verification of calibration

confirmation that stated trueness claims for an IVD measuring system are achieved

Note 1

Calibration verification requires reference materials with assigned values at concentrations appropriate for the intended use.

Note 2

Calibration verification is sometimes confused with calibration (3.9), linearity verification or routine control procedures.

Norm

Titel

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

Paragraaf

3.10