EN ISO 13212:2011

Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2011)

ISO 13212:2011 provides guidance on the design of stability studies for use in gathering information to enable determination of the shelf-life of contact lens care products.
ISO 13212:2011does not address studies designed to obtain information to establish the in-use stability (i.e. notice of discard date) of contact lens care products.

Augenoptik - Kontaktlinsenpflegemittel - Leitfaden für die Bestimmung der Lagerdauer (ISO 13212:2011)

Diese Internationale Norm gibt einen Leitfaden für die Auslegung von Stabilitätsuntersuchungen mit dem Ziel, Informationen betreffend die Bestimmung der Lagerdauer von Kontaktlinsenpflegemitteln zusammenzutragen, an. Sie gilt nicht für Untersuchungen, die darauf ausgerichtet sind, Informationen zur Stabilität von Kontaktlinsen-pflegemitteln während des Gebrauchs zu gewinnen (d. h. Informationen bezüglich der Aufbrauchfrist (en: discard date)).

Optique ophtalmique - Produits d'entretien pour lentilles de contact - Lignes directrices pour la détermination de la durée de conservation (ISO 13212:2011)

L'ISO 13212:2011 fournit des directives de conception des études de stabilité à utiliser pour réunir des informations permettant de déterminer la durée de conservation des produits d'entretien pour lentilles de contact.
L'ISO 13212:2011 ne s'applique pas aux études destinées à fournir des informations permettant d'établir la stabilité en cours d'utilisation (c'est-à-dire la déclaration de fin d'utilisation) des produits d'entretien pour lentilles de contact.

Očesna optika - Izdelki za vzdrževanje kontaktnih leč - Smernice za določanje roka uporabnosti (ISO 13212:2011)

Ta mednarodni standard zagotavlja vodilo za načrtovanje študij stabilnosti za uporabo in zbiranje informacij zato, da se omogoči določanje roka uporabnosti izdelkov za vzdrževanje kontaktnih leč. Ta mednarodni standard ne naslavlja študije, načrtovane za pridobitev informacij za določanje stabilnosti med uporabo (tj. obvestilo o roku uporabe) izdelkov za vzdrževanje kontaktnih leč.

General Information

• Status: Withdrawn
• Publication Date: 14-May-2011
• Withdrawal Date: 02-Sep-2014
• 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: 03-Sep-2014
• Ref Project: SIST EN ISO 13212:2011 - Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2011)

Relations

• Replaces: EN ISO 13212:1999 - Ophthalmic optics - Contact lens care products - Guidelines for the determination of shelf-life (ISO 13212:1999)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 13212:2014 - Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014)
• Effective Date: 27-Jun-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13212:2011
01-julij-2011
1DGRPHãþD
SIST EN ISO 13212:2000
2þHVQDRSWLND,]GHONL]DY]GUåHYDQMHNRQWDNWQLKOHþ6PHUQLFH]DGRORþDQMHURND
XSRUDEQRVWL,62
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
(ISO 13212:2011)
Augenoptik - Kontaktlinsenpflegemittel - Leitfaden für die Bestimmung der Lagerdauer
(ISO 13212:2011)
Optique ophtalmique - Produits d'entretien pour lentilles de contact - Lignes directrices
pour la détermination de la durée de conservation (ISO 13212:2011)
Ta slovenski standard je istoveten z: EN ISO 13212:2011
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 13212:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13212:2011

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SIST EN ISO 13212:2011


EUROPEAN STANDARD
EN ISO 13212

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2011
ICS 11.040.70 Supersedes EN ISO 13212:1999
English Version
Ophthalmic optics - Contact lens care products - Guidelines for
determination of shelf-life (ISO 13212:2011)
Optique ophtalmique - Produits d'entretien pour lentilles de Augenoptik - Kontaktlinsenpflegemittel - Leitfaden für die
contact - Lignes directrices pour la détermination de la Bestimmung der Lagerdauer (ISO 13212:2011)
durée de conservation (ISO 13212:2011)
This European Standard was approved by CEN on 14 May 2011.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13212:2011: E
worldwide for CEN national Members.

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SIST EN ISO 13212:2011
EN ISO 13212:2011 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 13212:2011
EN ISO 13212:2011 (E)
Foreword
This document (EN ISO 13212:2011) 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 November 2011, and conflicting national standards shall be withdrawn
at the latest by November 2011.
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 13212:1999.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, 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 the United Kingdom.
Endorsement notice
The text of ISO 13212:2011 has been approved by CEN as a EN ISO 13212:2011 without any modification.

3

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SIST EN ISO 13212:2011

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SIST EN ISO 13212:2011

INTERNATIONAL ISO
STANDARD 13212
Second edition
2011-05-15


Ophthalmic optics — Contact lens care
products — Guidelines for determination
of shelf-lif
...