EN ISO 11979-7:2014

SLOVENSKI STANDARD
01-november-2014
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SIST EN ISO 11979-7:2006
SIST EN ISO 11979-7:2006/A1:2012
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Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-
7:2014)
Ophthalmische Implantate – Intraokularlinsen - Teil 7: Klinische Prüfungen (ISO 11979-
7:2014)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques (ISO
11979-7:2014)
Ta slovenski standard je istoveten z: EN ISO 11979-7:2014
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11979-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2014
ICS 11.040.70 Supersedes EN ISO 11979-7:2006
English Version
Ophthalmic implants - Intraocular lenses - Part 7: Clinical
investigations (ISO 11979-7:2014)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Ophthalmische Implantate - Intraokularlinsen - Teil 7:
Investigations cliniques (ISO 11979-7:2014) Klinische Prüfungen (ISO 11979-7:2014)
This European Standard was approved by CEN on 18 July 2014.

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 application 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 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, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-7:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 11979-7:2014) has been prepared by Technical 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, at the latest by March 2015, and conflicting national standards shall be withdrawn at
the latest by March 2015.
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 any or all such patent rights.
This document supersedes EN ISO 11979-7:2006.
According to the CEN-CENELEC Internal 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, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11979-7:2014 has been approved by CEN as EN ISO 11979-7:2014 without any modification.
INTERNATIONAL ISO
STANDARD 11979-7
Third edition
2014-09-01
Ophthalmic implants — Intraocular
lenses —
Part 7:
Clinical investigations
Implants ophtalmiques — Lentilles intraoculaires —
Partie 7: Investigations cliniques
Reference number
ISO 11979-7:2014(E)
©
ISO 2014
ISO 11979-7:2014(E)
© ISO 2014
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
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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Tel. + 41 22 749 01 11
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Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 11979-7:2014(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Justification for a clinical investigation . 1
5 Ethical considerations . 1
6 General requirements . 1
6.1 General . 1
6.2 Design . 2
6.3 Characteristics . 2
6.4 Investigation duration . 4
6.5 Enrollment . 4
6.6 Bilateral implantation . 4
6.7 Surgical technique . 4
6.8 Examination and treatment of subjects. 5
6.9 Adverse events reports . 5
6.10 Inclusion and exclusion criteria . 5
Annex A (informative) Elements of a clinical investigation . 7
Annex B (informative) Evaluation of post-operative adverse event and visual acuity rates .15
Annex C (informative) Additional elements for toric IOLs .19
Annex D (informative) Additional elements for accommodating IOLs .26
Annex E (informative) Clinical tests .35
Bibliography .41
ISO 11979-7:2014(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 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 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. 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 development of the document will be in the Introduction and/or
on the ISO list of patent declarations received. 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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the third edition (ISO 11979-7:2006), which has been technically
revised. It also incorporates the Amendment ISO 11979-7:2006/Amd1:2012 .
ISO 11979 consists of the following parts, under the general title Ophthalmic implants — Intraocular
lenses:
— Part 1: Vocabulary
— Part 2: Optical properties and test methods
— Part 3: Mechanical properties and test methods
— Part 4: Labelling and information
— Part 5: Biocompatibility
— Part 6: Shelf-life and transport stability testing
— Part 7: Clinical investigations
— Part 8: Fundamental requirements
— Part 9: Multifocal intraocular lenses
— Part 10: Phakic intraocular lenses
iv © ISO 2014 – All rights reserved

INTERNATIONAL STANDARD ISO 11979-7:2014(E)
Ophthalmic implants — Intraocular lenses —
Part 7:
Clinical investigations
1 Scope
This part of ISO 11979 specifies particular requirements for clinical investigations for posterior and
anterior chamber intraocular lenses (IOLs).
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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
ISO 11979-10, Ophthalmic implants — Intraocular lenses — Part 10: Phakic intraocular lenses
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11979-1 and ISO 14155 apply.
4 Justification for a clinical investigation
If the need for a clinical investigation is identified, the requirements of ISO 14155 shall apply, with
additional requirements given below.
If a new IOL model is a modification of a model for which the safety and performance have been
established through clinical investigation in accordance with this part of ISO 11979 no or limited
[1]
clinical investigation is needed. ISO/TR 22979 provides guidance in determining whether or not a
modification is minor.
5 Ethical considerations
...