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ILNAS-EN ISO 18113-4:2011 Edition 10/2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
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Abstract

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing. ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. ISO 18113-4:2009 can also be applied to accessories, where appropriate. ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

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      date of ratification (dor)    20/09/2011
end of the vote on the project      date of anouncement (doa)    31/01/2012
start of the vote on the final project      date of publication (dop)    30/04/2012
end of the vote on the final project      date of withdrawal (dow)    31/10/2014


Publication Official Journal
of the Grand-Duchy of Luxembourg
05/06/2013
Reference Mémorial A N° 92

Relations

Evolutions
FprEN ISO 18113-4

Relations to older standards
ILNAS-EN ISO 18113-4:2009

International Classification for Standards (ICS codes) :

11.100.10 : In vitro diagnostic test systems

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