EN ISO 11986:2026

SLOVENSKI STANDARD
01-marec-2026
Očesna optika - Kontaktne leče in izdelki za vzdrževanje leč - Določanje privzema
in sprostitve sredstva za konzerviranje (ISO 11986:2026)
Ophthalmic optics - Contact lenses and contact lens care products - Determination of
preservative uptake and release (ISO 11986:2026)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Aufnahme
und Wiederfreisetzung von Konservierungsmitteln (ISO 11986:2026)
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact
- Détermination de l'absorption/adsorption et du relargage des conservateurs (ISO
11986:2026)
Ta slovenski standard je istoveten z: EN ISO 11986:2026
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11986
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2026
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11986:2017
English Version
Ophthalmic optics - Contact lenses and contact lens care
products - Determination of preservative uptake and
release (ISO 11986:2026)
Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und
d'entretien pour lentilles de contact - Détermination de Kontaktlinsenpflegemittel - Bestimmung der Aufnahme
l'absorption et de la libération des conservateurs (ISO und Wiederfreisetzung von Konservierungsmitteln
11986:2026) (ISO 11986:2026)
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 11986:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11986:2026) 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 11986:2017.
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 11986:2026 has been approved by CEN as EN ISO 11986:2026 without any modification.

International
Standard
ISO 11986
Fourth edition
Ophthalmic optics — Contact lenses
2026-01
and contact lens care products
— Determination of preservative
uptake and release
Optique ophtalmique — Lentilles de contact et produits
d'entretien pour lentilles de contact — Détermination de
l'absorption et de la libération des conservateurs
Reference number
ISO 11986:2026(en) © ISO 2026
ISO 11986:2026(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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 11986:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
5 Procedure . 2
5.1 General .2
5.2 Uptake of preservatives from test product .2
5.3 Release of preservatives from test lenses .3
6 Expression of results . 3
7 Test report . 4
Bibliography . 6

iii
ISO 11986:2026(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
patents. 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 patents
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 instruments, 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 fourth edition cancels and replaces the third edition (ISO 11986:2017), which has been technically
revised.
The main changes are as follows:
— Editorial update of the whole document.
— An additional sentence in the Scope clarifies the circumstances when the test method is to be applied. In
particular this test method is only considered for use during the development phase of new or modified
contact lens materials or new contact lens care products.
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 11986:2026(en)
Introduction
Contact lens care products are a complex mixture of organic and inorganic substances. For reasons of
microbiological safety, contact lens disinfecting solutions, as well as care products in multi-use containers,
contain substances with antimicrobial activity. From many years of experience in contact lens wear,
it is known that irritation and sensitization problems sometimes occur due to these preservatives being
absorbed and released by the matrix of the contact lens. For these reasons, it is necessary to be able to
estimate the extent of preservative uptake and release by contact lenses.
The preservative uptake and release test provides a general method for measuring the uptake of preservatives
in solution by contact lenses and the release of preservatives from contact lenses in an aqueous medium.
The analytical method to be used for quantification of specific preservatives is not indicated here. Chemical
characteristics of the preservative, as well as concentration in the contact lens care product and degree of
uptake by the contact lens, can be taken into consideration
...