EN ISO 11979-4:2008

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information (ISO 11979-4:2008)Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Étiquetage et informations (ISO 11979-4:2008)Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 11979-4:2008SIST EN ISO 11979-4:2009en01-marec-2009SIST EN ISO 11979-4:2009SLOVENSKI
STANDARDSIST EN ISO 11979-4:20001DGRPHãþD

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 11979-4December 2008ICS 11.040.70Supersedes EN ISO 11979-4:2000
English VersionOphthalmic implants - Intraocular lenses - Part 4: Labelling andinformation (ISO 11979-4:2008)Implants ophtalmiques - Lentilles intraoculaires - Partie 4:Étiquetage et informations (ISO 11979-4:2008)Ophthalmische Implantate - Intraokularlinsen - Teil 4:Etikettierung und Information (ISO 11979-4:2008)This European Standard was approved by CEN on 29 November 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11979-4:2008: ESIST EN ISO 11979-4:2009

Reference numberISO 11979-4:2008(E)© ISO 2008
INTERNATIONAL STANDARD ISO11979-4Second edition2008-12-01Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information Implants ophtalmiques — Lentilles intraoculaires — Partie 4: Étiquetage et informations
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ii © ISO 2008 – All rights reserved
ISO 11979-4:2008(E) © ISO 2008 – All rights reserved iiiForeword 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 2. The main task of technical committees is to prepare International Standards. 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. 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. ISO 11979-4 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 11979-4:2000), which has been technically revised. ISO 11979 consists of the following parts, under the general title Ophthalmic implants — Intraocular lenses: ⎯ Part 1: Vocabulary ⎯ Part 2: Optical properties and test methods ⎯ Part 3: Mechanical properties and test methods ⎯ Part 4: Labelling and information ⎯ Part 5: Biocompatibility ⎯ Part 6: Shelf-life and transport stability ⎯ Part 7: Clinical investigations ⎯ Part 8: Fundamental requirements ⎯ Part 9: Multifocal intraocular lenses ⎯ Part 10: Phakic intraocular lenses SIST EN ISO 11979-4:2009

ISO 11979-4:2008(E) iv © ISO 2008 – All rights reserved Introduction This part of ISO 11979 contains requirements and guidance for the labelling of intraocular lens
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