EN ISO 11979-2:2024

SLOVENSKI STANDARD
01-januar-2025
Nadomešča:
SIST EN ISO 11979-2:2014
Očesni vsadki (implantati) - Intraokularne leče - 2. del: Optične lastnosti in
preskusne metode (ISO 11979-2:2024)
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
(ISO 11979-2:2024)
Ophthalmische Implantate - Intraokularlinsen - Teil 2: Optische Eigenschaften und
Prüfverfahren (ISO 11979-2:2024)
Implants ophtalmiques - Lentilles intraoculaires - Partie 2: Propriétés optiques et
méthodes d'essai (ISO 11979-2:2024)
Ta slovenski standard je istoveten z: EN ISO 11979-2:2024
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11979-2
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2024
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11979-2:2014
English Version
Ophthalmic implants - Intraocular lenses - Part 2: Optical
properties and test methods (ISO 11979-2:2024)
Implants ophtalmiques - Lentilles intraoculaires - Ophthalmische Implantate - Intraokularlinsen - Teil 2:
Partie 2: Propriétés optiques et méthodes d'essai (ISO Optische Eigenschaften und Prüfverfahren (ISO 11979-
11979-2:2024) 2:2024)
This European Standard was approved by CEN on 1 November 2024.

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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-2:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11979-2:2024) 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 May 2025, and conflicting national standards shall be
withdrawn at the latest by May 2025.
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 11979-2:2014.
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 11979-2:2024 has been approved by CEN as EN ISO 11979-2:2024 without any
modification.
International
Standard
ISO 11979-2
Third edition
Ophthalmic implants — Intraocular
2024-10
lenses —
Part 2:
Optical properties and test methods
Implants ophtalmiques — Lentilles intraoculaires —
Partie 2: Propriétés optiques et méthodes d'essai
Reference number
ISO 11979-2:2024(en) © ISO 2024

ISO 11979-2:2024(en)
© ISO 2024
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 11979-2:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 1
4.1 General .1
4.2 Dioptric power .2
4.2.1 General .2
4.2.2 Dioptric power for toric IOL (TIOL) .2
4.2.3 Dioptric power for simultaneous vision IOL (SVIOL) .2
4.2.4 Dioptric power for accommodating IOL (AIOL) .3
4.3 Imaging quality .3
4.3.1 General .3
4.3.2 Monofocal IOL .4
4.3.3 Toric IOL (TIOL) .4
4.3.4 Simultaneous vision IOL (SVIOL) .4
4.3.5 Accommodating IOL (AIOL) .4
4.3.6 Combination of optical principles .4
4.3.7 Exceptions .4
4.4 Optical characterization .5
4.5 Spectral transmittance .5
4.5.1 Measurement of spectral transmittance .5
4.5.2 Cut-off wavelength .5
Annex A (normative) Measurement of dioptric power . 6
Annex B (normative) Measurement of MTF . 14
Annex C (normative) Optical characterization .18
Bibliography .21

iii
ISO 11979-2:2024(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 document 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 11979-2:2014), which has been technically
revised.
The main changes are as follows:
— A new category of simultaneous vision IOLs (SVIOL) is introduced for non-accommodating
lenses that provide simultaneous vision at multiple distances. It includes multifocal IOLs (MIOL),
e
...