ISO 15193:2026

In vitro diagnostic medical devices — Requirements for reference measurement procedures

This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine.

This document applies to:

1. RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;
2. any person, body or institution developing RMPs for measurands used in laboratory medicine.