DIN EN ISO 18153:2003-11

This European Standard specifies how to assure the traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes, and provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. This European Standard describes requirements for the selection and properties of enzyme calibration materials appropriate to their use as elements of a calibration hierarchy of measurement procedures and calibrators.