EN ISO 11979-10:2006

Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006)

ISO 11979-10:2006 is applicable to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye but excludes phakic IOLs (PIOLs) that utilize multifocal or other simultaneous vision optics to address presbyopic loss of accommodation and PIOLs that correct astigmatism.
ISO 11979-10:2006 addresses specific requirements for PIOLs not addressed in the other parts of ISO 11979.

Ophthalmische Implantate - Intraokularlinsen - Teil 10: Phake Intraokularlinsen (ISO 11979-10:2006)

Dieser Teil von ISO 11979 gilt für Intraokularlinsen (IOL), deren primäre Indikation die Modifikation der Brech¬kraft eines phaken Auges ist. Er gilt nicht für phake IOLs (PIOLs), die multifokale oder sonstige Optiken für das Simultan¬sehen zum Ausgleich eines presbyopen Akkomodationsverlustes einsetzen, sowie PIOL zur Korrektion von Astigmatismus.
Dieser Teil von ISO 11979 enthält besondere Anforderungen an PIOL, die in den übrigen Teilen von ISO 11979 nicht ent¬halten sind.

Implants ophtalmiques - Lentilles intraoculaires - Partie 10: Lentilles intraoculaires phaques (ISO 11979-10:2006)

L'ISO 11979-10:2006 s'applique à toute lentille intraoculaire (LIO), dont l'indication primaire est la modification de la puissance de réfraction d'un oeil phaque, mais exclut les LIO phaques (LIOP) qui utilisent des optiques multifocales ou à autre vision simultanée pour traiter la perte d'accommodation liée à la presbytie et les LIOP qui corrigent l'astigmatisme.
L'ISO 11979-10:2006 couvre les exigences spécifiques relatives aux LIOP qui ne sont pas abordées dans les autres parties de l'ISO 11979.

Očesni vsadki (implantati) - Intraokularne leče - 10. del: Intraokularne leče »phakic« (ISO 11979-10:2006)

General Information

• Status: Withdrawn
• Publication Date: 14-Aug-2006
• Withdrawal Date: 01-May-2018
• 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: 02-May-2018
• Ref Project: SIST EN ISO 11979-10:2006 - Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006)

Relations

• Replaced By: EN ISO 11979-10:2018 - Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
• Effective Date: 09-May-2018
• Amended By: EN ISO 11979-10:2006/A1:2014 - Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006/Amd 1:2014)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-10:2006
01-oktober-2006
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO,QWUDRNXODUQHOHþH
ªSKDNLF©,62
Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-
10:2006)
Ophthalmische Implantate - Intraokularlinsen - Teil 10: Phake Intraokularlinsen (ISO
11979-10:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 10: Lentilles intraoculaires
phaques (ISO 11979-10:2006)
Ta slovenski standard je istoveten z: EN ISO 11979-10:2006
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-10:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-10:2006

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SIST EN ISO 11979-10:2006
EUROPEAN STANDARD
EN ISO 11979-10
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2006
ICS 11.040.70

English Version
Ophthalmic implants - Intraocular lenses - Part 10: Phakic
intraocular lenses (ISO 11979-10:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 10: Ophthalmische Implantate - Intraokularlinsen - Teil 10:
Lentilles intraoculaires phaques (ISO 11979-10:2006) Phake Intraokularlinsen (ISO 11979-10:2006)
This European Standard was approved by CEN on 7 August 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
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 11979-10:2006: E
worldwide for CEN national Members.

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SIST EN ISO 11979-10:2006

EN ISO 11979-10:2006 (E)





Foreword


This document (EN ISO 11979-10:2006) 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 February 2007, and conflicting national
standards shall be withdrawn at the latest by February 2007.

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 11979-10:2006 has been approved by CEN as EN ISO 11979-10:2006 without
any modifications.

2

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SIST EN ISO 11979-10:2006


INTERNATIONAL ISO
STANDARD 11979-10
First edition
2006-08-15


Ophthalmic implants — Intraocular
lenses —
Part 10:
Phakic intraocular lenses
Implants ophtalmiques — Lentilles intraoculaires —
Partie 10: Lentilles intraoculaires phaques





Reference number
ISO 11979-10:2006(E)
©
ISO 2006

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SIST EN ISO 11979-10:2006
ISO 11979-10:2006(E)
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