performance claim

specification of a performance characteristic of an IVD medical device as documented in the information supplied by the manufacturer

Note 1

This can be based upon prospective performance studies, available performance data or studies published in the scientific literature.

Note 2

Adapted from EN 13612:2002, definition 2.7.

Norm

Titel

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Paragraaf

3.51