SIST EN ISO 11979-4:2026

SLOVENSKI STANDARD
01-maj-2026
Nadomešča:
SIST EN ISO 11979-4:2009
SIST EN ISO 11979-4:2009/A1:2013
Očesni vsadki (implantati) - Intraokularne leče - 4. del: Označevanje in informacije
(ISO 11979-4:2026)
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-
4:2026)
Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information (ISO
11979-4:2026)
Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Étiquetage et informations
(ISO 11979-4:2026)
Ta slovenski standard je istoveten z: EN ISO 11979-4:2026
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11979-4
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2026
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11979-4:2008, EN ISO 11979-
4:2008/A1:2012
English Version
Ophthalmic implants - Intraocular lenses - Part 4:
Labelling and information (ISO 11979-4:2026)
Implants ophtalmiques - Lentilles intraoculaires - Ophthalmische Implantate - Intraokularlinsen - Teil 4:
Partie 4: Étiquetage et informations (ISO 11979- Etikettierung und Information (ISO 11979-4:2026)
4:2026)
This European Standard was approved by CEN on 20 February 2026.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-4:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11979-4:2026) 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 September 2026, and conflicting national standards
shall be withdrawn at the latest by September 2026.
Attention is 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 11979-4:2008.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11979-4:2026 has been approved by CEN as EN ISO 11979-4:2026 without any
modification.
International
Standard
ISO 11979-4
Third edition
Ophthalmic implants — Intraocular
2026-02
lenses —
Part 4:
Labelling and information
Implants ophtalmiques — Lentilles intraoculaires —
Partie 4: Étiquetage et informations
Reference number
ISO 11979-4:2026(en) © ISO 2026

ISO 11979-4:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 11979-4:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Labelling, instruction for use and labels . 1
4.1 Labelling .1
4.2 Instruction for use . .3
4.3 Self-adhesive label .5
4.4 Additional consideration for SVIOLs .5
5 Patient information materials . 6
5.1 General .6
5.2 Patient information leaflets (PIL) . .6
5.3 Patient implant card (PIC) .6
6 Use of symbols . 6
Bibliography . 7

iii
ISO 11979-4:2026(en)
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 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see 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, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 170, Ophthalmic optics, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 11979-4:2008), which has been technically
revised. It also incorporates the Amendment ISO 11979-4:2008/Amd.1:2012.
The main changes are as follows:
— normative references have been updated and retired standards have been removed or replaced;
— Table 1 has been updated with additional information to be included in the packaging; e.g. expiration
date on primary package;
— new categories and clinical requirements for SVIOLs were published in ISO 11979-7. ISO 11979-4 is
updated to reflect these changes also in labelling;
— information can be provided electronically if national regulations allow.
A list of all parts in the ISO 11979 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO 11979-4:2026(en)
Introduction
[5]
Labelling requirements for medical devices in general are given in ISO 20417 . However, in order to ensure
correct and necessary information to the ophthalmic surgeon, additional specific information is required
for intraocular lenses. Such information concerns technical and optical data as well as information about the
materials used.
...