oSIST prEN ISO 11987:2025
(Main)Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO/DIS 11987:2025)
Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO/DIS 11987:2025)
ISO 11987:2012 specifies test procedures for determining the stability of contact lenses once placed in their final packaging during storage and distribution.
Augenoptik - Kontaktlinsen - Bestimmung der Lagerdauer (ISO/DIS 11987:2025)
Optique ophtalmique - Lentilles de contact - Détermination de la durée de conservation (ISO/DIS 11987:2025)
L'ISO 11987:2012 spécifie des modes opératoires d'essai permettant de déterminer la stabilité des lentilles de contact lorsqu'elles se trouvent dans leur emballage final, pendant le stockage et la distribution.
Očesna optika - Kontaktne leče - Določanje roka uporabnosti (ISO/DIS 11987:2025)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2025
Očesna optika - Kontaktne leče - Določanje roka uporabnosti (ISO/DIS 11987:2025)
Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO/DIS 11987:2025)
Augenoptik - Kontaktlinsen - Bestimmung der Lagerdauer (ISO/DIS 11987:2025)
Optique ophtalmique - Lentilles de contact - Détermination de la durée de conservation
(ISO/DIS 11987:2025)
Ta slovenski standard je istoveten z: prEN ISO 11987
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 11987
ISO/TC 172/SC 7
Ophthalmic optics — Contact lenses
Secretariat: DIN
— Determination of shelf-life
Voting begins on:
Optique ophtalmique — Lentilles de contact — Détermination de
2025-05-01
la durée de conservation
Voting terminates on:
ICS: 11.040.70 2025-07-24
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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Reference number
ISO/DIS 11987:2025(en)
DRAFT
ISO/DIS 11987:2025(en)
International
Standard
ISO/DIS 11987
ISO/TC 172/SC 7
Ophthalmic optics — Contact lenses
Secretariat: DIN
— Determination of shelf-life
Voting begins on:
Optique ophtalmique — Lentilles de contact — Détermination de
la durée de conservation
Voting terminates on:
ICS: 11.040.70
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11987:2025(en)
ii
ISO/DIS 11987:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
5 General requirements and recommendations. 2
6 Test and measurement media . 2
7 Apparatus . 2
8 Test samples . 2
9 Test procedure . 3
9.1 Real-time studies .3
9.2 Accelerated ageing studies .4
10 Expression of results . 5
11 Test report . 5
Bibliography . 7
iii
ISO/DIS 11987:2025(en)
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of patent.
ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect
thereof. As of the date of publication of this document, ISO had not received notice of patent which may be
required to implement this document. However, implementers are cautioned that this may not represent the
latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO
shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instrument.
This third edition cancels and replaces the second edition (ISO 11987:2012), which has been technically
revised.
The main changes are as follows:
— Editorial update of the whole document;
— An additional sentence in Clause 4 Principle clarifies the circumstances when the test method is to be
applied. In particular a variation of a lens design does not require a new shelf-life study.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO/DIS 11987:2025(en)
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).
v
DRAFT International Standard ISO/DIS 11987:2025(en)
Ophthalmic optics — Contact lenses — Determination of
shelf-life
1 Scope
This document 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 documents are referred to in the text in such a way that some or all of their content constitutes
requirements 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.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
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.
Stability assessment, with respect to contact lens, refers to material, not design. Having demonstrated the
stability of a single material and packaging system with one or more lens designs, risk assessments shall be
examined to determine whether or not additional stability testing should be performed for any substantial
change to lens designs.
ISO/DIS 11987:2025(en)
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, val
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