Performance criteria for reference measurement procedures and reference materials.

The concept of metrological traceability of measurement results to property values assigned to measurement standards of higher metrological order or to the International System of Units (SI) through sequential calibrations, using reference materials and reference measurement procedures, plays a key role in ensuring that end user measurement procedures perform at an acceptable level in the clinical context. The aim is that measurement results produced over time or by different end users or with different end user measurement procedures for the same measurand will be equivalent within their corresponding uncertainties. These goals can only be reached under certain conditions and if requirements laid down in international standards on calibration concepts, reference measurement procedures and reference materials are fulfilled. Calibration hierarchies have to be implemented correctly and parameters contributing to measurement uncertainty and systematic bias need to be controlled and eliminated, respectively, by technically improving methods and reference materials and intermediate calibrators used for effectively achieving equivalence of measurement results and for meeting analytical performance requirements for in vitro diagnostic devices.