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in vitro diagnostic medical device

device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles

Note 1

This is the definition adopted by the GHTF in [47].

Norm
NEN-EN-ISO 18113-1:2011 en
Titel
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
Paragraaf
3.27
Terug

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