limitation of the procedure

specific situation in which an IVD examination procedure might not perform as intended

Note 1

Factors that affect the performance of an IVD examination procedure can be physiological as well as analytical.

Note 2

Adapted from Reference [48].

Norm

Titel

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

Paragraaf

3.35