Scope
1.1 This practice covers dosimetric procedures to be followed in facility characterization, process qualification, and routine processing using X-rays (bremsstrahlung) to ensure that the entire product has been treated within an acceptable range of absorbed doses. Other procedures related to facility characterization, process qualification, and routine processing that may influence absorbed dose in the product are also discussed. The establishment of effective or regulatory dose and X-ray energy limits are not within the scope of this practice.
1.2 In contrast to monoenergetic gamma rays, the bremsstrahlung energy spectrum extends from low values up to the maximum energy of the electrons incident on the X-ray target (see Section 5 and the Appendix).
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 15562:1998, Practice for Dosimetry in Electron and Bremsstrahlung Irradiation Facilities for Food Processing (ASTM Practice E 1431). 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.
Note 1-For guidance in the selection, calibration, and use of specific dosimeters and interpretation of absorbed dose in the product from dose measurements, see the documents listed in 2.1, 2.2, and 2.3.
Note 2-Bremsstrahlung characteristics are similar to gamma rays from radioactive isotopes. See Practice E 1204 and E 1702 for the applications of dosimetry in the characterization and operation of gamma-ray irradiation facilities. For information concerning electron beam irradiation technology and dosimetry, see Practices E 1431and E 1649.
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.
