EN ISO 13212:2011
(Main)Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
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.
INTERNATIONAL ISO
STANDARD 13212
Second edition
2011-05-15
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 13212:2011(E)
©
ISO 2011
ISO 13212:2011(E)
© ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing 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 2011 – All rights reserved
ISO 13212:2011(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 13212 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 13212:1999), of which it constitutes a minor
revision. In particular, the normative references have been updated.
ISO 13212:2011(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 for 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 thus 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.
iv © ISO 2011 – All rights reserved
INTERNATIONAL STANDARD ISO 13212:2011(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 referenced documents are indispensable for the application of this document. 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 requirements
4.1 The specified shelf-life of the contact lens care product shall be based on the evaluation of the results of
stability studies.
4.2 Analytical methods that have been validated and are stability-indicating shall be used to assay for active
ingredients. Validation includes, but is not limited to, being able to differentiate between the active ingredient
and its degradation products. The test methods used shall be described in full.
ISO 13212:2011(E)
5 Determination of finished-product stability
5.1 Objective
The objective of stability testing on contact lens care products is to provide data for determining the time
period during which the product performance characteristics are maintained and to define appropriate storage
conditions.
The design of the stability tests is based on the known properties of the active ingredient(s), the properties of
the chosen formulation and the recommendations for use of the product.
The relevant assay methods shall be determined prior to the start of the stability testing.
The specifications proposed from the time of manufacture to the end of the proposed shelf-life shall reflect, as
far as possible, the results of the stability studies, particularly in relation to any parameters which could have a
bearing on performance and safety and on product acceptability.
5.2 Study methods
5.2.1 General
Before starting stability studies, a suitable testing plan should be set up, taking into consideration the
properties of the active ingredient(s) as well as the proposed mode of action of the care product.
5.2.2 Real-time studies
These studies should be carried out under a range of controlled test conditions, when applicable, which will
enable the shelf-life and the storage requirements which are to appear on the product container label/package
insert to be defined. This will normally include studies which are intended to allow the properties of the product
at temperatures between 20 °C and 30 °C to be evaluated. However, 25 °C ± 2 °C should be used as the
mean kinetic testing temperature.
For each study, the mean temperature, the ranges of temperature and mean humidity, if applicable, shall be
stated in the stability report.
These studies are intended to support the initial shelf-life request and, for shelf-life extensions, any changes
that could significantly impact the safety and performance of the product (e.g. certain changes in formulation,
packaging materials or manufacturing methods).
NOTE Real-time studies are performed in conjunction with accelerated ageing studies to establish an initial shelf-life.
5.2.3 Studies under varying storage conditions
These studies shall be carried out to provide important additional information. They can fulfil a number of
objectives, such as
⎯ supporting the initial shelf-life request, by complementing the limited results of the early real-time studies,
because decomposition, if it occurs, is likely to be accelerated,
⎯ producing useful data at an early stage of development, demonstrating the effects of adverse storage in
the packaging and product, and enabling storage conditions and suitable labelling to be provided, and
⎯ supporting a request to extend the shelf-life.
2 © ISO 2011 – All rights reserved
ISO 13212:2011(E)
The various test conditions should be stated. Depending on the nature and objectives of the stability study, the
following points may need to be considered:
a) Various test temperatures: three or more, particularly if long-term real-time data are unavailable. In
addition, the effect of low temperatures may need to be considered, such as below −15 °C (freezer), 2 °C
to 8 °C (refrigerator) and freeze-thaw cycling.
b) High humidity: relative humidity > 75 %. Storage under high humidity conditions applies particularly to
solid dosage forms. For products such as solutions, suspensions, etc. contained in packs designed to
provide a permanent barrier to water loss, storage under high humidity is not necessary. However, low
humidity can have an adverse effect on products packaged in semi-permeable containers.
c) Elevated temperature and humidity in combination: e.g. temperature of 40 °C associated with a relative
humidity of 75 %, possibly with the effects of cycling between different temperatures and humidities.
d) Since most contact lens care products are water based, relative humidity less than 40 % should
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.