Clinical laboratories shall have a perfect control of "in vitro diagnostic medical devices" to ensure the quality of their analytical results. This introductory presentation to a serie of documents of recommendations tackles the different standards of metrology concerning the requirements to reference materials, metrological traceability, metrological confirmation, management of measurement as well as uncertainty of measurement. The standards concerning clinical laboratories are then succinctly described.
Copyright John Libbey Eurotext 20003.