EN ISO 11979-3:2012

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)

2011-06-01 EMA: Draft for // Enquiry received in ISO/TC (see notification of 2011-05-31 in dataservice)

Ophthalmische Implantate - Intraokularlinsen - Teil 3: Mechanische Eigenschaften und Prüfverfahren (ISO 11979-3:2012)

Dieser Teil von ISO 11979 legt Anforderungen und Prüfverfahren für bestimmte mechanische Eigenschaften
von Intraokularlinsen (IOLs) fest.
Er gilt mit der Ausnahme von Hornhautimplantaten für alle Typen von Intraokularlinsen, die für die Implantation
in das vordere Segment des menschlichen Auges vorgesehen sind, sofern das angegebene
Verfahren für das fragliche Design geeignet ist.

Implants ophtalmiques - Lentilles intraoculaires - Partie 3: Propriétés mécaniques et méthodes d'essai (ISO 11979-3:2012)

L'ISO 11979-3:2012 spécifie les exigences et les méthodes d'essai élaborées pour certaines propriétés mécaniques des lentilles intraoculaires (LIO).
L'ISO 11979-3:2012 s'applique à tous les types de LIO destinées à une implantation dans le segment antérieur de l'oeil humain, à l'exclusion des implants de la cornée, sous réserve que la méthode d'essai soit appropriée pour un modèle de LIO en particulier.

Očesni vsadki (implantati) - Intraokularne leče - 3. del: Mehanske lastnosti in preskusne metode (ISO 11979-3:2012)

Ta del standarda ISO 11979 določa zahteve in preskusne metode za nekatere mehanske lastnosti intraokularnih leč (IOL). Uporablja se za vse vrste intraokularnih leč za implantacijo v anteriorni segment človeškega očesa, razen za roženične vsadke, če je preskusna metoda ustrezna za posebno zasnovo intraokularne leče.

General Information

• Status: Published
• Publication Date: 30-Nov-2012
• Withdrawal Date: 29-Jun-2013
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Dec-2012
• Completion Date: 01-Dec-2012
• Ref Project: SIST EN ISO 11979-3:2013 - Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)

Relations

• Replaces: EN ISO 11979-3:2006 - Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2006)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-3:2013
01-marec-2013
1DGRPHãþD
SIST EN ISO 11979-3:2006
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO0HKDQVNHODVWQRVWLLQ
SUHVNXVQHPHWRGH,62
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test
methods (ISO 11979-3:2012)
Ophthalmische Implantate - Intraokularlinsen - Teil 3: Mechanische Eigenschaften und
Prüfverfahren (ISO 11979-3:2012)
Implants ophtalmiques - Lentilles intraoculaires - Partie 3: Propriétés mécaniques et
méthodes d'essai (ISO 11979-3:2012)
Ta slovenski standard je istoveten z: EN ISO 11979-3:2012
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-3:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-3:2013

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SIST EN ISO 11979-3:2013


EUROPEAN STANDARD
EN ISO 11979-3

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2012
ICS 11.040.70 Supersedes EN ISO 11979-3:2006
English Version
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical
properties and test methods (ISO 11979-3:2012)
Implants ophtalmiques - Lentilles intraoculaires - Partie 3: Ophthalmische Implantate - Intraokularlinsen - Teil 3:
Propriétés mécaniques et méthodes d'essai (ISO 11979- Mechanische Eigenschaften und Prüfverfahren (ISO
3:2012) 11979-3:2012)
This European Standard was approved by CEN on 30 November 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 11979-3:2012: E
worldwide for CEN national Members.

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SIST EN ISO 11979-3:2013
EN ISO 11979-3:2012 (E)
Contents Page
Foreword . 3

2

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SIST EN ISO 11979-3:2013
EN ISO 11979-3:2012 (E)
Foreword
This document (EN ISO 11979-3:2012) 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 June 2013, and conflicting national standards shall be withdrawn at
the latest by June 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 11979-3:2006.
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 11979-3:2012 has been approved by CEN as a EN ISO 11979-3:2012 without any
modification.

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SIST EN ISO 11979-3:2013

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SIST EN ISO 11979-3:2013
INTERNATIONAL ISO
STANDARD 11979-3
Third edition
2012-12-01
...