kSIST FprEN ISO 11979-4:2025

SLOVENSKI STANDARD
oSIST prEN ISO 11979-4:2025
01-maj-2025
Nadomešča:
SIST EN ISO 11979-4:2009/A1:2013
Očesni vsadki (implantati) - Intraokularne leče - 4. del: Označevanje in informacije
(ISO/DIS 11979-4:2025)
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO/DIS
11979-4:2025)
Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information
(ISO/DIS 11979-4:2025)
Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Étiquetage et informations
(ISO/DIS 11979-4:2025)
Ta slovenski standard je istoveten z: prEN ISO 11979-4
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 11979-4:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 11979-4:2025
oSIST prEN ISO 11979-4:2025
DRAFT
International
Standard
ISO/DIS 11979-4.2
ISO/TC 172/SC 7
Ophthalmic implants — Intraocular
Secretariat: DIN
lenses —
Voting begins on:
Part 4: 2025-03-24
Labelling and information
Voting terminates on:
2025-05-19
Implants ophtalmiques — Lentilles intraoculaires —
Partie 4: Étiquetage et informations
ICS: 11.040.70
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 11979-4.2:2025(en)
oSIST prEN ISO 11979-4:2025
DRAFT
ISO/DIS 11979-4.2:2025(en)
International
Standard
ISO/DIS 11979-4.2
ISO/TC 172/SC 7
Ophthalmic implants — Intraocular
Secretariat: DIN
lenses —
Voting begins on:
Part 4:
Labelling and information
Voting terminates on:
Implants ophtalmiques — Lentilles intraoculaires —
Partie 4: Étiquetage et informations
ICS: 11.040.70
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11979-4.2:2025(en)
ii
oSIST prEN ISO 11979-4:2025
ISO/DIS 11979-4.2:2025(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 General .1
4.2 Labelling .1
4.3 Instruction for Use .3
4.4 Self-adhesive label .5
5 Patient information materials . 5
5.1 General .5
5.2 Patient information leaflets (PIL) . .6
5.3 Patient implant card (PIC) .6
6 Use of symbols . 6
Bibliography . 7

iii
oSIST prEN ISO 11979-4:2025
ISO/DIS 11979-4.2:2025(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.
This third edition cancels and replaces the second edition (ISO 11979-4:2008), which has been technically
revised.
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
— instructions for use has been extended with the minimum requirements of the device description
including the abbreviations for the applicable SVIOL category according to ISO 11979-7:2024
— 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.

iv
oSIST prEN ISO 11979-4:2025
ISO/DIS 11979-4.2:2025(en)
Introduction
This document contains requirements and guidance for the labelling of intraocular lenses and the
information supplied with them.
[2]
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, some additional information is required
for intraocular lenses. This information concerns technical and optical data as well as information about
materials used.
v
oSIST prEN ISO 11979-4:2025
oSIST prEN ISO 11979-4:2025
DRAFT International Standard ISO/DIS 11979-4.2:2025(en)
Ophthalmic implants — Intraocular lenses —
Part 4:
Labelling and information
1 Scope
This document specifies the labelling requirements for intraocular lenses (IOLs) and the information to be
provided within or on the packaging.
NOTE This document attempts to harmonize the recognized labelling requirements for IOLs throughout the
world. However, there can be additional national requirements.
2 Normative references
The following referenced documents are indispensable for the application 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
ISO 11979-7:2024, Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular
lenses for the correction of aphakia
3 Terms and definitions
For the purposes of this document, the terms an
...