Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing
1.1 This practice outlines the installation qualification program for an X-ray (bremsstrahlung) irradiator and the dosimetric procedures to be followed during operational qualification, performance qualification and routine processing to ensure that the entire 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. Information about effective or regulatory dose limits and energy limits for X-radiation is not within the scope of this practice.
1.2 In contrast to monoenergetic gamma radiation, the bremsstrahlung energy spectrum extends from low values (about 35 keV) up to the maximum energy of the electrons incident on the X-ray target (see Section and ).
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 StandardDetails 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/ASTM Practice 51431 or ISO 11137, those StandardDetails take precedence.
Note 1For 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 Section.
Note 2Bremsstrahlung characteristics are similar to those of gamma radiation from radioactive nuclides. See ISO/ASTM Practices 51204 and 51702 for the applications of dosimetry in the characterization and operation of gamma irradiation facilities. For information concerning electron beam irradiation technology and dosimetry, see ISO/ASTM Practices 51431 and 51649.
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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