ISO/TR 22979:2017
(Main)Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.
Implants ophtalmiques — Lentilles intraoculaires — Directives relatives à l'évaluation de la nécessité d'investigation clinique pour les modifications de conception des lentilles intraoculaires
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TECHNICAL ISO/TR
REPORT 22979
Second edition
2017-05
Ophthalmic implants — Intraocular
lenses — Guidance on assessment of
the need for clinical investigation of
intraocular lens design modifications
Implants ophtalmiques — Lentilles intraoculaires — Directives
relatives à l’évaluation de la nécessité d’investigation clinique pour les
modifications de conception des lentilles intraoculaires
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved
Contents Page
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
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 lenses . 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 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 analysis.11
Bibliography .22
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 a technical
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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 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 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
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URL: w w w . i s o .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 22979:2006), 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 clinical 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
[1–9]
Standards for intraocular lenses (IOLs). It addresses factors to be considered in the risk management
[11]
process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971. It
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 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, the latest edition of the referenced document (including any amendments) applies.
ISO 11979-1, Ophthalmic implants — Intraocular lenses — Part 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 http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// 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, which 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 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.
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.
[10]
ISO 13485 provides 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. 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 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 bench testing or numerical/computational models, which have
been verified and validated for evaluation of optical and mechanical behaviour;
[12]
d) usability and human factor engineering data resulting from the application of IEC 62366-1 or
[13]
ANSI/AAMI HE75 such 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 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
Design 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 model 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 evidence. 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 followed
up for a justified per
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