1.1 This practice covers dosimetric procedures to be followed infacility characterization, process qualification, and routineprocessing using X rays (bremsstrahlung) to ensure that the entireproduct has been treated within an acceptable range of absorbeddoses. Other procedures related to facility characterization,process qualification, and routine processing that may influenceabsorbed dose in the product are also discussed. The establishmentof effective or regulatory dose and X-ray energy limits are notwithin the scope of this practice.

1.2 In contrast to monoenergetic gamma rays, the bremsstrahlungenergy spectrum extends from low values up to the maximum energy ofthe electrons incident on the X-ray target (see Section 5 and AnnexA1).

1.3 Dosimetry is only one component of a total quality assuranceprogram for an irradiation facility. Other controls besidesdosimetry may be required for specific applications such as medicaldevice sterilization and food preservation.

1.4 For the irradiation of food and the radiation sterilizationof health care products, other specific ISO standards exist. Forfood irradiation, see ISO/ASTM Practice 51431. For the radiationsterilization of health care products, see ISO 11137:1995. In thoseareas covered by ISO 11137, that standard takes precedence.

Note 1—For guidance in the selection, calibration, and use ofspecific dosimeters and interpretation of absorbed dose in theproduct from dose measurements, see the documents listed in 2.1,2.3 and 2.4.

Note 2—Bremsstrahlung characteristics are similar to gamma raysfrom radioactive isotopes. See ISO/ASTM Practices 51204 and 51702for the applications of dosimetry in the characterization andoperation of gamma-ray irradiation facilities. For informationconcerning electron beam irradiation technology and dosimetry, seeISO/ASTM Practices 51431 and 51649.

1.5 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establishappropriate safety and health practices and determine theapplicability of regulatory limitations prior to use.