1.1 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 product 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.
1.2 Dosimetry is one component of a total quality assurance program for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.
1.3 For the irradiation of food and the radiation sterilization of health care products, other specific ISO standards exist. For food irradiation, see ISO 15554:1998, Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing (ASTM Practice E1204). For the radiation sterilization of health care products, see ISO 11137:1995, Sterilization of Health Care Products- Requirements for Validation and Routine Control- Radiation Sterilization. In those areas covered by ISO 11137, that standard takes precedence.
1.4 For guidance in the selection, calibration, and use of specific dosimeters, and interpretation of absorbed dose in the product from dosimetry measurements, see Guide E1261 and Practices E666, E668, E1026, E1205, E1275, E1276, E1310, E1400, E1401, E1538, E1540, E1607, and E1650. For discussion of radiation dosimetry for gamma rays, see ICRU Report 14.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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