prEN ISO 11986
(Main)Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO/DIS 11986:2025)
Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO/DIS 11986:2025)
ISO 11986:2017 provides general procedures for the selection of methods, preparation of samples, and the conduct of testing for the uptake and release of preservatives from contact lenses.
NOTE 1 Due to the manifest difficulties of reproducibility when coating contact lenses with mineral and organic deposits encountered during lens wear, these methods are only applicable to new and unused contact lenses.
NOTE 2 Preservative depletion by a contact lens in the limited volume of a lens case could compromise disinfection performance. This document does not measure disinfection performance.
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Aufnahme und Wiederfreisetzung von Konservierungsmitteln (ISO/DIS 11986:2025)
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Détermination de l'absorption/adsorption et du relargage des conservateurs (ISO/DIS 11986:2025)
ISO 11986:2017 fournit des modes opératoires généraux pour sélectionner les différentes méthodes, préparer les échantillons et réaliser des essais portant sur l'absorption/adsorption et le relargage des conservateurs par les lentilles de contact.
NOTE 1 En raison des difficultés évidentes rencontrées pour obtenir de façon reproductible des dépôts minéraux et organiques à la surface des lentilles de contact en cours de port, les présentes méthodes s'appliquent uniquement aux lentilles de contact neuves n'ayant jamais été utilisées.
NOTE 2 L'appauvrissement en conservateurs pour une lentille de contact placée dans le volume limité d'un étui à lentilles pourrait altérer les performances de décontamination. Le présent document ne mesure pas les performances de décontamination.
Očesna optika - Kontaktne leče in izdelki za vzdrževanje leč - Določanje privzema in sprostitve sredstva za konzerviranje (ISO/DIS 11986:2025)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2025
Očesna optika - Kontaktne leče in izdelki za vzdrževanje leč - Določanje privzema
in sprostitve sredstva za konzerviranje (ISO/DIS 11986:2025)
Ophthalmic optics - Contact lenses and contact lens care products - Determination of
preservative uptake and release (ISO/DIS 11986:2025)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Aufnahme
und Wiederfreisetzung von Konservierungsmitteln (ISO/DIS 11986:2025)
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact
- Détermination de l'absorption/adsorption et du relargage des conservateurs (ISO/DIS
11986:2025)
Ta slovenski standard je istoveten z: prEN ISO 11986
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 11986
ISO/TC 172/SC 7
Ophthalmic optics — Contact lenses
Secretariat: DIN
and contact lens care products
Voting begins on:
— Determination of preservative
2025-05-01
uptake and release
Voting terminates on:
2025-07-24
Optique ophtalmique — Lentilles de contact et produits
d'entretien pour lentilles de contact — Détermination de
l'absorption/adsorption et du relargage des conservateurs
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.
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Reference number
ISO/DIS 11986:2025(en)
DRAFT
ISO/DIS 11986:2025(en)
International
Standard
ISO/DIS 11986
ISO/TC 172/SC 7
Ophthalmic optics — Contact lenses
Secretariat: DIN
and contact lens care products
Voting begins on:
— Determination of preservative
uptake and release
Voting terminates on:
Optique ophtalmique — Lentilles de contact et produits
d'entretien pour lentilles de contact — Détermination de
l'absorption/adsorption et du relargage des conservateurs
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
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Published in Switzerland Reference number
ISO/DIS 11986:2025(en)
ii
ISO/DIS 11986:2025(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/DIS 11986:2025(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
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 photonics.
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/DIS 11986:2025(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 in selecting an appropriate analytical method.
Contact lens uptake and release data can be useful in characterizing the potential for a new or modified
contact lens material to produce a toxic or irritating reaction in the eye from the uptake and binding or
release of preservatives from currently marketed contact lens care products.
v
DRAFT International Standard ISO/DIS 11986:2025(en)
Ophthalmic optics — Contact lenses and contact lens care
products — Determination of preservative uptake and release
1 Scope
This document provides general procedures for the selection of methods, preparation of samples, and the
conduct of testing for the uptake and release of preservatives from contact lenses.
Preservative uptake and release testing is not intended as a routine test of production contact lenses or
contact lens care products nor are testing results meant to establish finished goods specifications in any way.
Such testing is carried out when developing new contact lens materials and/or contact lens care products.
NOTE 1 Due to the manifest difficulties of reproducibility when coating contact lenses with mineral and organic
deposits encountered during lens wear, these methods are only applicable to new and unused contact lenses.
NOTE 2 Preservative depletion by a contact lens in the limited volume of a lens case could compromise disinfection
performance. This document does not measure disinfection performance.
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 18369-3, Ophthalmic optics — Contact lenses — Part 3: Measurement methods
3 Terms and definitions
No terms and definitions are listed in this document.
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 contact lenses to be tested are immersed in the test product at 25 °C ± 2 °C and the preservative content
is analysed at regular intervals of time until a steady-state condition has been achieved.
After reaching the steady-state condition, each contact lens is immersed in 1 ml of saline solution for
contact lens testing, the saline solution is prepared in accordance with ISO 183693:2017, 4.9, at 37 °C ± 2 °C.
At discrete intervals up to and including 16 h, and at intervals until no additional release is observed, if
required, the solution is analysed for the amount of preservative that has been extracted at each time point.
ISO/DIS 11986:2025(en)
5 Procedure
5.1 General
The following information sh
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