EN ISO 11979-1:2006

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2006)

ISO 11979-1:2006 defines terms applicable to intraocular lenses and to the methods used to evaluate them.

Ophthalmische Implantate - Intraokularlinsen - Teil 1: Vokabular (ISO 11979-1:2006)

Dieser Teil von ISO 11979 legt Begriffe für Intraokularlinsen sowie für die Verfahren zu ihrer Prüfung fest.

Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Vocabulaire (ISO 11979-1:2006)

L'ISO 11979-1:2006 définit les termes applicables aux lentilles intraoculaires et aux méthodes d'essai utilisées pour les évaluer.

Očesni vsadki (implantati) - Intraokularne leče - 1. del: Slovar (ISO 11979-1:2006)

General Information

• Status: Withdrawn
• Publication Date: 14-Jul-2006
• Withdrawal Date: 14-Sep-2012
• 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
• Start Date: 15-Sep-2012
• Completion Date: 15-Sep-2012
• Ref Project: SIST EN ISO 11979-1:2006 - Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2006)

Relations

• Replaces: EN ISO 11979-1:1999 - Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:1999)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11979-1:2012 - Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012)
• Effective Date: 08-Oct-2012

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2006
1DGRPHãþD
SIST EN ISO 11979-1:2000
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO6ORYDU,62
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2006)
Ophthalmische Implantate - Intraokularlinsen - Teil 1: Vokabular (ISO 11979-1:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Vocabulaire (ISO 11979-
1:2006)
Ta slovenski standard je istoveten z: EN ISO 11979-1:2006
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
July 2006
ICS 11.040.70; 01.040.11 Supersedes EN ISO 11979-1:1999
English Version
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
(ISO 11979-1:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Ophthalmische Implantate - Intraokularlinsen - Teil 1:
Vocabulaire (ISO 11979-1:2006) Vokabular (ISO 11979-1:2006)
This European Standard was approved by CEN on 14 July 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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.
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EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-1:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 11979-1:2006) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" 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 January 2007, and conflicting national
standards shall be withdrawn at the latest by January 2007.

This document supersedes EN ISO 11979-1:1999.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
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.

Endorsement notice
The text of ISO 11979-1:2006 has been approved by CEN as EN ISO 11979-1:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 11979-1
NORME
Second edition
Deuxième édition
INTERNATIONALE
2006-07-15
Ophthalmic implants — Intraocular
lenses —
Part 1:
Vocabulary
Implants ophtalmiques — Lentilles
intraoculaires —
Partie 1:
Vocabulaire
Reference number
Numéro de référence
ISO 11979-1:2006(E/F)
©
ISO 2006
ISO 11979-1:2006(E/F)
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ii © ISO 2006 – All rights reserved/Tous droits réservés

ISO 11979-1:2006(E/F)
Contents Page
Foreword. v
Introduction . vii
1 Scope. 1
2 General terms and definitions. 1
3 Terms related to optical properties and their test methods (ISO 11979-2). 3
4 Terms related to mechanical properties and their test methods (ISO 11979-3) . 5
5 Terms related to labelling and information (ISO 11979-4).6
6 Terms related to biocompatibility (ISO 11979-5) . 7
7 Terms related to shelf-life and transport stability (ISO 11979-6). 8
8 Terms related to clinical investigation (ISO 11979-7) . 9
9 Terms related to multifocal intraocular lenses (ISO 11979-9). 10
Alphabetical index . 11
French alphabetical index (Index alphabétique). 12

ISO 11979-1:2006(E/F)
Sommaire Page
Avant-propos.vi
Introduction .viii
1 Domaine d'application.1
2 Termes généraux et définitions.1
3 Termes relatifs aux propriétés optiques et à leurs méthodes d'essai (ISO 11979-2) .3
4 Termes relatifs aux propriétés mécaniques et à leurs méthodes d'essai (ISO 11979-3) .5
5 Termes relatifs à l'étiquetage et aux informations (ISO 11979-4) .6
6 Termes relatifs à la biocompatibilité (ISO 11979-5).7
7 Termes relatifs à la durée de conservation et à la stabilité pendant le transport (ISO 11979-6).8
8 Termes relatifs aux investigations cliniques (ISO 11979-7) .9
9 Termes relatifs aux lentilles intraoculaires multifocales (ISO 11979-9).10
Index alphabétique anglais (Alphabetical index) .11
Index alphabétique.12

iv © ISO 2003 – All rights reserved/Tous droits réservés

ISO 11979-1:2006(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 second edition cancels and replaces the first edition (ISO 11979-1:1999), 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 11979-1:2006(E/F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux de
normalisation (comités me
...