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ILNAS-EN ISO 15004:1997 Edition 12/1997
Ophthalmic instruments - Fundamental requirements and test methods (ISO 15004:1997)
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Abstract

This International Standard specifies Fundamental requirements for non-invasive, active and non-active ophthalmic instruments. This International Standard 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 eyes. This International Standard takes precedence over the corresponding requirements of the other general standards cited in clause 2, if differences exist. This International Standard does not apply 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Standard - Superseded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

Implementation

start of the vote on the project    07/12/1995   date of ratification (dor)    04/12/1997
end of the vote on the project    07/05/1996   date of anouncement (doa)    31/03/1998
start of the vote on the final project    21/08/1997   date of publication (dop)    30/06/1998
end of the vote on the final project      date of withdrawal (dow)    30/06/1998


Publication Official Journal
of the Grand-Duchy of Luxembourg
30/01/1998
Reference

Relations

Evolutions
ILNAS-EN ISO 15004-2:2007
ILNAS-EN ISO 15004-1:2006

Relations to international standards
ISO/CD 15004 
ISO 15004:1997 

International Classification for Standards (ICS codes) :

11.040.70 : Ophthalmic equipment

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