1.1 This practice outlines the installation qualification program for an irradiator and
the dosimetric procedures to be followed during operational qualification, performance
qualification, and routine processing in facilities that process products with ionizing
radiation from radionuclide gamma sources to ensure that product has been treated
within a predetermined range of absorbed dose. Other procedures related to operational
qualification, performance qualification, and routine processing that may influence
absorbed dose in the product are also discussed.
NOTE 1 Dosimetry is only one component of a total quality assurance program for adherence
to good manufacturing practices used in radiation processing applications.
NOTE 2 ISO/ASTM Practices 51818 and 51649 describe dosimetric procedures for low and high
enery electron beam facilities for radiation processing and ISO/ASTM Practice 51608
describes procedures for X-ray (bremsstrahlung) facilities for radiation processing.