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ILNAS-EN ISO 15004-1:2009 Edition 04/2009
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)
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Abstract

ISO 15004-1:2006 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. ISO 15004-1:2006 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye. ISO 15004-1:2006 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

Status

Standard - Superseded

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
14/03/2011
Reference Mémorial A N° 47

Relations

Evolutions
ILNAS-EN ISO 15004-1:2020

Relations to older standards
ILNAS-EN ISO 15004-1:2006

International Classification for Standards (ICS codes) :

11.040.70 : Ophthalmic equipment

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