Practice for dosimetry in a gamma irradiation facility for radiation processing. 1. ed.

This practice outlines dosimetric procedures to be followed in irradiator characterization, process qualification and routine processing in a gamma irradiation facility. These procedures ensure that all products processed with ionizing radiation from isotopic gamma sources receive absorbed doses within a predetermined range. Other procedures related to irradiator characterization, process qualification and routine processing that may influence absorbed dose in the product are also discussed. Information about effective or regulatory dose limits is not within the scope of this document. This practice describes general procedures applicable to all gamma radiation processing requiring absorbed doses within a predetermined range. For procedures specific to food irradiation, see Practice E 1204. The sterilization of medical devices is a regulated irradiation process with specific process control requirements. These requirements, including specific dosimetry requirements for medical device sterilization, are given in this practice. Guidelines for medical device sterilization are also given. For guidance in the selection, calibration and use of specific dosimeters and interpretation of absorbed dose in the product from dosimetry requirements, see Guide E 1261 and Practices E 666, E 668, E 1026, E 1205, E 1275, E 1276, E 1310, E 1400, E 1401, E 1538, E 1540, E 1607 and E 1650. For discussion of radiation dosimetry for gamma rays, see ICRU Report 14