Ophthalmic optics - Contact lenses and contact lens care products -Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981:2017)

ISO 11981:2017 describes the general procedure and performance criteria for assessing the physical compatibility of contact lens care products with contact lenses and for determining whether the observed changes are reversible.

Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der physikalischen Verträglichkeit von Kontaktlinsenpflegemitteln mit Kontaktlinsen (ISO 11981:2017)

Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Détermination de la compatibilité physique des produits d'entretien des lentilles de contact avec les lentilles de contact (ISO 11981:2017)

ISO 19981:2017 décrit la procédure générale et les critères de performance permettant d'évaluer la compatibilité physique des produits d'entretien des lentilles de contact avec les lentilles de contact et de déterminer la réversibilité éventuelle des modifications observées.

Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Določanje fizikalne združljivosti izdelkov za vzdrževanje kontaktnih leč s kontaktnimi lečami (ISO 11981:2017)

Ta dokument opisuje splošni postopek in merila za zmogljivost za ocenjevanje fizikalne združljivosti proizvodov za vzdrževanje kontaktnih leč s kontaktnimi lečami in za določanje reverzibilnosti sprememb.

General Information

Status
Published
Publication Date
19-Dec-2017
Technical Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
20-Dec-2017
Completion Date
20-Dec-2017

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SLOVENSKI STANDARD
SIST EN ISO 11981:2018
01-februar-2018
1DGRPHãþD
SIST EN ISO 11981:2009

2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHNRQWDNWQLKOHþ'RORþDQMH

IL]LNDOQH]GUXåOMLYRVWLL]GHONRY]DY]GUåHYDQMHNRQWDNWQLKOHþVNRQWDNWQLPLOHþDPL

,62

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

physical compatibility of contact lens care products with contact lenses (ISO 11981:2017)

Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der

physikalischen Verträglichkeit von Kontaktlinsenpflegemitteln mit Kontaktlinsen (ISO

11981:2017)

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

- Détermination de la compatibilité physique des produits d'entretien des lentilles de

contact avec les lentilles de contact (ISO 11981:2017)
Ta slovenski standard je istoveten z: EN ISO 11981:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11981:2018 en

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

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SIST EN ISO 11981:2018
---------------------- Page: 2 ----------------------
SIST EN ISO 11981:2018
EN ISO 11981
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11981:2009
English Version
Ophthalmic optics - Contact lenses and contact lens care
products -Determination of physical compatibility of
contact lens care products with contact lenses (ISO
11981:2017)

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

d'entretien des lentilles de contact - Détermination de Kontaktlinsenpflegemittel - Bestimmung der

la compatibilité physique des produits d'entretien des physikalischen Verträglichkeit von

lentilles de contact avec les lentilles de contact (ISO Kontaktlinsenpflegemitteln mit Kontaktlinsen (ISO

11981:2017) 11981:2017)
This European Standard was approved by CEN on 4 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 11981:2017 E

worldwide for CEN national Members.
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SIST EN ISO 11981:2018
EN ISO 11981:2017 (E)
Contents Page

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

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SIST EN ISO 11981:2018
EN ISO 11981:2017 (E)
European foreword

This document (EN ISO 11981:2017) 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 11981:2009.

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 11981:2017 has been approved by CEN as EN ISO 11981:2017 without any modification.

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SIST EN ISO 11981:2018
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SIST EN ISO 11981:2018
INTERNATIONAL ISO
STANDARD 11981
Third edition
2017-11
Ophthalmic optics — Contact lenses
and contact lens care products
— Determination of physical
compatibility of contact lens care
products with contact lenses
Optique ophtalmique — Lentilles de contact et produits d'entretien des
lentilles de contact — Détermination de la compatibilité physique des
produits d'entretien des lentilles de contact avec les lentilles de contact
Reference number
ISO 11981:2017(E)
ISO 2017
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SIST EN ISO 11981:2018
ISO 11981:2017(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 11981:2018
ISO 11981:2017(E)
Contents Page

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

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

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

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

4 Principle ........................................................................................................................................................................................................................ 2

4.1 Detection of changes in contact lens characteristics.............................................................................................. 2

4.2 Method to distinguish reversible from irreversible changes in contact

lens characteristics .............................................................................................................................................................................. 3

5 Selection of test lenses ................................................................................................................................................................................... 4

6 Procedure..................................................................................................................................................................................................................... 4

6.1 Test method to detect changes in contact lens characteristics ..................................................................... 4

6.2 Test method to distinguish reversible from irreversible changes in contact

lens characteristics .............................................................................................................................................................................. 5

6.3 Interpretation of results ................................................................................................................................................................. 5

7 Test report ................................................................................................................................................................................................................... 5

Bibliography ................................................................................................................................................................................................................................ 7

© ISO 2017 – All rights reserved iii
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SIST EN ISO 11981:2018
ISO 11981:2017(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 11981:2009), which has been revised for

clarity and to update all normative references.
iv © ISO 2017 – All rights reserved
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SIST EN ISO 11981:2018
INTERNATIONAL STANDARD ISO 11981:2017(E)
Ophthalmic optics — Contact lenses and contact lens care
products — Determination of ph
...

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