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ILNAS-EN ISO 15004-2:2007 Edition 02/2007
Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2007)
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Abstract

ISO 15004-2:2007 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective International Standards. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye. ISO 15004-2:2007 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treatment of the eye. ISO 15004-2:2007 classifies ophthalmic instruments into either Group 1 or a Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 170 : Ophthalmic optics

Directives

93/42/EEC : Medical devices

Implementation

start of the vote on the project    12/01/2006   date of ratification (dor)    10/02/2007
end of the vote on the project    12/03/2006   date of anouncement (doa)    31/05/2007
start of the vote on the final project    09/11/2006   date of publication (dop)    31/08/2007
end of the vote on the final project    09/01/2007   date of withdrawal (dow)    31/08/2007


Publication Official Journal
of the Grand-Duchy of Luxembourg
23/04/2007
Reference

Relations

Evolutions
FprEN ISO 15004-2

Relations to older standards
ILNAS-EN ISO 15004:1997

Relations to international standards
ISO 15004-2:2007 
ISO 15004-2:2007 
ISO/AWI 15004-2 

International Classification for Standards (ICS codes) :

11.040.70 : Ophthalmic equipment

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