EN ISO 11979-2:2024
(Main)Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2024)
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2024)
This document specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with monofocal, toric, simultaneous vision, and/or accommodative optics. The generic descriptor ‘IOL’ used throughout this document also includes phakic intraocular lenses (PIOL).
Ophthalmische Implantate - Intraokularlinsen - Teil 2: Optische Eigenschaften und Prüfverfahren (ISO 11979-2:2024)
Dieses Dokument legt Anforderungen und Prüfverfahren für bestimmte optische Eigenschaften von Intraokularlinsen (IOL) mit monofokaler Optik, torischer Optik, einer Optik für simultanes Sehen und/oder akkommodierender Optik fest. Die allgemeine Bezeichnung „IOL“, die in diesem Dokument verwendet wird, schließt auch phake Intraokularlinsen (PIOL) ein.
Implants ophtalmiques - Lentilles intraoculaires - Partie 2: Propriétés optiques et méthodes d'essai (ISO 11979-2:2024)
Le présent document définit les exigences et les méthodes d’essai relatives à certaines propriétés optiques des lentilles intraoculaires (LIO) monofocales, toriques, à champ de vision simultané et/ou accommodatives. Le terme générique « LIO » utilisé dans le présent document inclut également les lentilles intraoculaires phaques (LIOP).
Očesni vsadki (implantati) - Intraokularne leče - 2. del: Optične lastnosti in preskusne metode (ISO/FDIS 11979-2:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 11979-2:2024
01-februar-2024
Očesni vsadki (implantati) - Intraokularne leče - 2. del: Optične lastnosti in
preskusne metode (ISO/DIS 11979-2:2023)
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
(ISO/DIS 11979-2:2023)
Ophthalmische Implantate - Intraokularlinsen - Teil 2: Optische Eigenschaften und
Prüfverfahren (ISO/DIS 11979-2:2023)
Implants ophtalmiques - Lentilles intraoculaires - Partie 2: Propriétés optiques et
méthodes d'essai (ISO/DIS 11979-2:2023)
Ta slovenski standard je istoveten z: prEN ISO 11979-2
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 11979-2:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 11979-2:2024
oSIST prEN ISO 11979-2:2024
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11979-2
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-11-23 2024-02-15
Ophthalmic implants — Intraocular lenses —
Part 2:
Optical properties and test methods
Implants ophtalmiques — Lentilles intraoculaires —
Partie 2: Propriétés optiques et méthodes d'essai
ICS: 11.040.70
This document is circulated as received from the committee secretariat.
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ISO/DIS 11979-2:2023(E)
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oSIST prEN ISO 11979-2:2024
ISO/DIS 11979-2:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11979-2
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
Ophthalmic implants — Intraocular lenses —
Part 2:
Optical properties and test methods
Implants ophtalmiques — Lentilles intraoculaires —
Partie 2: Propriétés optiques et méthodes d'essai
ICS: 11.040.70
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
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NATIONAL REGULATIONS.
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ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
oSIST prEN ISO 11979-2:2024
ISO/DIS 11979-2:2023(E)
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 . 5
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
oSIST prEN ISO 11979-2:2024
ISO/DIS 11979-2:2023(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
committees 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).
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 (see 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 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 11979-2:2014), 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),
extended depth of focus IOLs (EDF), and full visual range IOLs (FVR);
— Dioptric power, imaging quality, and characterization clauses and annexes were modified to include
requirements for SVIOLs;
-1 -1
— Respective units of mm and degree were adopted for linear and angular spatial frequencies per
ISO 9334;
— The resolution efficiency and associated annex have been removed from the this document due to
advancements in optical designs and the availability of modulation transfer function (MTF) imaging
quality measurement methods;
— A new normative annex, Annex C IOL – Characterization, has been added with associated
requirements for all IOL categories;
— Clarified description of UV cut-off wavelength;
— References were added to the bibliography.
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
oSIST prEN ISO 11979-2:2024
ISO/DIS 11979-2:2023(E)
Introduction
This part of ISO 11979 initially addressed monofocal IOLs and now includes the optical requirements
and test methods for monofocal, toric, simultaneous vision, and accommodating IOLs. This document
generally provides specific test methods and requirements connected to the optical function of
intraocular lenses. In some cases, test methods do not have specified requirements, including 1) the
spectral transmittance test that provides information related to UV transmission and potential exposure
situations, e.g., when using laser light sources for diagnosis and treatment; 2) optical characterization
testing that informs potential optical design risks and guide potential clinical investigation design. The
specified dioptric power and imaging quality limits result from the analysis of extensive interlaboratory
testing of the original spherical monofocal IOLs. Based on these studies, the respective dioptric power
repeatability and reproducibility were about 0,5 % and 1 %, respectively, of the dioptric power as
described in reference [1]. Additionally, for IOLs in the 10 D to 30 D range, the respective expected
imaging quality repeatability and reproducibility were 0,09 and 0,16 modulation transfer function
values as described in reference [2]. For other non-monofocal IOL designs, manufacturers should utilize
model-specific repeatability and reproducibility precision limits to establish reliable final release
criteria.
During the interlaboratory testing, some problems were encountered with measuring dioptric power,
as described in reference [1]. Specifically, the accuracy in determining dioptric power has an error that
is not negligible in relation to the half dioptre steps in which intraocular lenses are commonly labelled.
The dio
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