1.1 This practice covers dosimetric procedures to be followed in facility characterization, process qualification, and routine processing using electron beam radiation to ensure that the entire product has been treated with an acceptable range of absorbed doses. Other procedures related to facility characterization (including equipment documentation), process qualification, and routine product processing that may influence and may be used to monitor absorbed dose in the product are also discussed.
Note 1—For guidance in the selection and calibration of dosimeters, see ISO/ASTM Guide 51261. For further guidance in the selection, calibration, and use of specific dosimeters, and interpretation of absorbed dose in the product from dosimetry, also see ASTM Practice E 668 and ISO/ASTM Practices 51275, 51276, 51431, 51607, 51631, and 51650. For use with electron energies above 5 MeV, see ASTM Practice E 1026, and ISO/ASTM Practices 51205, 51401, 51538, and 51540 for discussions of specific large volume dosimeters. For discussion of radiation dosimetry for pulsed radiation, see ICRU Report 34. When considering a dosimeter type, be cautious of influences from dose rates and accelerator pulse rates and widths (if applicable).
1.2 The electron energy range covered in this practice is between 300 keV and 25 MeV, although there are some discussions for other energies.
1.3 Dosimetry is only 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.
1.4 For the irradiation of food and the radiation sterilization of health care products, other specific ISO standards exist. For food irradiation, see ISO/ASTM Practice 51431. For the radiation sterilization of health care products, see ISO 11137. In those areas covered by ISO 11137, that standard takes precedence.
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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