In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials Ingestion-build-83346 together with all associated structures

together with all associated structures

It can also be used in conjunction with other standards for specific clinical specialities

distributed

Contents of DD IEC/TS 61850-80-1:

In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials Ingestion-build-83346 together with all associated structuresBS EN ISO 18153: 2003 specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. The following subjects are outside the scope of this standard: a)