SIST EN ISO 13212:2014

SLOVENSKI STANDARD
01-november-2014
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SIST EN ISO 13212:2011
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Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
(ISO 13212:2014)
Augenoptik - Kontaktlinsenpflegemittel - Leitfaden für die Bestimmung der Lagerdauer
(ISO 13212:2014)
Optique ophtalmique - Produits d'entretien pour lentilles de contact - Lignes directrices
pour la détermination de la durée de conservation (ISO 13212:2014)
Ta slovenski standard je istoveten z: EN ISO 13212:2014
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 13212
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2014
ICS 11.040.70 Supersedes EN ISO 13212:2011
English Version
Ophthalmic optics - Contact lens care products - Guidelines for
determination of shelf-life (ISO 13212:2014)
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 13212:2014)
durée de conservation (ISO 13212:2014)
This European Standard was approved by CEN on 14 May 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 13212:2014 E
worldwide for CEN national Members.

Contents
Page
Foreword .3

Foreword
This document (EN ISO 13212:2014) 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 March 2015, and conflicting national standards shall be withdrawn at
the latest by March 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 13212:2011.
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 13212:2014 has been approved by CEN as EN ISO 13212:2014 without any modification.
INTERNATIONAL ISO
STANDARD 13212
Third edition
2014-09-01
Ophthalmic optics — Contact lens
care products — Guidelines for
determination of shelf-life
Optique ophtalmique — Produits d’entretien pour lentilles de
contact — Lignes directrices pour la détermination de la durée de
conservation
Reference number
ISO 13212:2014(E)
©
ISO 2014
ISO 13212:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 13212:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 1
5 Determination of finished product stability . 1
5.1 Objective . 1
5.2 Study methods . 2
5.3 Description of the product under study . 3
5.4 Characteristics . 3
5.5 Evaluation methods . 4
5.6 Presentation of results . 4
5.7 Discussion, interpretation, and conclusions . 4
5.8 Ongoing stability . 5
Annex A (informative) Example of a stability testing plan for the finished contact lens
care product . 6
Bibliography . 7
ISO 13212:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 13212:2011), which has been technically
revised.
iv © ISO 2014 – All rights reserved

ISO 13212:2014(E)
Introduction
The purpose of stability tests of contact lens care products is to obtain sufficient information to enable
the manufacturer to establish an appropriate shelf-life and identify any unique storage conditions
required to appear on the labelling of the product.
The quality of a contact lens care product is determined by its content of active ingredient(s), its purity,
and its physicochemical and microbiological properties. It is important to take into account the possible
interaction of the container/closure with the contents.
The stability studies are intended to ascertain how the quality of a product varies as a function of time
and under the influence of a variety of environmental factors.
On the basis of the information obtained, storage conditions are recommended, which will guarantee
the maintenance of the quality of the product in relation to its safety, performance, and acceptability
throughout the proposed shelf-life.
The design of the finished product stability studies for a care product is based on the knowledge obtained
from studies on the active ingredient(s) and from the development studies.
INTERNATIONAL STANDARD ISO 13212:2014(E)
Ophthalmic optics — Contact lens care products —
Guidelines for determination of shelf-life
1 Scope
This International Standard 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.
This International Standard does not address studies designed to obtain information to establish the
in-use stability (i.e. notice of discard date) of contact lens care products.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 14729, Ophthalmic optics — Contact lens care products — Microbiological requirements and test
methods for products and regimens for hygienic management of contact lenses
ISO 14730, Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing
and guidance on determining discard date
ISO 18369-1, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and
recommendations for labelling specifications
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18369-1 apply.
4 General requirem
...