Preface:

This is the first edition of CSA ISO/TS 20914, Medical laboratories — Practice guidance for the estimation of measurement uncertainty, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 20914 (first edition, 2019-07).

This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.

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.