intended use

objective intent of an IVD manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information supplied by the IVD manufacturer

Note 1

Intended use statements for IVD labelling can include two components: a description of the functionality of the IVD medical device (e.g., an immunochemical measurement procedure for the detection of analyte “x” in serum or plasma), and a statement of the intended medical use of the examination results.

Note 2

This is the definition adopted by the GHTF in Reference [36].

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

3.31

intended use

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