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)

ISO 9394:2012 specifies an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products. The test assesses the degree of irritation to the ocular tissue produced by the device under test. The test method is described in application to rabbit eyes.

Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Biokompatibilität durch Erprobung am Kaninchenauge (ISO 9394:2012)

Diese Internationale Norm legt ein in-vivo-Prüfverfahren zur Bestimmung der Sicherheit von neuartigen
Kontaktlinsenmaterialien 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 9394:2012)

L'ISO 9394:2012 décrit une méthode d'essai in vivo permettant d'évaluer la tolérance oculaire aux nouveaux matériaux constitutifs des lentilles de contact et aux produits d'entretien de ces lentilles. L'essai permet d'évaluer le degré d'irritation des tissus oculaires provoqué par le dispositif soumis à essai. La méthode d'essai décrite est expérimentée sur des yeux de lapin.

Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Ugotavljanje biološke združljivosti z raziskavo na očeh kuncev (ISO 9394:2012)

Ta mednarodni standard določa preskusno metodo in vivo za ocenjevanje očesne varnosti novih snovi za kontaktne leče in novih izdelkov za vzdrževanje kontaktnih leč. Preskus ocenjuje stopnjo vzdraženosti očesnega tkiva, ki jo povzroči preskusna naprava. Preskusna metoda je namenjena za uporabo na očeh kuncev.

General Information

• Status: Published
• Publication Date: 30-Sep-2012
• Withdrawal Date: 29-Apr-2013
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Oct-2012
• Completion Date: 01-Oct-2012
• Ref Project: SIST EN ISO 9394:2013 - Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)

Relations

• Replaces: 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)
• Effective Date: 17-Oct-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9394:2013
01-januar-2013
1DGRPHãþD
SIST EN ISO 9394:2000
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 with rabbit eyes (ISO 9394:2012)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der
Biokompatibilität durch Erprobung am Kaninchenauge (ISO 9394:2012)
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 9394:2012)
Ta slovenski standard je istoveten z: EN ISO 9394:2012
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 9394:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 9394:2013

---------------------- Page: 2 ----------------------

SIST EN ISO 9394:2013


EUROPEAN STANDARD
EN ISO 9394

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2012
ICS 11.040.70 Supersedes EN ISO 9394:1998
English Version
Ophthalmic optics - Contact lenses and contact lens care
products - Determination of biocompatibility by ocular study with
rabbit eyes (ISO 9394:2012)
Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel -
d'entretien pour lentilles de contact - Détermination de la Bestimmung der Biokompatibilität durch Erprobung am
biocompatibilité par évaluation de la tolérance oculaire chez Kaninchenauge (ISO 9394:2012)
le lapin (ISO 9394:2012)
This European Standard was approved by CEN on 30 September 2012.

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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9394:2012: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 9394:2013
EN ISO 9394:2012 (E)
Contents Page
Foreword .3
2

---------------------- Page: 4 ----------------------

SIST EN ISO 9394:2013
EN ISO 9394:2012 (E)
Foreword
This document (EN ISO 9394:2012) 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 April 2013, and conflicting national standards shall be withdrawn at the
latest by April 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9394:1998.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 9394:2012 has been approved by
...