Metrological Traceability of Values Assigned to Sysmex SCS-1000 Haematology Calibrator

• Metrological Traceability of Values Assigned to Sysmex SCS-1000 Haematology Calibrator

AUTHOR(S)

Matthias KUTZNER

Sysmex Europe GmbH

SUMMARY

This article describes the traceability chains of values assigned to the Sysmex SCS-1000 haematology calibrator which are required by ANNEX I A 3 of the in vitro diagnostic
( IVD ) Directive and defined in the subclauses of the new standard prEN ISO 17511 currently in preparation and at the Committee Draft stage.

KEY WORDS

In vitro Diagnostic ( IVD ) Medical Device Directive, Metrological Traceability, Uncertainty of Measurement, Calibrator