EN ISO 11981:1999

Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981:1999)

Specification of uniform test methods in order to achieve comparable test results.

Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der physikalischen Verträglichkeit von Kontaktlinsenpflegemitteln mit Kontaktlinsen (ISO 11981:1999)

Diese Internationale Norm beschreibt Verfahren zur Bestimmung der physikalischen Verträglichkeit von Kontaktlinsenpflegemitteln mit Kontaktlinsen und zur Feststellung, ob die beobachteten Veränderungen reversibel sind.

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 11981:1999)

Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Ugotavljanje fizikalne združljivosti izdelkov za vzdrževanje kontaktnih leč s kontaktnimi lečami (ISO 11981:1999)

General Information

• Status: Withdrawn
• Publication Date: 31-May-1999
• Withdrawal Date: 30-Jun-2009
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Jul-2009
• Completion Date: 01-Jul-2009
• Ref Project: SIST EN ISO 11981:2000 - Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981:1999)

Relations

• Replaced By: EN ISO 11981:2009 - Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981:2009)
• Effective Date: 04-Jul-2009
• Corrected By: EN ISO 11981:1999/AC:2009 - Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981:1999/Cor 1:2005)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11981:2000
01-julij-2000
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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 11981:1999)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der
physikalischen Verträglichkeit von Kontaktlinsenpflegemitteln mit Kontaktlinsen (ISO
11981:1999)
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 11981:1999)
Ta slovenski standard je istoveten z: EN ISO 11981:1999
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11981:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11981:2000

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SIST EN ISO 11981:2000

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SIST EN ISO 11981:2000

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SIST EN ISO 11981:2000

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SIST EN ISO 11981:2000
INTERNATIONAL ISO
STANDARD 11981
First edition
1999-06-01
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
A
Reference number
ISO 11981:1999(E)

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SIST EN ISO 11981:2000
ISO 11981:1999(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 11981 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 [e-mail]
Printed in Switzerland
ii

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SIST EN ISO 11981:2000
INTERNATIONAL STANDARD  © ISO ISO 11981:1999(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 International Standard 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 normative documents contain 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 editions of the normative documents 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.
1)
ISO 8320-1:— , Ophthalmic optics — Vocabulary on contact lenses and contact lens care products — Part 1:
Contact lenses.
1)
ISO 8320-2:— ,
Ophthalmic optics — Vocabulary on contact lenses and contact lens care products — Part 2:
Contact lens care products.
ISO 8321-1:1991, Optics and optical instruments — Contact lenses — Part 1: Specifications for rigid corneal and
scleral contact lenses.
2)
ISO 8321-2:— , Optics and optical instruments — Contact lenses — Part 2: Specifications for single-vision
hydrogel contact lenses.
ISO 8599:1994, Optics and optical instruments — Contact lenses — Determination of the spectral and luminous
transmittances.
ISO 9337-1:1999, Ophthalmic optics — Contact lenses — Determination of back vertex power — Part 1: Method
using focimeter with manual focusing.
ISO 9338:1996, Optics and optical instruments — Contact lenses — Determination of diameters.
ISO 9341:1996, Optics and optical instruments — Contact lenses — Determination of inclusions and surface
imperfections for rigid contact lenses.

1)  To be published (Revision of ISO 8320:1986).
2)  To be published.
1

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SIST EN ISO 11981:2000
© ISO
ISO 11981:1999(E)
ISO 10338:1996, Optics and optical instruments — Contact lenses — Determination of curvature.
ISO 10344:1996, Optics and optical instruments — Contact lenses — Saline solution for contact lens testing.
3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 8320-1 and ISO 8320-2 and
the following apply.
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
active control
contact lens that is cycled according to the test procedure using standard saline solution or appropriate justified
contact lens care product(s) instead of the contact lens care product under evaluation
NOTE Active controls are not required to comply with this International Standard, but may be used to gain further
information about the test.
4 Principle
4.1 Detection of changes in contact lens characteristics (see flow chart shown in Figure 1)
4.1.1  Before cycling, contact lenses shall be equilibrated in isotonic standard saline solution (ISO 10344) for at
least 15 min or for the time necessary to stabilize the contact lens parameters.
NOTE Equilibration times of up to 24 h may be required for some hydrogel lenses.
4.1.2  Contact lenses shall be cycled in a manner which simulates the procedures given in the manufacturer's
instructions for use of the product(s) to be tested.
4.1.3  Where a range of contact times is permitted, the cycle giving rise
...