EN ISO 11979-6:2014

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)

ISO 11979-6:2014 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 11979-6:2014)

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 11979-6:2014)

L'ISO 11979-6:2014 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 obstojnost pri prevozu (ISO 11979-6:2014)

Ta del standarda ISO 11979 določa preskuse, s katerimi je mogoče določiti rok uporabnosti sterilnih intraokularnih leč (IOL) v končni embalaži. Ti preskusi vključujejo postopke za ugotavljanje obstojnosti intraokularnih leč pri prevozu in shranjevanju.

General Information

• Status: Published
• Publication Date: 14-Oct-2014
• Withdrawal Date: 29-Apr-2015
• 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: 15-Oct-2014
• Completion Date: 15-Oct-2014
• Ref Project: SIST EN ISO 11979-6:2015 - Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2014)

Relations

• Replaces: EN ISO 11979-6:2007 - Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2007)
• Effective Date: 15-Oct-2011

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-6:2015
01-januar-2015
1DGRPHãþD
SIST EN ISO 11979-6:2008
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO5RNXSRUDEQRVWLLQ
REVWRMQRVWSULSUHYR]X,62
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO
11979-6:2014)
Ophthalmische Implantate - Intraokularlinsen - Teil 6: Haltbarkeits- und
Transportprüfungen (ISO 11979-6:2014)
Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Durée de conservation et
stabilité pendant le transport (ISO 11979-6:2014)
Ta slovenski standard je istoveten z: EN ISO 11979-6:2014
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-6:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-6:2015

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SIST EN ISO 11979-6:2015

EUROPEAN STANDARD
EN ISO 11979-6

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2014
ICS 11.040.70 Supersedes EN ISO 11979-6:2007
English Version
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and
transport stability testing (ISO 11979-6:2014)
Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Ophthalmische Implantate - Intraokularlinsen - Teil 6:
Durée de conservation et stabilité pendant le transport (ISO Haltbarkeits- und Transportprüfungen (ISO 11979-6:2014)
11979-6:2014)
This European Standard was approved by CEN on 28 June 2014.

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

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-6:2014 E
worldwide for CEN national Members.

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SIST EN ISO 11979-6:2015
EN ISO 11979-6:2014 (E)
Contents
Page
Foreword .3
2

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SIST EN ISO 11979-6:2015
EN ISO 11979-6:2014 (E)
Foreword
This document (EN ISO 11979-6:2014) 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 April 2015, and conflicting national standards shall be withdrawn at the
latest by April 2015.
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 11979-6:2007.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, 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 11979-6:2014 has been approved by CEN as EN ISO 11979-6:2014 without any modification.
3

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SIST EN ISO 11979-6:2015

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SIST EN ISO 11979-6:2015
INTERNATIONAL ISO
STANDARD 11979-6
Th
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