EN ISO 11979-6:2007

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2007)

ISO 11979-6:2007 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.

Ophthalmische Implantate - Intraokularlinsen - Teil 6: Haltbarkeits- und Transportprüfungen (ISO 11979-6:2007)

Dieser Teil von ISO 11979 legt Prüfverfahren fest, mit denen die Haltbarkeit steriler Intraokularlinsen (IOLs) in ihrer Endverpackung bestimmt werden kann. Diese Prüfverfahren beinhalten Verfahren zur Bestimmung der Haltbarkeit von IOLs während Auslieferung und Lagerung.

Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Durée de conservation et stabilité pendant le transport (ISO 11979-6:2007)

L'ISO 11979-6:2007 spécifie les essais permettant de déterminer la durée de conservation des lentilles intraoculaires (LIO) stériles dans leur emballage final. Ces essais incluent des modes opératoires permettant de vérifier la stabilité des LIO pendant la distribution et le stockage.

Očesni vsadki (implantati) - Intraokularne leče - 6. del: Rok uporabnosti in odpornost pri prevozu (ISO 11979-6:2007)

General Information

• Status: Withdrawn
• Publication Date: 14-Jul-2007
• Withdrawal Date: 14-Oct-2014
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: ISO/TC 172 - ISO/TC 172
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 15-Oct-2014
• Ref Project: SIST EN ISO 11979-6:2008 - Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2007)

Relations

• Replaces: EN 13503-6:2002 - Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2002,modified)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11979-6:2014 - Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
• Effective Date: 15-Oct-2011

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-6:2008
01-april-2008
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO5RNXSRUDEQRVWLLQ
RGSRUQRVWSULSUHYR]X,62
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO
11979-6:2007)
Ophthalmische Implantate - Intraokularlinsen - Teil 6: Haltbarkeits- und
Transportprüfungen (ISO 11979-6:2007)
Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Durée de conservation et
stabilité pendant le transport (ISO 11979-6:2007)
Ta slovenski standard je istoveten z: EN ISO 11979-6:2007
ICS:
11.040.70
SIST EN ISO 11979-6:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 11979-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2007
ICS 11.040.70 Supersedes EN 13503-6:2002
English Version
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and
transport stability (ISO 11979-6:2007)
Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Ophthalmische Implantate - Intraokularlinsen - Teil 6:
Durée de conservation et stabilité pendant le transport (ISO Haltbarkeits- und Transportprüfungen (ISO 11979-6:2007)
11979-6:2007)
This European Standard was approved by CEN on 23 May 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-6:2007: E
worldwide for CEN national Members.

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EN ISO 11979-6:2007 (E)





Foreword


This document (EN ISO 11979-6:2007) 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 2008, and conflicting national
standards shall be withdrawn at the latest by January 2008.

This document supersedes EN 13503-6:2002.

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, 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 11979-6:2007 has been approved by CEN as EN ISO 11979-6:2007 without any
modifications.

2

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INTERNATIONAL ISO
STANDARD 11979-6
Second edition
2007-07-15

Ophthalmic implants — Intraocular
lenses —
Part 6:
Shelf-life and transport stability
Implants ophtalmiques — Lentilles intraoculaires —
Partie 6: Durée de conservation et stabilité pendant le transport




Reference number
ISO 11979-6:2007(E)
©
ISO 2007

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ISO 11979-6:2007(E)
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