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ILNAS-EN ISO 14534:2011 Edition 04/2011
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
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  • 21.2 / copy
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Abstract

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.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 170 : Ophthalmic optics

Directives

93/42/EEC : Medical devices
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

Implementation

start of the vote on the project    13/08/2009   date of ratification (dor)    31/03/2011
end of the vote on the project    13/01/2010   date of anouncement (doa)    31/07/2011
start of the vote on the final project    06/01/2011   date of publication (dop)    31/10/2011
end of the vote on the final project    06/03/2011   date of withdrawal (dow)    31/10/2011


Publication Official Journal
of the Grand-Duchy of Luxembourg
05/01/2012
Reference

Relations

Evolutions
ILNAS-EN ISO 14534:2015

Relations to older standards
ILNAS-EN ISO 14534:2009

Relations to international standards
ISO/NP 14534 
ISO 14534:2011 
ISO 14534:2011 

International Classification for Standards (ICS codes) :

11.040.70 : Ophthalmic equipment

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