EN ISO 14534:2009

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)

This International Standard specifies safety and performance requirements for contact lenses, contact lens care products and other accessories for contact lenses.
This International Standard does not specify electrical safety and electromagnetic compatibility considerations that might arise from the use of electrical equipment in conjunction with contact lenses and/or contact lens care products.

Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen (ISO 14534:2002)

Diese Internationale Norm legt Anforderungen an die Sicherheit und Funktion von Kontaktlinsen, Kontaktlinsenpflegemitteln
und anderem Zubehör für Kontaktlinsen fest.
Diese Internationale Norm legt keine Anforderungen zur elektrischen Sicherheit und zur elektromagnetischen
Verträglichkeit fest, die sich möglicherweise durch den Gebrauch von elektrischen Geräten in Verbindung mit
Kontaktlinsen und/oder Kontaktlinsenpflegemitteln ergeben können.

Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Exigences fondamentales (ISO 14534:2002)

Basic template for the development of ISO and ISO/IEC standards

Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Temeljne zahteve (ISO 14534:2002)

General Information

• Status: Withdrawn
• Publication Date: 24-Mar-2009
• Withdrawal Date: 31-Mar-2011
• 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-Apr-2011
• Completion Date: 01-Apr-2011
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 14534:2009 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)

Relations

• Replaces: EN ISO 14534:2002 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 14534:2011 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
• Effective Date: 09-Apr-2011

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen (ISO 14534:2002)Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Exigences fondamentales (ISO 14534:2002)Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 14534:2009SIST EN ISO 14534:2009en01-maj-2009SIST EN ISO 14534:2009SLOVENSKI
STANDARDSIST EN ISO 14534:20021DGRPHãþD



SIST EN ISO 14534:2009



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 14534March 2009ICS 11.040.70Supersedes EN ISO 14534:2002
English VersionOphthalmic optics - Contact lenses and contact lens careproducts - Fundamental requirements (ISO 14534:2002)Optique ophtalmique - Lentilles de contact et produitsd'entretien des lentilles de contact - Exigencesfondamentales (ISO 14534:2002)Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel -Grundlegende Anforderungen (ISO 14534:2002)This European Standard was approved by CEN on 7 March 2009.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:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14534:2009: ESIST EN ISO 14534:2009



EN ISO 14534:2009 (E) 2 Contents Page Foreword .3 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .4
SIST EN ISO 14534:2009



EN ISO 14534:2009 (E) 3 Foreword The text of ISO 14534:2002 has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 14534:2009 by 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 September 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. 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 14534:2002. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC, as amended by Directive 2007/47/EC. For relationship with EU Directive 93/42/EEC as amended by Directive 2007/47/EC, see informative Annex ZA, which is an integral part of this document. 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 14534:2002 has been approved by CEN as a EN ISO 14534:2009 without any modification. SIST EN ISO 14534:2009



EN ISO 14534:2009 (E) 4 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared un
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