9.9 Requirements for Dose Calibrators

Each radiopharmaceutical dosage must be assayed, to quantify its activity, in a calibrated dose calibrator prior to medical administration as required by regulation.

Dose calibrators used to measure the amount of activity administered to patients must be checked for constancy, accuracy, linearity, and geometry dependence according to regulatory requirements.  Additionally, these checks must be repeated following dose calibrator repair or adjustment prior to returning the unit to service.  The use of a dose calibrator for patient dosage assay that has not been tested, or has failed testing as required, is a violation of regulations.