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ILNAS-EN 13532:2002 Edition 04/2002
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Abstract

This standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer. This standard does not address medical aspects of IVD MDs for self-testing.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 140 : In vitro diagnostic medical devices

Directives

98/79/EC : In vitro diagnostic medical devices

Implementation

start of the vote on the project    06/05/1999   date of ratification (dor)    27/12/2001
end of the vote on the project    06/11/1999   date of anouncement (doa)    31/07/2002
start of the vote on the final project    13/09/2001   date of publication (dop)    31/10/2002
end of the vote on the final project    13/11/2001   date of withdrawal (dow)    31/10/2002


Publication Official Journal
of the Grand-Duchy of Luxembourg
27/08/2002
Reference

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Evolutions

International Classification for Standards (ICS codes) :

11.100 : Laboratory medicine

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