The main contents determined include the terms and definitions for assigning values to in vitro diagnostic calibrators (working calibrators and product calibrators), overall requirements (compliance with principles, traceability endpoint selection and determination of target uncertainty, selection of measurement procedures, traceability diagrams and calibration plans , Confirm the analytical performance of measurement procedures at all levels, interchangeability studies, quality control, assess measurement uncertainty, traceability confirmation), assignment scheme (overview, reference measurement procedure assignment, reference material assignment, methodological comparison assignment)
T/ZMDS 40001-2021 history
2021T/ZMDS 40001-2021 Guidelines for values assignment of calibrator of IVD