considerations 26 General requirements . 26.

25、1 General . 26.2 Design of a clinical investigation . 26.2.1 Requirements for all types of IOLs . 26.2.2 Additional requirements for toric IOLs (TIOLs) . 36.2.3 Additional requirements for multifocal IOLs (MIOLs) 36.2.4 Additional requirements for accommodating IOLs (AIOLs) 36.2.5 Additional require

26、ments for anterior chamber IOLs . 36.3 Characteristics of clinical investigations 46.3.1 General 46.3.2 Characteristics to be studied for all types of IOLs . 46.3.3 Additional characteristics to be studied for TIOLs . 46.3.4 Additional characteristics to be studied for MIOLs . 56.3.5 Additional char

27、acteristics to be studied for AIOLs . 56.3.6 Additional characteristics applying to anterior chamber IOLs 56.3.7 Additional characteristics 56.4 Duration of the investigations . 56.5 Enrolment 66.6 Bilateral implantation . 66.7 Surgical technique 66.8 Examination and treatment of subjects. 66.9 Adve

28、rse events reports 76.10 Inclusion and exclusion criteria . 76.10.1 General 76.10.2 Additional inclusion criteria for TIOLs . 76.10.3 Additional exclusion criteria for MIOLs . 76.10.4 Additional exclusion criteria for anterior chamber IOLs 8Annex A (informative) General elements in the clinical inve

29、stigation of IOLs . 9Annex B (informative) Additional elements for the clinical investigation of TIOLs.14Annex C (informative) Additional elements for the clinical investigation of multifocal IOLs 19Annex D (informative) Additional elements in the clinical investigation of accommodating IOLs 22Annex

30、 E (informative) Evaluation of post-operative adverse events and visual acuity rates.27Annex F (informative) Clinical tests .31Annex G (informative) Statistical methods and sample size calculations 37Bibliography .42 ISO 2018 All rights reserved iiiContents PageBS EN ISO 11979-7:2018ISO 11979-7:2018

31、(E)ForewordISO (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 a

32、 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 matte

33、rs of electrotechnical standardization. The procedures used to develop this document 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 doc

34、ument was drafted in accordance with the editorial rules of the ISO/IEC Directives, 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 al

35、l such patent rights. Details of any patent rights identified during the development 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

36、and does not constitute an endorsement. For an explanation on the voluntary nature of standards, 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

37、to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This fourth edition cancels and replaces the third edition (ISO 11979-7:2014). It also can

38、cels and replaces the first edition of ISO 11979-9:2006 and its amendment ISO 11979-9:2006/Amd 1:2014.The main changes compared to the previous edition are as follows: Integration of the multifocal intraocular lens document (ISO 11979-9:2006); Technical updates concerning the safety and efficacy of

39、the intraocular lens subtypes monofocal, multifocal, toric and accommodating; Recommendations for the clinical investigations of novel lens models; and The separation of guidance for intraocular lenses used in cases of aphakia, and intraocular lens used for the correction of ametropia in phakic pati

40、ents.A list of all parts in the ISO 11979 series can be found on the ISO website.iv ISO 2018 All rights reservedBS EN ISO 11979-7:2018ISO 11979-7:2018(E)IntroductionIntraocular lenses (IOLs) are used to correct residual refractive errors in subjects who have aphakia. Such residual refractive errors

41、typically include sphere and astigmatism, but can also include accommodation. Different designs of IOLs can be used to correct for specific refractive errors. In the case where an IOL is designed to provide more than one type of refractive correction, that IOL will have to satisfy each of the separa

42、te requirements of those correction designs.This document provides requirements and recommendations for intraocular lens investigations of new IOL models. In the case where an IOL model is a modification of a parent IOL model, a risk analysis can be used in order to determine the appropriate level o

43、f testing. ISO 2018 All rights reserved vBS EN ISO 11979-7:2018Ophthalmic implants Intraocular lenses Part 7: Clinical investigations of intraocular lenses for the correction of aphakia1 ScopeThis document specifies the particular requirements for the clinical investigations of intraocular lenses th

44、at are implanted in the eye in order to correct aphakia.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 document. For dated references, only the edition cited applies. For undated references, t

45、he latest edition of the referenced document (including any amendments) applies.ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: VocabularyISO 11979-10:2018, Ophthalmic implants Intraocular lenses Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic

46、 eyesISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceISO 14971, Medical devices Application of risk management to medical devices3 Terms, definitions and abbreviated terms3.1 Terms and definitionsFor the purposes of this document the terms and definition

47、s given in ISO 11979-1 and ISO 14155 apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online browsing platform: available at h t t p s :/ www .iso .org/ obp3.2 Abbreviated

48、termsUDVA uncorrected distance visual acuityUIVA uncorrected intermediate visual acuityUNVA uncorrected near visual acuityCDVA corrected distance visual acuityCIVA corrected intermediate visual acuityINTERNATIONAL STANDARD ISO 11979-7:2018(E) ISO 2018 All rights reserved 1BS EN ISO 11979-7:2018ISO 1

49、1979-7:2018(E)CNVA corrected near visual acuityDCIVA distance corrected intermediate visual acuityDCNVA distance corrected near visual acuity4 Justification for a clinical investigationA risk analysis shall be implemented in accordance with ISO 14971. If the risk analysis identifies the need for a clinical investigation, the requirements of ISO 14155 shall apply, with additional requirements given in this document.If a new IOL model is a modification of a parent IOL for which the safety and performance have already been established