EN ISO 11981:2017
(Main)Ophthalmic optics - Contact lenses and contact lens care products -Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981:2017)
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
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Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2018
1DGRPHãþD
SIST EN ISO 11981:2009
2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHNRQWDNWQLKOHþ'RORþDQMH
IL]LNDOQH]GUXåOMLYRVWLL]GHONRY]DY]GUåHYDQMHNRQWDNWQLKOHþVNRQWDNWQLPLOHþDPL
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 11981:2017(E)
© 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
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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 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
INTERNATIONAL STANDARD ISO 11981:2017(E)
Ophthalmic optics — Contact lenses and contact lens care
products — Determination of physical compatibility of
contact lens care products with contact lenses
1 Scope
This document 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.
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 18369-1:2017, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and
recommendations for labelling specifications
ISO 18369-2, Ophthalmic optics — Contact lenses — Part 2: Tolerances
ISO 18369-3:2017, Ophthalmic optics — Contact lenses — Part 3: Measurement methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18369-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1
cycle
sequence of events, following instructions for use or recommendations by the manufacturer of the
contact lens care product, to occur between the time the contact lens is removed from the eye and
before it is placed back into the eye
3.2
standard saline solution
specific phosphate buffered saline at a pH of 7,4 ± 0,1 and a nominal osmolarity of 310 ± 5 mOsm
Note 1 to entry: The provisions for formulation and preparation of standard saline solution are given in
ISO 18369-3:2017, 4.9.
3.3
control solution
standard saline solution or appropriate justified alternative solution used to cycle contact lenses
Note 1 to entry: Control solutions are not required to comply with this document, but can be used to gain further
information about the test.
ISO 11981:2017(E)
4 Principle
4.1 Detection of changes in contact lens characteristics
See Figure 1.
a If the parameters are different from the values provided by the contact lens manufacturer, the new baseline
values should be used to compare results of test product.
Figure 1 — Flowchart for determination of physical compatibility of contact lens c
...
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