
Standard Document
First Edition
ISO
ISO21151
In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
This document establishes requirements for an international harmonization protocol to achieve equivalent results across multiple in vitro diagnostic medical devices (IVD MDs) for the same measurand when no reference measurement procedures or certified reference materials exist. It defines the highest level of metrological traceability and can also be applied when existing reference materials or calibrators are not fit-for-purpose, such as when they lack commutability with human samples.
NOTE This document addresses one case of traceability of assigned and measured values described in 5.6 in ISO 17511:2020.
May 01, 2020
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ISO21151
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