CLSI X5-R

Metrological Traceability and Its Implementation; A Report

Clinical and Laboratory Standards Institute document X5-R-Metrological Traceability and Its Implementation; A Report provides guidance on establishing traceability of the chemical calibration step in clinical laboratory measurements, based on the traceability requirements for in vitro diagnostic (IVD) medical devices as given in ISO 175111 and ISO 15183,2 and in accordance with the requirements for traceability as stated in the IVD Directive [i.e., Directive of the European Parliament on In Vitro Diagnostic Medical Devices (Directive 98/79/EC)3]. Though this report is aimed principally at manufacturers of IVD medical devices, the concepts and approaches recommended may be extended to apply to routine analysis conducted in the clinical laboratory either with commercially available or "home-brew" IVDs.