EN ISO 11986:2000

SLOVENSKI STANDARD
01-november-2000
2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHOHþ6PHUQLFH]D
GRORþDQMHSULY]HPDLQVSURVWLWYHVUHGVWYD]DNRQ]HUYLUDQMH,62
Ophthalmic optics - Contact lenses and contact lens care products - Guidelines for the
determination of preservative uptake and release (ISO 11986:1999)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Leitfaden für die Bestimmung
der Aufnahme und Wiederfreisetzung von Konservierungsmitteln (ISO 11986:1999)
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact
- Lignes directrices pour la détermination de l'absorption/adsorption et le relargage des
conservateurs (ISO 11986:1999)
Ta slovenski standard je istoveten z: EN ISO 11986:2000
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

INTERNATIONAL ISO
STANDARD 11986
First edition
1999-05-01
Ophthalmic optics — Contact lenses and
contact lens care products — Guidelines
for determination of preservative uptake
and release
Optique ophtalmique — Lentilles de contact et produits d'entretien pour
lentilles de contact — Lignes directrices pour la détermination de
l'absorption/adsorption et le relargage des conservateurs
A
Reference number
ISO 11986:1999(E)
ISO 11986:1999(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 3.
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.
International Standard ISO 11986 was prepared by Technical Committee ISO/TC 172, Optics and optical
instruments, Subcommittee SC 7, Ophthalmic optics and instruments.
©  ISO 1999
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 the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
ii
© ISO
ISO 11986:1999(E)
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 general guidance on 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 must be taken into consideration in selecting an appropriate analytical method. Contact lens uptake
and release data may 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.
iii
INTERNATIONAL STANDARD  © ISO ISO 11986:1999(E)
Ophthalmic optics — Contact lenses and contact lens care
products — Guidelines for determination of preservative uptake
and release
1 Scope
This International Standard provides guidance for the selection of methods, preparation of samples, and conduct of
testing for the uptake and release of preservatives from contact lenses.
NOTE Due to the manifest difficulties of reproducibly coating contact lenses with mineral and organic deposits, these
methods are only applicable to new and unused contact lenses.
2 Normative reference
The following normative document contains provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent edition of the normative document indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 10344, Optics and optical instruments — Contact lenses — Saline solution for contact lens testing.
3 Principle
The contact lenses to be tested are immersed in the test product at (25 ± 2) °C and the preservative content
analyzed 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 ISO Standard saline solution
(see ISO 10344) at (37 ± 2) °C for 15 h. The solution is analyzed for the amount of preservative that has been
extracted.
4 Procedure
4.1 General
The following information shall be obtained before commencing the estimation:
a) evidence, that the selected test method is suitable fo
...