The proposed deliverable should be a European standard.
The proposed EN Standard can be used by manufacturers and users.
This Standard specifies requirements and concepts for the analytical and clinical assessment of measurement results when using different diagnostic methods (both POCT and non-POCT) for in vitro diagnostic testing. The requirements laid down in the Standard ensure that results obtained in various sample materials and by using different methods are concordant. Samples within the meaning of this Standard are native blood or anti-coagulated blood, urine and other body fluids of patients treated in the health facility. The principles of the proposed Standard should only apply for POCT within the context of medical in vitro diagnostic testing and for POCT in self-testing.
Registration number (WIID)
62240
Scope
The proposed deliverable should be a European standard.
The proposed EN Standard can be used by manufacturers and users.
This Standard specifies requirements and concepts for the analytical and clinical assessment of measurement results when using different diagnostic methods (both POCT and non-POCT) for in vitro diagnostic testing. The requirements laid down in the Standard ensure that results obtained in various sample materials and by using different methods are concordant. Samples within the meaning of this Standard are native blood or anti-coagulated blood, urine and other body fluids of patients treated in the health facility. The principles of the proposed Standard should only apply for POCT within the context of medical in vitro diagnostic testing and for POCT in self-testing.
