EN ISO 11987:2026

Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO 11987:2026)

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.

Augenoptik - Kontaktlinsen - Bestimmung der Lagerdauer (ISO 11987:2026)

Dieses Dokument legt Prüfverfahren zur Bestimmung der Stabilität von Kontaktlinsen nach der Verpackung in ihren Endbehälter während der Lagerung und des Vertriebs fest.
ANMERKUNG   Die erzielten Ergebnisse können zur Festlegung des Verfallsdatums verwendet werden.

Optique ophtalmique - Lentilles de contact - Détermination de la durée de conservation (ISO 11987:2026)

Ce document spécifie les procédures d'essai pour déterminer la stabilité des lentilles de contact une fois qu'elles sont placées dans leur emballage final pendant le stockage et la distribution.
NOTE            Les résultats obtenus peuvent être utilisés pour déterminer la date de péremption.

Očesna optika - Kontaktne leče - Določanje roka uporabnosti (ISO 11987:2026)

Ta dokument določa preskusne postopke za določanje stabilnosti kontaktnih leč po pakiranju v končno embalažo med shranjevanjem in distribucijo. OPOMBA:            Pridobljene rezultate je mogoče uporabiti za določanje roka uporabnosti.

General Information

• Status: Published
• Publication Date: 20-Jan-2026
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 21-Jan-2026
• Completion Date: 21-Jan-2026
• Ref Project: SIST EN ISO 11987:2026 - Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO 11987:2026)

Relations

• Replaces: EN ISO 11987:2012 - Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO 11987:2012)
• Effective Date: 14-Aug-2024
• Refers: ISO 18369-1:2017 - Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
• Effective Date: 15-Apr-2026
• Refers: ISO 18369-3:2017 - Ophthalmic optics — Contact lenses — Part 3: Measurement methods
• Effective Date: 15-Apr-2026
• Refers: ISO 18369-2:2017 - Ophthalmic optics — Contact lenses — Part 2: Tolerances
• Effective Date: 15-Apr-2026
• Consolidated By: ISO 11987:2026 - Ophthalmic optics — Contact lenses — Determination of shelf-life
• Effective Date: 12-Feb-2026

Overview

EN ISO 11987:2026 - "Ophthalmic Optics - Contact Lenses - Determination of Shelf-life" is an international standard that establishes test procedures for evaluating the stability of contact lenses in their final packaging during storage and distribution. Developed by CEN and ISO technical committees specializing in optics and ophthalmic equipment, this standard provides a clear methodology for determining how long a contact lens product maintains its quality, with results supporting the assignment of expiry dates and recommended storage conditions.

Understanding the shelf-life of contact lenses is essential for manufacturers, regulatory bodies, and healthcare providers to ensure product safety, efficacy, and performance throughout storage and supply chain processes.

Key Topics

• Stability Testing: The standard outlines protocols for assessing the long-term stability of contact lens materials, packaging, and storage solutions under controlled conditions.
• Test Procedures: Both real-time and accelerated ageing studies are described to evaluate how environmental factors such as temperature and humidity may affect contact lens properties over time.
• Risk Assessment: Manufacturers are guided to conduct risk assessments to identify critical product properties, parameters, and the need for further testing based on variations in material or design.
• Measurement Criteria: The standard specifies that essential properties-such as back vertex power, diameter, curvature, and transmittance-are measured and compared to initial values using controlled and repeatable methodologies.
• Reporting Requirements: Clear guidance is provided for the documentation of test results, traceability of test lots, deviations, and risk assessment references.

Applications

The practical value of EN ISO 11987:2026 covers multiple areas:

• Manufacturing Quality Control: Contact lens manufacturers can utilize this standard to systematically validate product stability, ensuring that lenses remain compliant with their specifications throughout their declared shelf-life.
• Regulatory Compliance: Adherence to this standard facilitates conformity with European and international regulations for medical devices, supporting approval processes and market access.
• Expiry Date Determination: Test results obtained using the standard’s procedures serve as the scientific basis for establishing product expiry dates, which are critical for consumer safety and stock management.
• Supply Chain Assurance: Distributors and retailers rely on shelf-life data to manage inventory effectively and reduce the risk of supplying degraded or non-compliant products to the market.
• Packaging Evaluation: The standard emphasizes the importance of packaging integrity, helping manufacturers select appropriate packaging materials and processes that preserve product quality.

Related Standards

EN ISO 11987:2026 should be used in conjunction with several other relevant standards for a comprehensive approach to contact lens quality and safety:

• ISO 18369 Series:

  • ISO 18369-1: Vocabulary, classification, and labeling recommendations for contact lenses
  • ISO 18369-2: Tolerances for contact lenses
  • ISO 18369-3: Measurement methods for contact lenses
  • ISO 18369-4: Physicochemical properties of lens materials

• ISO 11607 Series:

  • ISO 11607-1 & -2: Requirements and validation for packaging systems of terminally sterilized medical devices

• Pharmacopoeias:

  • European Pharmacopoeia, United States Pharmacopeia, and Japanese Pharmacopoeia for sterility testing and solution properties

By following EN ISO 11987:2026, stakeholders in the ophthalmic device sector can ensure contact lenses are safe, effective, and meet all necessary regulatory and consumer expectations regarding shelf-life and quality.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2026
Očesna optika - Kontaktne leče - Določanje roka uporabnosti (ISO 11987:2026)
Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO 11987:2026)
Augenoptik - Kontaktlinsen - Bestimmung der Lagerdauer (ISO 11987:2026)
Optique ophtalmique - Lentilles de contact - Détermination de la durée de conservation
(ISO 11987:2026)
Ta slovenski standard je istoveten z: EN ISO 11987:2026
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11987
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2026
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11987:2012
English Version
Ophthalmic optics - Contact lenses - Determination of
shelf-life (ISO 11987:2026)
Optique ophtalmique - Lentilles de contact - Augenoptik - Kontaktlinsen - Bestimmung der
Détermination de la durée de conservation (ISO Lagerdauer (ISO 11987:2026)
11987:2026)
This European Standard was approved by CEN on 29 December 2025.

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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11987:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11987:2026) 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 July 2026, and conflicting national standards shall be
withdrawn at the latest by July 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11987:2012.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11987:2026 has been approved by CEN as EN ISO 11987:2026 without any modification.

International
Standard
ISO 11987
Third edition
Ophthalmic optics — Contact lenses
2026-01
— Determination of shelf-life
Optique ophtalmique — Lentilles de contact — Détermination de
la durée de conservation
Reference number
ISO 11987:2026(en) © ISO 2026
ISO 11987:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 11987:2026(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 11987:2026(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, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 170, Ophthalmic optics, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
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 clarifies the circumstances when the test method has 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 11987:2026(en)
Introduction
The tests included in this document 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
International Standard ISO 11987:2026(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 additiona
...