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ILNAS-EN ISO 15004-1:2020 Edition 11/2020
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)
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Abstract

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

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 170 : Ophthalmic optics

Implementation

start of the vote on the project    06/06/2019   date of ratification (dor)    05/09/2020
end of the vote on the project    30/08/2019   date of anouncement (doa)    28/02/2021
start of the vote on the final project    06/08/2020   date of publication (dop)    31/05/2021
end of the vote on the final project    01/10/2020   date of withdrawal (dow)    31/05/2021


Publication Official Journal
of the Grand-Duchy of Luxembourg
25/05/2021
Reference Mémorial A N° 393

Relations

Relations to older standards
ILNAS-EN ISO 15004-1:2009

Relations to international standards
ISO 15004-1 
ISO 15004-1:2020 

International Classification for Standards (ICS codes) :

11.040.70 : Ophthalmic equipment

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