EN ISO 11979-2:2014
(Main)Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014)
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014)
ISO 11979-2:2014 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or accommodative optics. The generic descriptor ?IOL' used throughout ISO 11979-2:2014 also includes phakic intraocular lenses (PIOL).
Ophthalmische Implantate - Intraokularlinsen - Teil 2: Optische Eigenschaften und Prüfverfahren (ISO 11979-2:2014)
Dieser Teil von ISO 11979 legt Anforderungen und Prüfverfahren für bestimmte optische Eigenschaften von sphärischen, asphärischen, torischen, multifokalen und akkommodierenden Intraokularlinsen (IOLs) fest. Die 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 11979-2:2014)
L'ISO 11979-2:2014 définit les exigences et les méthodes d'essai relatives à certaines propriétés optiques des lentilles intraoculaires (LIO) sphériques, asphériques, monofocales, toriques, multifocales et/ou progressives. Le terme générique «LIO» utilisé dans l'ISO 11979-2:2014 inclut également les lentilles intraoculaires phaques (LIOP).
Očesni vsadki (implantati) - Intraokularne leče - 2. del: Optične lastnosti in preskusne metode (ISO 11979-2:2014)
Standard EN ISO 11979-2 določa zahteve in preskusne metode za nekatere optične lastnosti intraokularnih leč (IOL) s sferično, asferično, torusno, večgoriščno in prilagodljivo optiko. Splošni izraz »intraokularne leče« ali »IOL«, ki se uporablja v tem dokumentu, zajema tudi fakične intraokularne leče (PIOL).
General Information
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Standards Content (Sample)
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01-november-2014
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SIST EN ISO 11979-2:2000/AC:2005
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Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
(ISO 11979-2:2014)
Ophthalmische Implantate - Intraokularlinsen - Teil 2: Optische Eigenschaften und
Prüfverfahren (ISO 11979-2:2014)
Implants ophtalmiques - Lentilles intraoculaires - Partie 2: Propriétés optiques et
méthodes d'essai (ISO 11979-2:2014)
Ta slovenski standard je istoveten z: EN ISO 11979-2:2014
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 11979-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2014
ICS 11.040.70 Supersedes EN ISO 11979-2:1999
English Version
Ophthalmic implants - Intraocular lenses - Part 2: Optical
properties and test methods (ISO 11979-2:2014)
Implants ophtalmiques - Lentilles intraoculaires - Partie 2: Ophthalmische Implantate - Intraokularlinsen - Teil 2:
Propriétés optiques et méthodes d'essai (ISO 11979- Optische Eigenschaften und Prüfverfahren (ISO 11979-
2:2014) 2:2014)
This European Standard was approved by CEN on 25 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 11979-2:2014 E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 11979-2:2014) 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 February 2015, and conflicting national standards shall be withdrawn
at the latest by February 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 11979-2:1999.
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 11979-2:2014 has been approved by CEN as EN ISO 11979-2:2014 without any modification.
INTERNATIONAL ISO
STANDARD 11979-2
Second edition
2014-08-15
Ophthalmic implants — Intraocular
lenses —
Part 2:
Optical properties and test methods
Implants ophtalmiques — Lentilles intraoculaires —
Partie 2: Propriétés optiques et méthodes d’essai
Reference number
ISO 11979-2:2014(E)
©
ISO 2014
ISO 11979-2:2014(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
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Published in Switzerland
ii © ISO 2014 – All rights reserved
ISO 11979-2:2014(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
4.3 Determination of imaging quality . 3
4.4 Spectral transmittance . 5
Annex A (normative) Measurement of dioptric power . 6
Annex B (normative) Measurement of resolution efficiency .14
Annex C (normative) Measurement of MTF .17
Bibliography .22
ISO 11979-2:2014(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
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.
ISO 11979-2 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 7, Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 11979-2:1999), which has been technically
revised. It also incorporates the Technical Corrigendum ISO 11979-2:1999/Cor.1:2003.
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
ISO 11979-2:2014(E)
Introduction
This part of ISO 11979 initially addressed monofocal IOLs and now has been revised to include the
requirements and test methods for spherical monofocal, aspheric monofocal, toric, multifocal, and
accommodative IOLs. This part of ISO 11979 contains several test methods for which associated
requirements are given and one test method for which no requirement is formulated. The former
are directly connected to the optical functions of intraocular lenses. The latter, the test for spectral
transmittance, has been provided for information about UV transmission and in specific situations, e.g.
when using laser light sources for diagnosis and treatment.
For the original spherical monofocal IOLs, extensive interlaboratory testing was carried out before
setting the limits specified. During this testing some basic problems were encountered as described in
Reference [1]. The accuracy in the determination of dioptric power has an error that is not negligible
in relation to the half dioptre steps in which intraocular lenses are commonly labelled. The dioptric
power tolerances take this fact into account. Hence the limits set may lead to some overlap into the next
labelled power, especially for high dioptre lenses. Reference [1] gives further discussion on this subject.
The majority of lenses hitherto implanted were qualified using the method described in Annex B or
Annex C (model eye 1). The method in Annex B is limited in its applicability, however. The limits for the
more general method in Annex C have been set in terms of MTF in a model eye, following two approaches.
The first is by correlation to the method and limit in Annex B. Further discussion can be found in
Reference [2]. The second is set as a percentage of what is calculated as theoretical maximum for the
design, with the rationale that a minimum level of manufacturing accuracy be guaranteed. For common
PMMA lenses, these two limits correspond well with each other. For lenses made of materials with lower
refractive index, or with certain shape factors, or for extreme power lenses in general, the latter limit
is lower than the former. However, such lenses are already in use, indicating clinical acceptance. The
question of which is the absolute lowest limit that is compatible with good vision arises. No definite
answer can be found, but following clinical data presented to the working group, an absolute lower limit
has been set for the calculation method.
INTERNATIONAL STANDARD ISO 11979-2:2014(E)
Ophthalmic implants — Intraocular lenses —
Part 2:
Optical properties and test methods
1 Scope
This part of ISO 11979 specifies requirements and test methods for certain optical properties
of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or
accommodative optics. The generic descriptor ‘IOL’ used throughout this document also includes phakic
intraocular lenses (PIOL).
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 6328:2000, Photography — Photographic materials — Determination of ISO resolving power
ISO 9334, Optics and photonics — Optical transfer function — Definitio
...
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