EN ISO 11979-4:2008

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008)

ISO 11979-4:2008 specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.

Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information (ISO 11979-4:2008)

Dieser Teil von ISO 11979 legt Anforderungen an die Etikettierung von Intraokularlinsen (IOLs) und die in oder auf deren Verpackung anzugebenden Informationen fest.
ANMERKUNG   Dieser Teil von ISO 11979 versucht, die weltweit bestehenden Anforderungen an die Etikettierung von Intraokularlinsen zu harmonisieren. Nationale Anforderungen können jedoch zusätzliche Regelungen beinhalten.

Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Étiquetage et informations (ISO 11979-4:2008)

L'ISO 11979-4:2008 spécifie les exigences relatives à l'étiquetage des lentilles intraoculaires (LIO), ainsi que les informations à fournir dans leur emballage ou sur celui-ci.

Očesni vsadki (implantati) - Intraokularne leče - 4. del: Označevanje in informacije (ISO 11979-4:2008)

Ta del standarda ISO 11979 določa zahteve za označevanje intraokularnih leč (IOL) in informacije, ki morajo biti priložene embalaži ali biti natisnjene na embalaži.

General Information

• Status: Published
• Publication Date: 30-Nov-2008
• Withdrawal Date: 29-Jun-2009
• 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-Dec-2008
• Completion Date: 01-Dec-2008
• Ref Project: SIST EN ISO 11979-4:2009 - Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008)

Relations

• Replaces: EN ISO 11979-4:2000 - Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2000)
• Effective Date: 22-Dec-2008
• Amended By: EN ISO 11979-4:2008/A1:2012 - Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information - Amendment 1 (ISO 11979-4:2008/Amd 1:2012)
• Effective Date: 06-Mar-2010

Standards Content (Sample)

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



SIST EN ISO 11979-4:2009



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



EN ISO 11979-4:2008 (E) 2 Contents Page Foreword .3 SIST EN ISO 11979-4:2009



EN ISO 11979-4:2008 (E) 3 Foreword This document (EN ISO 11979-4:2008) has been prepared by Technical Committee ISO/TC 172 "Optics and optical instruments" 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 June 2009, and conflicting national standards shall be withdrawn at the latest by June 2009. 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 11979-4:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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 the United Kingdom. Endorsement notice The text of ISO 11979-4:2008 has been approved by CEN as a EN ISO 11979-4:2008 without any modification.
SIST EN ISO 11979-4:2009



SIST 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
SIST EN ISO 11979-4:2009



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