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ILNAS-EN ISO 11979-8:2009 Edition 04/2009
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)
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  • 17.2 / copy
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Abstract

11979-8:2006 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.

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      date of ratification (dor)    07/03/2009
end of the vote on the project      date of anouncement (doa)    31/07/2009
start of the vote on the final project    06/11/2008   date of publication (dop)    31/10/2009
end of the vote on the final project    06/02/2009   date of withdrawal (dow)    21/03/2010


Publication Official Journal
of the Grand-Duchy of Luxembourg
14/03/2012
Reference

Relations

Evolutions
ILNAS-EN ISO 11979-8:2015
ILNAS-EN ISO 11979-8:2009/A1:2011

Relations to older standards
ILNAS-EN ISO 11979-8:2006

International Classification for Standards (ICS codes) :

11.040.70 : Ophthalmic equipment

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