EN ISO 14534:2011

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)

ISO 14534:2011 specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses.
ISO 14534:2011 does not specify electrical safety and electromagnetic compatibility considerations that might arise from the use of electrical equipment in conjunction with contact lenses or contact lens care products.

Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen (ISO 14534:2011)

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 oder Kontaktlinsenpflegemitteln ergeben können.

Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Exigences fondamentales (ISO 14534:2011)

L'ISO 14534:2011 spécifie les exigences de sécurité et de performance s'appliquant aux lentilles de contact, produits d'entretien des lentilles de contact et autres accessoires utilisés avec les lentilles de contact.
L'ISO 14534:2011 ne traite pas de sécurité électrique ni de considérations de compatibilité électromagnétique potentiellement liées à l'utilisation d'équipements électriques avec les lentilles de contact et/ou les produits d'entretien pour lentilles de contact.

Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Temeljne zahteve (ISO 14534:2011)

Ta mednarodni standard določa varnostne in delovne zahteve za kontaktne leče, izdelke za vzdrževanje kontaktnih leč in drugih pripomočkov za kontaktne leče. Ta mednarodni standard ne določa električne varnosti in vidike elektromagnetne združljivosti, ki se lahko pojavijo z uporabo električne opreme skupaj s kontaktnimi lečami ali izdelki za vzdrževanje kontaktnih leč.

General Information

• Status: Withdrawn
• Publication Date: 31-Mar-2011
• Withdrawal Date: 27-Jan-2015
• 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
• Completion Date: 28-Jan-2015
• 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 14534:2011 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)

Relations

• Replaces: EN ISO 14534:2009 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)
• Effective Date: 09-Apr-2011
• Replaced By: EN ISO 14534:2015 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
• Effective Date: 04-Feb-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14534:2011
01-julij-2011
1DGRPHãþD
SIST EN ISO 14534:2009
2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHNRQWDNWQLKOHþ7HPHOMQH
]DKWHYH,62
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental
requirements (ISO 14534:2011)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen
(ISO 14534:2011)
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact
- Exigences fondamentales (ISO 14534:2011)
Ta slovenski standard je istoveten z: EN ISO 14534:2011
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 14534:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14534:2011

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SIST EN ISO 14534:2011


EUROPEAN STANDARD
EN ISO 14534

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2011
ICS 11.040.70 Supersedes EN ISO 14534:2009
English Version
Ophthalmic optics - Contact lenses and contact lens care
products - Fundamental requirements (ISO 14534:2011)
Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel -
d'entretien des lentilles de contact - Exigences Grundlegende Anforderungen (ISO 14534:2011)
fondamentales (ISO 14534:2011)
This European Standard was approved by CEN on 31 March 2011.

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, 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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14534:2011: E
worldwide for CEN national Members.

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SIST EN ISO 14534:2011
EN ISO 14534:2011 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EC Directive 93/42/EEC .4

2

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SIST EN ISO 14534:2011
EN ISO 14534:2011 (E)
Foreword
This document (EN ISO 14534:2011) 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 October 2011, and conflicting national standards shall be withdrawn at
the latest by October 2011.
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 14534:2009.
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(s).
For relationship with EU Directive(s), 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, Croatia, 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, Switz
...