SIST EN ISO 11987:2012

SLOVENSKI STANDARD
01-oktober-2012
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SIST EN ISO 11987:2000
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Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO 11987:2012)
Augenoptik - Kontaktlinsen - Bestimmung der Lagerdauer (ISO 11987:2012)
Optique ophtalmique - Lentilles de contact - Détermination de la durée de conservation
(ISO 11987:2012)
Ta slovenski standard je istoveten z: EN ISO 11987:2012
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 11987
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2012
ICS 11.040.70 Supersedes EN ISO 11987:1997
English Version
Ophthalmic optics - Contact lenses - Determination of shelf-life
(ISO 11987:2012)
Optique ophtalmique - Lentilles de contact - Détermination Augenoptik - Kontaktlinsen - Bestimmung der Lagerdauer
de la durée de conservation (ISO 11987:2012) (ISO 11987:2012)
This European Standard was approved by CEN on 14 July 2012.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11987:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 11987:2012) 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 January 2013, and conflicting national standards shall be withdrawn at
the latest by January 2013.
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 11987:1997.
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 11987:2012 has been approved by CEN as a EN ISO 11987:2012 without any modification.

INTERNATIONAL ISO
STANDARD 11987
Second edition
2012-07-15
Ophthalmic optics — Contact lenses —
Determination of shelf-life
Optique ophtalmique — Lentilles de contact — Détermination de la
durée de conservation
Reference number
ISO 11987:2012(E)
©
ISO 2012
ISO 11987:2012(E)
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.
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Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO 11987:2012(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 11987 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 11987:1997), which has been technically revised.
It also incorporates the Technical Corrigendum ISO 11987:1997/Cor.1:1998.
ISO 11987:2012(E)
Introduction
The tests included in this International Standard are designed to obtain information that enables proposals to
be made for the shelf-life of a contact lens, and storage conditions to be recommended. However, in practical
terms, it is the stability of the material from which the contact lens is made that is being tested, along with the
integrity of the packaging that maintains the environment necessary for the contact lens.
The purpose of the stability studies is to ascertain how the quality of the contact lens 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 can be recommended that guarantee the maintenance of the quality of the contact
lens in relation to its safety, efficacy and acceptability throughout the proposed shelf-life (i.e. during storage
and distribution until the moment of dispensing).
iv © ISO 2012 – All rights reserved

INTERNATIONAL STANDARD ISO 11987:2012(E)
Ophthalmic optics — Contact lenses — Determination of shelf-life
1 Scope
This International Standard specifies test procedures for determining the stability of contact lenses once they
are placed in their final packaging during storage and distribution.
NOTE The results obtained can be used for determining the expiry date.
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 18369-1, Ophthalmic optics ― Contact lenses ― Part 1: Vocabulary, classification system and
recommendations for labelling specifications
ISO 18369-2, Ophthalmic optics ― Contact lenses ― Part 2: Tolerances
ISO 18369-3, Ophthalmic optics ― Contact lenses ― Part 3: Measurement methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18369-1 apply.
4 Principle
The stability of contact lenses, packaging solution and packaging is established under controlled storage
conditions in order to determine their shelf-life under those conditions.
The design of the stability tests is based on the known properties of the material from which the contact lens is
made, the packaging system, and the recommendations for storing the contact lens.
5 General requirements and recommendations
A risk assessment shall be performed to evaluate the critical properties and parameters, and a test protocol prepared.
NOTE 1 A knowledge of the quantity and identity of extractable substances (see ISO 18369-4) is of particular help in
evaluating new contact lens materials and in determining the information that needs to be obtained from the stability testing.
The specifications of the properties and parameters evaluated in the stability study, which are claimed at the
time of manufacture and to the end of the proposed shelf-life, should reflect, as far as possible, the results of
the stability studies, particularly in relation to any parameters which could have a bearing on efficacy, safety
and product acceptability.
In designing stability tests, the manufacturer should consider any sterility requirements.
NOTE 2 Requirements for the development, validation and routine control of sterilization processes are described in
other International Standards. Additionally, sterility testing is described in monographs in various pharmacopoeias.
ISO 11987:2012(E)
6 Test and measurement media
6.1 The test medium shall be the contact lens storage solution, if any, that is used by the manufacturer for
packaging the contact lens.
6.2 Measurements shall be made either in the test medium (packaging solution), or in the standard saline
solution specified in ISO 18369-3 after equilibration in this solution, or dry. The same measurement medium
shall be used at all test stages. The choice of measurement medium shall be discussed in the risk assessment
and test protocol.
7 Apparatus
7.1 Controlled storage chamber, capable of being maintained at 25 °C ± 2 °C, and equipped with means
for continuously recording temperature and humidity.
Additional storage conditions, for example at 35 °C ± 2 °C and 45 °C ± 2 °C, may be required for accelerated studies.
Low relative humidity, for example 10 % RH to 20 % RH, can adversely affect products packed in semi-
permeable containers; consideration should be given to appropriate testing under such conditions.
7.2 Lens/lens packaging measuring equipment, as required, for the determination of back vertex power,
total diameter, curvature, spectral transmittance and other parameters of the lens and packaging system (to be
determined from the risk assessment). The equipment shall incorporate, if necessary, the ability to condition the
contact lens within the measurement media before and during measurement, under the controlled conditions
specified in the measurement method.
7.3 Solution measuring equipment, as required, to measure the properties of the packaging solution (to be
determined from the risk assessment).
8 Test samples
8.1 Test lenses shall be representative of the normal production. Th
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