EN ISO 11979-1:2012

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012)

DOR should have been 2012-09-29.
2012-04-03 EMA: Draft for // vote received in ISO/CS (see notification of 2012-04-02 in dataservice).
2011-06-01 EMA: Draft for // Enquiry received in ISO/TC (see notification of 2011-05-31 in dataservice)

Ophtalmische Implantate - Intraokularlinsen - Teil 1: Vokabular (ISO 11979-1:2012)

Dieser Teil von ISO 11979 legt Begriffe für Intraokularlinsen sowie für die Verfahren zu ihrer Prüfung fest.
ANMERKUNG   Die Begriffe werden in alphabetischer Reihenfolge angegeben.

Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Vocabulaire (ISO 11979-1:2012)

Očesni vsadki (implantati) - Intraokularne leče - 1. del: Slovar (ISO 11979-1:2012)

Ta del standarda ISO 11979 določa izraze, ki se uporabljajo za intraokularne leče in metode za njihovo ocenjevanje.

General Information

• Status: Withdrawn
• Publication Date: 14-Sep-2012
• Withdrawal Date: 11-Dec-2018
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 12-Dec-2018
• Ref Project: SIST EN ISO 11979-1:2012 - Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012)

Relations

• Replaces: EN ISO 11979-1:2006 - Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2006)
• Effective Date: 08-Oct-2012
• Replaced By: EN ISO 11979-1:2018 - Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2018)
• Effective Date: 19-Dec-2018

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2012
1DGRPHãþD
SIST EN ISO 11979-1:2006
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO6ORYDU,62
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012)
Ophtalmische Implantate - Intraokularlinsen - Teil 1: Vokabular (ISO 11979-1:2012)
Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Vocabulaire (ISO 11979-
1:2012)
Ta slovenski standard je istoveten z: EN ISO 11979-1:2012
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
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 11979-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2012
ICS 01.040.11; 11.040.70 Supersedes EN ISO 11979-1:2006
English Version
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
(ISO 11979-1:2012)
Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Ophtalmische Implantate - Intraokularlinsen - Teil 1:
Vocabulaire (ISO 11979-1:2012) Vokabular (ISO 11979-1:2012)
This European Standard was approved by CEN on 14 September 2012.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-1:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 11979-1:2012) 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 March 2013, and conflicting national standards shall be withdrawn at
the latest by March 2013.
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 11979-1:2006.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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 11979-1:2012 has been approved by CEN as a EN ISO 11979-1:2012 without any
modification.
INTERNATIONAL ISO
STANDARD 11979-1
NORME
Third edition
Troisième édition
INTERNATIONALE
2012-09-15
Ophthalmic implants — Intraocular
lenses —
Part 1:
Vocabulary
Implants ophtalmiques — Lentilles
intraoculaires —
Partie 1:
Vocabulaire
Reference number
Numéro de référence
ISO 11979-1:2012(E/F)
©
ISO 2012
ISO 11979-1:2012(E/F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT

©  ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester. / Droits de reproduction réservés. Sauf prescription différente, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris
la photocopie et les microfilms, sans l'accord écrit de l’ISO à l’adresse ci-après ou du comité membre de l’ISO dans le pays du
demandeur.
ISO copyright office
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland/Publié en Suisse

ii © ISO 2012 – All rights reserved/Tous droits réservés

ISO 11979-1:2012(E/F)
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 11979-1 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 11979-1:2006), which has been technically
revised.
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
 Part 7: Clinical investigations
 Part 8: Fundamental requirements
 Part 9: Multifocal intraocular lenses
 Part 10: Phakic intraocular lenses

ISO 11979-1:2012(E/F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux de
normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général confiée
aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire partie du
comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec
la Commission électrotechnique internationale (CEI) en ce qui concerne la normalisation électrotechnique.
Les Normes internationales sont rédigées conformément aux règles données dans les Directives ISO/CEI,
Partie 2.
La tâche principale des comités techniques est d'élaborer les Normes internationales. Les projets de Normes
internationales adoptés par les comités techniques sont soumis aux comités membres pour vote. Leur
publication comme Normes internationales requiert l'approbation de 75 % au moins des comités membres
votants.
L'attention est appelée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable de ne
pas avoir identifié de tels droits de propriété et averti de leur existence.
L'ISO 11979-1 a été élaborée par le comité technique ISO/TC 172, Optique et photonique, sous-comité SC 7,
Optique et instruments ophtalmiques.
Cette troisième édition annule et remplace la deuxième édition (ISO 11979-1:2006), qui a fait l'objet d'une
révision technique.
L'ISO 11979 comprend les parties suivantes, présentées sous le titre général Implants ophtalmiques —
Lentilles intraoculaires:
 Partie 1: Vocabulaire
 Partie 2: Propriétés optiques et méthodes d'essai
 Partie 3: Propriétés mécaniques et méthodes d'essai
 Partie 4: Étiquetage et informations
 Partie 5: Biocompatibilité
 Partie 6: Durée de conservation et stabilité pendant le transport
 Partie 7: Investigations cliniques
 Partie 8: Exigences fondamentales
 Partie 9: Lentilles intraoculaires multifocales
 Partie 10: Lentilles intraoculaires phaques

iv © ISO 2012 – All rights reserved/Tous droits réservés

INTERNATIONAL STANDARD
ISO 11979-1:2012(E/F)
NORME INTERNATIONALE
Ophthalmic implants — Implants ophtalmiques —
Intraocular lenses — Lentilles intraoculaires —
Part 1: Partie 1:
Vocabulary Vocabulaire
1 Scope 1 Domaine d'application
This part of ISO 11979 defines terms applicable to La présente partie de l'ISO 11979 définit les termes
intraocular lenses and to the methods used to applicables aux lentilles intraoculaires et aux
evaluate them. méthodes d'essai utilisées pour les évaluer.
NOTE  Terms are given alphabetically. NOTE  Les termes sont donnés par ordre alphabétique
de la version anglaise.
2 Terms and definitions 2 Termes et définitions
2.1 2.1
accelerated shelf-life study
étude en accéléré de la durée de conservation
stability study designed to increase the rate of modalités de stabilité définies pour augmenter la
chemical or physical degradation of a product by vitesse de dégradation physique ou chimique d'un
using exaggerated storage conditions (e.g. produit en utilisant des conditions de stockage
temperature, humidity) to determine kinetic exagérées (par exemple température, humidité) afin
degradation parameters to predict the tentative de déterminer des paramètres cinétiques de
expiration dating period dégradation pour définir une date de péremption
provisoire
2.2 2.2
accommodating intraocular lens lentille intraoculaire accommodative
AIOL LIOA
intraocular lens which provides continuous focusing lentille intraoculaire qui assure une mise au point
from far point to near point by changing the dioptric continue d'un point éloigné vers un point proche en
power of the eye modifiant la puissance dioptrique de l'œil
2.3 2.3
accommodative amplitude amplitude d'accommodation
difference in refractive power between the near différence de puissance de réfraction entre le point
point and the far point of the eye proche et le point éloigné de l’œil
2.4 2.4
additional wrapping emballage complémentaire
container used in addition to the primary packaging emballage utilisé en complément de l'emballage
and which could be used to maintain sterility of the primaire et qui peut éventuellement servir à
intraocular lens maintenir la stérilité de la lentille
ISO 11979-1:2012(E/F)
2.5 2.5
addition power puissance additionnelle
difference between the distance power and the near différence entre la puissance de vision de loin et la
power of the lens portion, measured under specified puissance de vision de près de la partie de la
conditions lentille, mesurée dans des conditions spécifiques
2.6 2.6
anterior chamber lens lentille de chambre antérieure
anterior chamber intraocular lens lentille intraoculaire de chambre antérieure
intraocular lens designed to be placed entirely in the lentille intraoculaire destinée à être placée
anterior chamber of the eye entièrement dans la chambre antérieure de l'œil
2.7 2.7
aspheric intraocular lens lentille intraoculaire asphérique
intraocular lens having at least one surface with a lentille intraoculaire ayant au moins une surface
monotonically continuously variable curvature from présentant une courbure à variation continue
the vertex to the periphery monotone depuis le sommet jusqu’à la périphérie
2.8 2.8
axis mark repère d'axe
indicator of the meridian of lowest optical power indicateur du méridien ayant la plus faible
puissance optique
2.9 2.9
best-case subject sujet idéal d'expérience
subject with no pre-operative ocular pathology, no sujet ne présentant pas de pathologie oculaire pré-
macular degeneration detected at any time, and no opératoire ni de dégénérescence maculaire, et sans
previous surgery for the correction of refractive antécédent chirurgical pour la correction d'erreurs
errors de réfraction
2.10 2.10
body corps
central part of an intraocular lens incorporating the partie centrale d'une lentille intraoculaire
optic comp
...

SLOVENSKI STANDARD
oSIST prEN ISO 11979-1:2011
01-oktober-2011
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO6ORYDU,62',6

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO/DIS 11979-1:2011)
Ophtalmische Implantate - Intraokularlinsen - Teil 1: Vokabular (ISO/DIS 11979-1:2011)
Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Vocabulaire (ISO/DIS 11979-
1:2011)
Ta slovenski standard je istoveten z: prEN ISO 11979-1
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 11979-1:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 11979-1:2011
oSIST prEN ISO 11979-1:2011
EUROPEAN STANDARD
DRAFT
prEN ISO 11979-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2011
ICS 01.040.11; 11.040.70 Will supersede EN ISO 11979-1:2006
English Version
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
(ISO/DIS 11979-1:2011)
Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Ophtalmische Implantate - Intraokularlinsen - Teil 1:
Vocabulaire (ISO/DIS 11979-1:2011) Vokabular (ISO/DIS 11979-1:2011)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 170.
If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

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.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 11979-1:2011: E
worldwide for CEN national Members.

oSIST prEN ISO 11979-1:2011
prEN ISO 11979-1:2011 (E)
Contents Page
Foreword .3

oSIST prEN ISO 11979-1:2011
prEN ISO 11979-1:2011 (E)
Foreword
This document (prEN ISO 11979-1:2011) 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 document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 11979-1:2006.
Endorsement notice
The text of ISO/DIS 11979-1:2011 has been approved by CEN as a prEN ISO 11979-1:2011 without any
modification.
oSIST prEN ISO 11979-1:2011
oSIST prEN ISO 11979-1:2011
DRAFT INTERNATIONAL STANDARD ISO/DIS 11979-1
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on Voting terminates on

2011-08-11 2012-01-11
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION    МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ    ORGANISATION INTERNATIONALE DE NORMALISATION

Ophthalmic implants — Intraocular lenses —
Part 1:
Vocabulary
Implants ophtalmiques — Lentilles intraoculaires —
Partie 1: Vocabulaire
[Revision of second edition (ISO 11979-1:2006)]
ICS 01.040.11; 11.040.70
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO 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.
©  International Organization for Standardization, 2011

oSIST prEN ISO 11979-1:2011
ISO/DIS 11979-1
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2011 – All rights reserved

oSIST prEN ISO 11979-1:2011
ISO/DIS 11979-1
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 General terms and definitions.1

oSIST prEN ISO 11979-1:2011
ISO/DIS 11979-1
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 11979-1 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 which has been technically revised.
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
⎯ Part 7: Clinical investigations
⎯ Part 8: Fundamental requirements
⎯ Part 9: Multifocal intraocular lenses
⎯ Part 10: Phakic intraocular lenses

iv © ISO 2011 – All rights reserved

oSIST prEN ISO 11979-1:2011
ISO/DIS 11979-1
Introduction
This part of ISO 11979 contains definitions of terms related to intraocular lenses and methods to evaluate
them.
Terms are given alphabetically.
At the time of publication, definitions quoted and acknowledged as being sourced from other International
Standards are identical to those in the referenced editions of these documents. If, due to future revision of
these International Standards, there should be disagreement between definitions in these International
Standards and those in ISO 13666, then the definitions in the latest version of the referenced documents take
precedence.
oSIST prEN ISO 11979-1:2011
oSIST prEN ISO 11979-1:2011
DRAFT INTERNATIONAL STANDARD ISO/DIS 11979-1

Ophthalmic implants — Intraocular lenses —
Part 1:
Vocabulary
1 Scope
This part of ISO 11979 defines terms applicable to intraocular lenses and to the methods used to evaluate
them.
2 General terms and definitions
2.1
accelerated shelf-life study
stability study designed to increase the rate of chemical or physical degradation of a product by using
exaggerated storage conditions (e.g. temperature, humidity) to determine kinetic degradation parameters to
predict the tentative expiration dating period
2.2
accommodating intraocular lens
AIOL
intraocular lens which provides continuous focusing from far point to near point by changing the dioptric power
of the eye
2.3
accommodative amplitude
difference in refractive power between the near point and the far point (measured in the corneal plane)
2.4
additional wrapping
container used in addition to the primary packaging and which could be used to maintain sterility of the
intraocular lens
2.5
addition power
difference between the distance power and the near power of the lens portion, measured under specified
conditions
2.6
anterior chamber lens
anterior chamber intraocular lens
intraocular lens designed to be placed entirely in the anterior chamber of the eye
2.7
aspheric intraocular lens
intraocular lens having a surface with a monotonically continuously variable curvature from the vertex to the
periphery
2.8
axis mark
indicator of the meridian of lowest optical power
oSIST prEN ISO 11979-1:2011
ISO/DIS 11979-1
2.9
base power
synonym to distance power, in ISO 11979-2 the term “far power” is used
2.10
best-case subject
subject with no pre-operative ocular pathology, no macular degeneration detected at any time, and no
previous surgery for the correction of refractive errors
2.11
body
central part of an intraocular lens incorporating the optic
NOTE See Figure 1.
2.12
clear optic
diameter of circle concentric with the optical axis of an intraocular lens, containing only features of the
intraocular lens belonging to the optical design
NOTE See Figure 1.
2.13
cumulative adverse events
total number of adverse events that have occurred at any time up to a specified time point post-operatively
2.14
custom-made device
any device specifically made in accordance with a duly qualified medical practitioner's written prescription,
which gives, under his responsibility, specific design characteristics and is intended for the sole use of a
particular patient
NOTE Mass-produced devices, which need to be adapted to meet the specific requirements of the medical
practitioner, are not considered to be custom-made devices.
2.15
cylindrical power
difference in dioptric power between the meridians with the highest and the lowest dioptric powers
2.16
device history record
collection of records and reports assembled in a batch package, containing, or referring to, the relevant
information pertaining to the manufacture and control of that batch of devices
2.17
device intended for clinical investigation
any device intended for use by a duly qualified medical practitioner when conducting a clinical investigation
2.18
dioptric power
reciprocal of the reduced paraxial focal length in situ for light with a wavelength of 546,07 nm, where paraxial
focal length is the distance between the back principal plane and the back paraxial focal point, and reduced
paraxial focal length is the paraxial focal length divided by the refractive index of the surrounding medium
−1
NOTE The unit for expressing dioptric power is the reciprocal metre (m ). The special name for this unit is “dioptre”
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