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 眼内透镜设计改进的临床研究需要的评.pdf

1、Ophthalmic implants Intraocular lenses Guidance on assessment of the need for clinical investigation of intraocular lens design modifications PD ISO/TR 22979:2017 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06 ISO 2017 Ophthalmic implants Intraocular lenses Guidan

2、ce on assessment of the need for clinical investigation of intraocular lens design modifications Implants ophtalmiques Lentilles intraoculaires Directives relatives lvaluation de la ncessit dinvestigation clinique pour les modifications de conception des lentilles intraoculaires TECHNICAL REPORT ISO

3、/TR 22979 Reference number ISO/TR 22979:2017(E) Second edition 2017-05 National foreword This 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 It supersedes PD ISO/TR 22979:2006 which is withdrawn.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

4、, 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 Institution 2017Publish

5、ed by BSI Standards Limited 2017 ISBN 978 0 580 85343 2 ICS 11.040.70 Compliance 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

6、issued since publication Date Textaffected PUBLISHED DOCUMENT PD ISO/TR 22979:2017 ISO 2017 Ophthalmic implants Intraocular lenses Guidance on assessment of the need for clinical investigation of intraocular lens design modifications Implants ophtalmiques Lentilles intraoculaires Directives relative

7、s lvaluation de la ncessit dinvestigation clinique pour les modifications de conception des lentilles intraoculaires TECHNICAL REPORT ISO/TR 22979 Reference number ISO/TR 22979:2017(E) Second edition 2017-05 PD ISO/TR 22979:2017 ISO/TR 22979:2017(E)ii ISO 2017 All rights reserved COPYRIGHT PROTECTED

8、 DOCUMENT ISO 2017, Published in Switzerland All 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 wr

9、itten permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org PD ISO/

10、TR 22979:2017 ISO/TR 22979:2017(E)ii ISO 2017 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in Switzerland All 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

11、, including photocopying, or posting on the internet 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 office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switze

12、rland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.orgISO/TR 22979:2017(E)Foreword iv 1 Scope . 1 2 Normative references 1 3 Terms and definitions . 1 4 Modifications to parent models 1 4.1 General . 1 4.2 Modification levels . 2 4.2.1 General 2 4.2.2 Level A modifications . 2

13、 4.2.3 Level B modifications . 2 4.2.4 Level C modifications . 2 4.2.5 Clinical investigation with multiple IOL models. 3 5 Considerations for the assignment of modification level 3 5.1 General . 3 5.2 Risk assessment . 3 5.3 Special considerations 3 5.3.1 Phakic lenses . 3 5.3.2 Anterior chamber le

14、nses . 3 5.3.3 Posterior chamber lenses intended for implantation in the sulcus . 4 6 Modifications of optical design features 4 6.1 Optical design changes . 4 6.2 Multifocal lenses (MIOL) 4 6.3 Toric lenses (TIOL) 4 6.4 Accommodating lenses (AIOL) 4 7 Modifications to the mechanical design . 5 7.1

15、General . 5 7.2 Mechanical analysis 5 8 Modifications to material 5 8.1 Interchanging IOL materials 5 8.2 New materials 5 Annex A (informative) Examples of modifications to a parent IOL model 6 Annex B (informative) Mechanical data analysis11 Bibliography .22 ISO 2017 All rights reserved iii Content

16、s Page PD ISO/TR 22979:2017 ISO/TR 22979:2017(E) 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

17、member body interested 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

18、 Electrotechnical 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 t

19、ypes of ISO documents 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 n

20、ot be held responsible 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 i

21、s information given 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 Organiz

22、ation (WTO) principles 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 ed

23、ition (ISO/TR 22979:2006), which has been technically revised.iv ISO 2017 All rights reserved PD ISO/TR 22979:2017 ISO/TR 22979:2017(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing

24、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 that committee. International organizations, governmental and non-governmental, in liaiso

25、n 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 document and those intended for its further maintenance are described in the ISO/IEC Direc

26、tives, 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 Directives, Part 2 (see www .iso .org/ directives). Attention is drawn to the possibility that

27、 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 development of the document will be in the Introduction and/or on the ISO list of patent dec

28、larations 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 standards, the meaning of ISO specific terms and expressions related to confor

29、mity 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 prepared by Technical Committee ISO/TC 172, Optics and photonics, SC 7 O

30、phthalmic 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 reserved TECHNICAL REPORT ISO/TR 22979:2017(E) Ophthalmic implants Intraocular lenses Guidance on assessment of the need for cli

31、nical investigation of intraocular lens design modifications 1 Scope This document provides guidance on the application 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 modificatio

32、ns to anterior and posterior chamber IOLs in accordance with ISO 14971. 11It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design. 2 Normative references The following documents are referred to in the text in suc

33、h 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, the latest edition of the referenced document (including any amendments) applies. ISO 11979-1, Ophthalmic implants Intraocular lenses Par

34、t 1: Vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11979-1 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 .elect

35、ropedia .org/ ISO Online browsing platform: available at h t t p :/ www .iso .org/ obp NOTE The terms listed are related to Annex B. 3.1 open-loop IOL IOL model which contains two loops, each loop having one end attached to the body of the IOL and the other end free 3.2 closed-loop IOL IOL model, wh

36、ich contains two loops, each loop having both ends attached to the body of the optic 3.3 hybrid open-loop/closed-loop IOL IOL model 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

37、of the IOL 4 Modifications to parent models 4.1 General IOLs, that are modifications of a parent IOL, have different requirements for clinical investigations depending on the risk associated with the modifications and depending on their location in the eye. ISO 2017 All rights reserved 1 PD ISO/TR 2

38、2979:2017 ISO/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 13485 10provides requirements for the design and development of medical devices,

39、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 sourc

40、es for data and information for estimating risks. To determine and evaluate the hazards associated with the modification of IOL models, the manufacturer can additionally use the following sources: a) clinical data; b) literature study of equivalent features of similar IOL models. The literature can

41、be general published and unpublished reports, proprietary evaluations and post-market surveillance reports; c) physical model-eyes, laboratory bench testing or numerical/computational models, which have been verified and validated for evaluation of optical and mechanical behaviour; d) usability and

42、human factor engineering data resulting from the application of IEC 62366-1 12or ANSI/AAMI HE75 13such as the use of error risk analysis, formative and summative evaluation results, including studies to evaluate surgical manipulation and delivery of the IOL in the eye. Modifications to the delivery

43、system are subject to the design control process in accordance with ISO 13485 and factors that pertain to the interaction of IOL and delivery system, as described in ISO 11979-3, and user interaction during surgery are to be considered in a risk assessment. 4.2 Modification levels 4.2.1 General Desi

44、gn modifications to parent model IOLs are classified as Level A, B or C. The classification depends on the safety and performance risks that are identified. Examples of risks associated with design modifications are provided in Annex A. 4.2.2 Level A modifications Level A modifications of a parent m

45、odel are those for which all safety and performance questions can be adequately addressed without clinical investigation. The modified model is essentially equivalent to the parent model(s). All risks resulting from risk assessment to the modification are adequately addressed by existing clinical ev

46、idence. The residual risk will have to be outweighed by the benefits. 4.2.3 Level B modifications Level B modifications of a parent model are those that raise safety and/or performance risks that can be adequately addressed with a limited clinical investigation of a justified number of subjects foll

47、owed 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 to detect differences from the safety and performance end points (SPE) ratings is provided in ISO 11979-7. 4.2.4 Level C modifications Level C mo

48、difications are modifications that raise safety and/or performance risks that can only be addressed with a full clinical investigation as defined in ISO 11979-7 and ISO 11979-10.2 ISO 2017 All rights reserved PD ISO/TR 22979:2017 ISO/TR 22979:2017(E) This document provides considerations for the ris

49、k assessment to determine the clinical investigation effort that is needed based on the level of modification which is defined in 4.2. ISO 13485 10provides 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 of the risk management in the design control process in accordance with ISO 14971, and can be used as input for the clinical evaluation