IEC 63465 ED1

Calibration and quality control in the use of radionuclide calibrators

Scope

IEC 63465:2025 specifies the techniques for calibration and usage of pressurised, well-type ionisation chambers for activity measurements of radioactive sources. Such instruments are used to determine the activity, expressed in becquerel (Bq), of photon and some medium to high-energy beta-emitters.
This document addresses calibration procedures of ionisation chambers and radionuclide calibrators to be used by equipment manufacturers, national metrology institutes and designated institutes, radionuclide producers, suppliers, distributors, and end users, like nuclear medicine facilities, industrial or hospital (radio)pharmacies, research laboratories, and nuclear power plants.
This document provides the methods and tests for establishing conformity of device acceptability and maintaining acceptable instrument performance. Performance benchmarks vary depending on the application, so information is given specific to field class instruments for end users and reference class instruments for standards laboratories and instrument manufacturers.
The ionisation chamber or radionuclide calibrator can be an instrument that is used as a standalone device, but it can also be integrated in a much larger appliance, such as a laminar air flow cabinet, a fume hood, a hot cell, or a dispensing unit. The instrument can also be equipped with accessories that are essential for the intended use of the appliance that surrounds and incorporates the radionuclide calibrator. The proper use of each of the accessories can be important for the correct use of the radionuclide calibrator and therefore is part of the scope of this document.
The software and computer system(s) that can be used to control the radionuclide calibrator hardware and functioning are considered an integral part of the device and therefore are also considered part of the scope of this document.
IEC 63465:2025 cancels and replaces IEC TR 61948-4:2019, IEC 61303:1994, IEC 61145:1992. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to IEC TR 61948 4:2019, IEC 61303:1994 and IEC 61145:1992:
a) technical specifications and quality control procedures are updated to apply to modern instruments;
b) test acceptance criteria are defined for reference class and field class devices;
c) recommendations are given on recording and logging of test data, including the use of control charts;
d) specific calibration guidance is included, including guidance for subsidiary calibrations with end-user-defined source geometries.