Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO 11986:2017)

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.
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 11986:2017)

Diese Internationale Norm legt die allgemeine Vorgehensweise für die Auswahl von Prüfverfahren, die Vorbereitung von Prüfmustern und die Durchführung von Prüfungen der Aufnahme und Wiederfreisetzung von Konservierungsmitteln durch Kontaktlinsen fest.
ANMERKUNG 1   Aufgrund der offenkundigen Schwierigkeit, Kontaktlinsen in reproduzierbarer Weise mit mineralischen und organischen Ablagerungen, die beim Kontaktlinsentragen auftreten können, zu versehen, gelten diese Verfahren nur für neue und nicht benutzte Kontaktlinsen.
ANMERKUNG 2   Eine übermäßige Aufnahme des Konservierungsmittels aus dem begrenzten Volumen eines Kontakt¬linsen¬behälters durch eine Kontaktlinse könnte sich negativ auf die Desinfektionsleistung auswirken. Diese Internationale Norm behandelt nicht die Messung der Desinfektionsleistung.

Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Détermination de l'absorption/adsorption et du relargage des conservateurs (ISO 11986:2017)

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 11986:2017)

Ta dokument določa splošne postopke za izbiro metod, pripravo vzorcev in
izvajanje preskusov za prevzem in sproščanje zaščitnih sredstev iz kontaktnih leč.
OPOMBA 1: Zaradi očitnih težav s ponovljivostjo pri nanašanju mineralnih in organskih nanosov na kontaktne leče med njihovo obrabo se te metode uporabljajo samo za nove in neuporabljene kontaktne leče.
OPOMBA 2: Zmanjšanje količine zaščitnih sredstev zaradi kontaktne leče v omejenem prostoru škatlice za leče lahko ogrozi učinkovitost razkuževanja. Ta dokument ne obravnava merjenja učinkovitosti razkuževanja.

General Information

Status
Published
Public Enquiry End Date
19-Jan-2017
Publication Date
21-Jan-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
05-Jan-2018
Due Date
12-Mar-2018
Completion Date
22-Jan-2018

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SLOVENSKI STANDARD
SIST EN ISO 11986:2018
01-februar-2018
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SIST EN ISO 11986:2011

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Ophthalmic optics - Contact lenses and contact lens care products - Determination of

preservative uptake and release (ISO 11986:2017)

Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Aufnahme

und Wiederfreisetzung von Konservierungsmitteln (ISO 11986:2017)

Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact

- Détermination de l'absorption/adsorption et du relargage des conservateurs (ISO

11986:2017)
Ta slovenski standard je istoveten z: EN ISO 11986:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11986:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11986:2018
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SIST EN ISO 11986:2018
EN ISO 11986
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11986:2010
English Version
Ophthalmic optics - Contact lenses and contact lens care
products - Determination of preservative uptake and
release (ISO 11986:2017)

Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und

d'entretien pour lentilles de contact - Détermination de Kontaktlinsenpflegemittel - Bestimmung der Aufnahme

l'absorption/adsorption et du relargage des und Wiederfreisetzung von Konservierungsmitteln

conservateurs (ISO 11986:2017) (ISO 11986:2017)
This European Standard was approved by CEN on 21 November 2017.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey 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

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11986:2017 E

worldwide for CEN national Members.
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SIST EN ISO 11986:2018
EN ISO 11986:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 11986:2018
EN ISO 11986:2017 (E)
European foreword

This document (EN ISO 11986:2017) 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 June 2018, and conflicting national standards shall be

withdrawn at the latest by June 2018.

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 11986:2010.

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, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 11986:2017 has been approved by CEN as EN ISO 11986:2017 without any modification.

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SIST EN ISO 11986:2018
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SIST EN ISO 11986:2018
INTERNATIONAL ISO
STANDARD 11986
Third edition
2017-11
Ophthalmic optics — Contact lenses
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/adsorption
et du relargage des conservateurs
Reference number
ISO 11986:2017(E)
ISO 2017
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SIST EN ISO 11986:2018
ISO 11986:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 11986:2018
ISO 11986:2017(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Principle ........................................................................................................................................................................................................................ 1

5 Procedure..................................................................................................................................................................................................................... 1

5.1 General ........................................................................................................................................................................................................... 1

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

© ISO 2017 – All rights reserved iii
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SIST EN ISO 11986:2018
ISO 11986:2017(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.

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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on 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 the following

URL: 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.

This third edition cancels and replaces the second edition (ISO 11986:2010), which has been technically

revised.
The main changes compared to the previous edition are as follows:

— the cross references were aligned with the revised editions of ISO 18369-1 and ISO 18369-3;

— the expression of results in the test report has been clarified;
— editorial corrections have been applied.
iv © ISO 2017 – All rights reserved
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SIST EN ISO 11986:2018
ISO 11986:2017(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 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 cu
...

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