SIST EN ISO 11979-1:2019

SLOVENSKI STANDARD
SIST EN ISO 11979-1:2019
01-marec-2019
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SIST EN ISO 11979-1:2012
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Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2018)
Ophthalmische Implantate - Intraokularlinsen - Teil 1: Vokabular (ISO 11979-1:2018)
Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Vocabulaire (ISO 11979-
1:2018)
Ta slovenski standard je istoveten z: EN ISO 11979-1:2018
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-1:2019

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SIST EN ISO 11979-1:2019


EN ISO 11979-1
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2018
EUROPÄISCHE NORM
ICS 01.040.11; 11.040.70 Supersedes EN ISO 11979-1:2012
English Version

Ophthalmic implants - Intraocular lenses - Part 1:
Vocabulary (ISO 11979-1:2018)
Implants ophtalmiques - Lentilles intraoculaires - Ophthalmische Implantate - Intraokularlinsen - Teil 1:
Partie 1: Vocabulaire (ISO 11979-1:2018) Vokabular (ISO 11979-1:2018)
This European Standard was approved by CEN on 20 October 2018.

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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-1:2018 E
worldwide for CEN national Members.

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SIST EN ISO 11979-1:2019
EN ISO 11979-1:2018 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11979-1:2019
EN ISO 11979-1:2018 (E)
European foreword
This document (EN ISO 11979-1:2018) 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 June 2019, and conflicting national standards shall be
withdrawn at the latest by June 2019.
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 11979-1:2012.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11979-1-2018 has been approved by CEN as EN ISO 11979-1:2018 without any
modification.

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SIST EN ISO 11979-1:2019

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SIST EN ISO 11979-1:2019
INTERNATIONAL ISO
STANDARD 11979-1
Fourth edition
2018-11
Ophthalmic implants — Intraocular
lenses —
Part 1:
Vocabulary
Implants ophtalmiques — Lentilles intraoculaires —
Partie 1: Vocabulaire
Reference number
ISO 11979-1:2018(E)
©
ISO 2018

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SIST EN ISO 11979-1:2019
ISO 11979-1:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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SIST EN ISO 11979-1:2019
ISO 11979-1:2018(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Abbreviated terms .10
© ISO 2018 – All rights reserved iii

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SIST EN ISO 11979-1:2019
ISO 11979-1:2018(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.
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 fourth edition cancels and replaces the third edition (ISO 11979-1:2012), which has been
technically revised.
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 © ISO 2018 – All rights reserved

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SIST EN ISO 11979-1:2019
INTERNATIONAL STANDARD ISO 11979-1:2018(E)
Ophthalmic implants — Intraocular lenses —
Part 1:
Vocabulary
1 Scope
This document defines terms applicable to intraocular lenses, and to the methods used to evaluate them.
NOTE Terms are listed in the alphabetical order of the English terms in the English version of this document.
2 Normative references
No normative references are given in this document.
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1.1
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
3.1.2
accommodating intraocular lens
AIOL
intraocular lens which provides continuous focusing from far point to near point by changing the
dioptric power of the eye
3.1.3
accommodative amplitude
difference in refractive power between the near point and the far point of the eye
3.1.4
additional wrapping
container used in addition to the primary packaging and which could be used to maintain sterility of
the intraocular lens
3.1.5
addition power
difference between the distance power and the near power of the lens portion, measured under
specified conditions
© ISO 2018 – All rights reserved 1

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SIST EN ISO 11979-1:2019
ISO 11979-1:2018(E)

3.1.6
anterior chamber lens
anterior chamber intraocular lens
intraocular lens designed to be placed entirely in the anterior chamber of the eye
3.1.7
aspheric intraocular lens
intraocular lens having at least one surface with a monotonically continuously variable curvature from
the vertex to the periphery
3.1.8
axis mark
indicator of the meridian of lowest optical power
3.1.9
base power
distance power
far power
power that is intended to provide an in-focus image of an object at far (infinite)
3.1.10
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
3.1.11
body
central part of an intraocular lens incorporating the optic
Note 1 to entry: See Figure 1.
2 © ISO 2018 – All rights reserved

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SIST EN ISO 11979-1:2019
ISO 11979-1:2018(E)

Key
1 overall diameter
2 positioning hole
3 clear optic
4 body
h vault height
1
h sagittal distance
2
Figure 1 — Overall diameter, vault height, sagittal distance, clear optic, body and
positioning hole
3.1.12
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 1 to entry: See Figure 1.
3.1.13
closed-loop IOL
IOL model, which contains two or more loops, each loop having both ends attached to the body of the optic
3.1.14
compression force
force exerted by the loops of the IOL when compressed to a given diameter
3.1.15
cumulative adverse events
total number of adverse events that have occurred at any time up to a specified time point post-
operatively
© IS
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