BS PD ISO TR 22979-2017 Ophthalmic implants Intraocular lenses Guidance on assessment of the need for clinical investigation of intraocular lens design modifications《眼科植入物 眼内透镜 眼内透.pdf

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1、Ophthalmic implants Intraocular lenses Guidance on assessment of the need for clinical investigation of intraocular lens design modificationsPD ISO/TR 22979:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06 ISO 2017Ophthalmic implants Intraocular lenses Guidance o

2、n assessment of the need for clinical investigation of intraocular lens design modificationsImplants ophtalmiques Lentilles intraoculaires Directives relatives lvaluation de la ncessit dinvestigation clinique pour les modifications de conception des lentilles intraoculairesTECHNICALREPORTISO/TR22979

3、Reference numberISO/TR 22979:2017(E)Second edition2017-05National forewordThis Published Document is the UK implementation of ISO/TR 22979:2017. It supersedes PD ISO/TR 22979:2006 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172/7, Eye implants.A

4、 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 Institution 2017Published by BSI Standard

5、s Limited 2017ISBN 978 0 580 85343 2ICS 11.040.70Compliance with a British Standard cannot confer immunity from legal obligations.This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 September 2017.Amendments/corrigenda issued since publicati

6、onDateTextaffectedPUBLISHED DOCUMENTPD ISO/TR 22979:2017 ISO 2017Ophthalmic implants Intraocular lenses Guidance on assessment of the need for clinical investigation of intraocular lens design modificationsImplants ophtalmiques Lentilles intraoculaires Directives relatives lvaluation de la ncessit d

7、investigation clinique pour les modifications de conception des lentilles intraoculairesTECHNICAL REPORTISO/TR22979Reference numberISO/TR 22979:2017(E)Second edition2017-05PD ISO/TR 22979:2017ISO/TR 22979:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in Switz

8、erlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be req

9、uested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgPD ISO/TR 22979:2017ISO/TR 22979:2017(E)ii ISO 2017 Al

10、l rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the intern

11、et or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrig

12、htiso.orgwww.iso.orgISO/TR 22979:2017(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Modifications to parent models 14.1 General . 14.2 Modification levels . 24.2.1 General 24.2.2 Level A modifications . 24.2.3 Level B modifications . 24.2.4 Level C modifications . 24.2

13、.5 Clinical investigation with multiple IOL models. 35 Considerations for the assignment of modification level 35.1 General . 35.2 Risk assessment . 35.3 Special considerations 35.3.1 Phakic lenses . 35.3.2 Anterior chamber lenses . 35.3.3 Posterior chamber lenses intended for implantation in the su

14、lcus . 46 Modifications of optical design features 46.1 Optical design changes . 46.2 Multifocal lenses (MIOL) 46.3 Toric lenses (TIOL) 46.4 Accommodating lenses (AIOL) 47 Modifications to the mechanical design . 57.1 General . 57.2 Mechanical analysis 58 Modifications to material 58.1 Interchanging

15、 IOL materials 58.2 New materials 5Annex A (informative) Examples of modifications to a parent IOL model 6Annex B (informative) Mechanical data analysis11Bibliography .22 ISO 2017 All rights reserved iiiContents PagePD ISO/TR 22979:2017ISO/TR 22979:2017(E)ForewordISO (the International Organization

16、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 technical committee has been established has t

17、he 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 matters of electrotechnical standardization.The proc

18、edures 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 document was drafted in accordance with the editori

19、al 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 all such patent rights. Details of any patent righ

20、ts 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 and does not constitute an endorsement.For an ex

21、planation 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 to Trade (TBT) see the following URL: www .iso .o

22、rg/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, SC 7 Ophthalmic optics and instruments.This second edition cancels and replaces the first edition (ISO/TR 22979:2006), which has been technically revised.iv ISO 2017 All rights reservedPD ISO/

23、TR 22979:2017ISO/TR 22979:2017(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 inter

24、ested in a subject for which 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

25、 Commission (IEC) on all matters 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 docume

26、nts should be noted. This document 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 responsi

27、ble for identifying any or all 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

28、for the convenience of users 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) principle

29、s in the Technical Barriers 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, SC 7 Ophthalmic optics and instruments.This second edition cancels and replaces the first edition (ISO/TR 22979:200

30、6), which has been technically revised.iv ISO 2017 All rights reserved TECHNICAL REPORT ISO/TR 22979:2017(E)Ophthalmic implants Intraocular lenses Guidance on assessment of the need for clinical investigation of intraocular lens design modifications1 ScopeThis document provides guidance on the appli

31、cation of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).19It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.11It also suggests methods of data analysis

32、 and interpretation that can be used to determine the need for a clinical investigation and its design.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 e

33、dition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: Vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 11979-

34、1 and the following 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 :/ www .iso .org/ obpNOTE The terms listed are related t

35、o Annex B.3.1open-loop IOLIOL model which contains two loops, each loop having one end attached to the body of the IOL and the other end free3.2closed-loop IOLIOL model, which contains two loops, each loop having both ends attached to the body of the optic3.3hybrid open-loop/closed-loop IOLIOL model

36、 which contains two loops, with one loop having one end attached to the body of the IOL and the other end free, and the other loop having both ends attached to the body of the IOL4 Modifications to parent models4.1 GeneralIOLs, that are modifications of a parent IOL, have different requirements for

37、clinical investigations depending on the risk associated with the modifications and depending on their location in the eye. ISO 2017 All rights reserved 1PD ISO/TR 22979:2017ISO/TR 22979:2017(E)This document provides considerations for the risk assessment to determine the clinical investigation effo

38、rt that is needed based on the level of modification which is defined in 4.2.ISO 1348510provides requirements for the design and development of medical devices, which are applicable to intraocular lenses including modifications of existing models. The risk assessment and design evaluation are part o

39、f the risk management in the design control process in accordance with ISO 14971, and can be used as input for the clinical evaluation. ISO 14971 describes sources for data and information for estimating risks. To determine and evaluate the hazards associated with the modification of IOL models, the

40、 manufacturer can additionally use the following sources:a) clinical data;b) literature study of equivalent features of similar IOL models. The literature can be general published and unpublished reports, proprietary evaluations and post-market surveillance reports;c) physical model-eyes, laboratory

41、 bench testing or numerical/computational models, which have been verified and validated for evaluation of optical and mechanical behaviour;d) usability and human factor engineering data resulting from the application of IEC 62366-112or ANSI/AAMI HE7513such as the use of error risk analysis, formati

42、ve and summative evaluation results, including studies to evaluate surgical manipulation and delivery of the IOL in the eye.Modifications to the delivery system are subject to the design control process in accordance with ISO 13485 and factors that pertain to the interaction of IOL and delivery syst

43、em, as described in ISO 11979-3, and user interaction during surgery are to be considered in a risk assessment.4.2 Modification levels4.2.1 GeneralDesign modifications to parent model IOLs are classified as Level A, B or C. The classification depends on the safety and performance risks that are iden

44、tified. Examples of risks associated with design modifications are provided in Annex A.4.2.2 Level A modificationsLevel A modifications of a parent model are those for which all safety and performance questions can be adequately addressed without clinical investigation. The modified model is essenti

45、ally equivalent to the parent model(s). All risks resulting from risk assessment to the modification are adequately addressed by existing clinical evidence. The residual risk will have to be outweighed by the benefits.4.2.3 Level B modificationsLevel B modifications of a parent model are those that

46、raise safety and/or performance risks that can be adequately addressed with a limited clinical investigation of a justified number of subjects followed up for a justified period.NOTE Typically 100 subjects followed up for 4 months to 6 months. The statistical precision of a 100-subject investigation

47、 to detect differences from the safety and performance end points (SPE) ratings is provided in ISO 11979-7.4.2.4 Level C modificationsLevel C modifications are modifications that raise safety and/or performance risks that can only be addressed with a full clinical investigation as defined in ISO 119

48、79-7 and ISO 11979-10.2 ISO 2017 All rights reservedPD ISO/TR 22979:2017ISO/TR 22979:2017(E)This document provides considerations for the risk assessment to determine the clinical investigation effort that is needed based on the level of modification which is defined in 4.2.ISO 1348510provides requi

49、rements for the design and development of medical devices, which are applicable to intraocular lenses including modifications of existing models. The risk assessment and design evaluation are part of the risk management in the design control process in accordance with ISO 14971, and can be used as input for the clinical evaluation. ISO 14971 describes sources for data and information for estimating risks. To determine and evaluate the hazards associated with the modification of IOL models, t