BS EN ISO 9394:2012 BSl Standards Publication Ophthalmic optics Contact lenses and contact lens care products Determination of biocompatibility by ocular study with rabbit eyes bsi. ..making excellence a habit. BS EN ISO 9394:2012 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN ISO 9394:2012 It supersedes BS EN ISO 9394:1998, which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/172/9, Contact lenses and contact lens careproducts. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. @ The British Standards Institution 2012. Published by BSI Standards Limited 2012. ISBN9780580747946 ICS 11.040.70 Compliance witha British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2012. Amendments issuedsincepublication Date Text affected EUROPEANSTANDARD ENISO9394 NORMEEUROPEENNE EUROPAISCHENORM October 2012 ICS11.040.70 Supersedes EN ISO 9394:1998 English Version Ophthalmicoptics-Contactlenses andcontactlens 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 - Determination de la Bestimmung der Biokompatibilitat durch Erprobung am biocompatibilite par evaluation de la tolerance oculaire chez Kaninchenauge (ISO 9394:2012) le lapin (ISO 9394:2012) This European Standardwas approved by CEN on 30 September2012. 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 concerming 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. cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEEFOR NORMUNG Management Centre:Avenue Marnix 17,B-1000 Brussels @2012CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9394:2012: E worldwide for CEN national Members. ENISO9394:2012 (E) BS ENISO9394:2012 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. 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 ThisdocumentsupersedesENISO9394:1998 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 Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, N