DIN 58964:2014-10

This Standard is directed to manufacturers and users. It describes procedures for the evaluation of comparative measurements, which take into account the special situation of simultanious application of POCT procedures and methods in the central laboratory. This Standard defines measures for analytical and clinical evaluation of a measurand in case of the application of different diagnostic procedures (POCT among themselfes and non-POCT) in the medical-diagnostic field. These measures have to secure the concondance of results determined in different sample types. In context of this Standard, specimens are native-blood or anticoagulated whole blood, urine and other body fluids of patients treaten in the facility. The use of POCT is carried out as part of the medical activities, but also outside of the medical science. This Standard applies for POCT within the medical science only; POCT for self-administartion is not covered.