ISO/TS 20914:2019Published

Medical laboratories — Practical guidance for the estimation of measurement uncertainty

Laboratoires de biologie médicale — Recommandations pratiques pour l’estimation de l’incertitude de mesure

Abstract / scope

This document provides practical guidance for the estimation and expression of the measurement uncertainty (MU) of quantitative measurand values produced by medical laboratories. Quantitative measurand values produced near the medical decision threshold by point-of-care testing systems are also included in this scope. This document also applies to the estimation of MU for results produced by qualitative (nominal) methods which include a measurement step. It is not recommended that estimates of MU be routinely reported with patient test results, but should be available on request.

NOTE See Annex B for an example of application of the MU.