EN ISO 9394:1998

Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study using rabbit eyes (ISO 9394:1998)

Specification of a procedure for the determination of biocompatibility of contact lenses by ocular studies with rabbit eyes.

Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Biokompatibilität durch Erprobung am Kaninchenauge (ISO 9394:1998)

Diese Internationale Norm legt ein in vivo - Prüfverfahren zur Bestimmung der Sicherheit von Kontaktlinsen und Kontaktlinsenpflegemitteln im Auge fest. Bei dieser Prüfung wird der Grad möglicher Reizungen, die vom zu erprobenden Medizinprodukt am Gewebe des Auges hervorgerufen werden, ermittelt. Das Prüfverfahren beschreibt die Anwendung auf Kaninchenaugen.

Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Détermination de la biocompatibilité par évaluation de la tolérance oculaire chez le lapin (ISO 9394:1998)

La présente Norme internationale décrit une méthode d'essai in vivo pour évaluer la tolérance oculaire des lentilles de contact et des produits d'entretien des lentilles de contact. L'essai permet d'évaluer le degré d'irritation des tissus oculaires provoqué par le dispositif soumis à l'essai. La méthode d'essai est décrite comme étant appliquée aux yeux du lapin.

Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Ugotavljanje biološke združljivosti z raziskavo na očeh kuncev (ISO 9394:1998)

General Information

• Status: Withdrawn
• Publication Date: 14-Aug-1998
• Withdrawal Date: 30-Sep-2012
• 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-Oct-2012
• Completion Date: 01-Oct-2012
• Ref Project: SIST EN ISO 9394:2000 - Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study using rabbit eyes (ISO 9394:1998)

Relations

• Replaced By: EN ISO 9394:2012 - Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
• Effective Date: 17-Oct-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9394:2000
01-januar-2000
2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHNRQWDNWQLKOHþ
8JRWDYOMDQMHELRORãNH]GUXåOMLYRVWL]UD]LVNDYRQDRþHKNXQFHY,62
Ophthalmic optics - Contact lenses and contact lens care products - Determination of
biocompatibility by ocular study using rabbit eyes (ISO 9394:1998)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der
Biokompatibilität durch Erprobung am Kaninchenauge (ISO 9394:1998)
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact
- Détermination de la biocompatibilité par évaluation de la tolérance oculaire chez le
lapin (ISO 9394:1998)
Ta slovenski standard je istoveten z: EN ISO 9394:1998
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 9394:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9394:2000

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SIST EN ISO 9394:2000

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SIST EN ISO 9394:2000

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SIST EN ISO 9394:2000

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SIST EN ISO 9394:2000

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SIST EN ISO 9394:2000
INTERNATIONAL ISO
STANDARD 9394
Second edition
1998-08-15
Ophthalmic optics — Contact lenses and
contact lens care products —
Determination of biocompatibility by ocular
study with rabbit eyes
Optique ophtalmique — Lentilles de contact et produits d’entretien pour
lentilles de contact — Détermination de la biocompatibilité par évaluation de
la tolérance oculaire chez le lapin
A
Reference number
ISO 9394:1998(E)

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SIST EN ISO 9394:2000
ISO 9394:1998(E)
Contents Page
1 Scope .1
2 Normative references .1
3 General requirements.1
4 Animals and husbandry .2
5 Reagents/Materials .2
6 Apparatus .3
7 Test specimens.3
8 Test procedure.3
9 Test report .5
10 Assessment of results.5
Annex A  McDonald-Shadduck score system — Slit lamp.6
Annex B  Draize scale for scoring ocular lesions .9
Annex C  Bibliography .11
©  ISO 1998
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 9394:2000
© ISO
ISO 9394:1998(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 r
...