1 This practice outlines the installation qualification pro-gram for an irradiator and the dosimetric procedures to be followed during operational qualification, performance quali-fication, and routine processing in facilities that process prod-uct with ionizing radiation from radionuclide gamma sources to ensure that product has been treated within a predetermined range of absorbed dose. Other procedures related to installation qualification, operational qualification, performance qualifica-tion, and routine processing that may influence absorbed dose in the product are also discussed. Information about effective or regulatory absorbed-dose limits is not within the scope of this practice.
Note 1—Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices.
Note 2—ISO/ASTM Practices 51649 and 51608 describe dosimetric procedures for electron beam and X-ray (bremsstrahlung) irradiation facilities for radiation processing.
2 For the irradiation of food and the radiation sterilization of health care products, other specific ISO/ASTM or ISO standards exist. For food irradiation, see ISO/ASTM Practice 51204. For the radiation sterilization of health care products, see ISO 11137. In those areas covered by ISO/ASTM Practice 51204 or ISO 11137, those standards take precedence.
3 For guidance in the selection and calibration of dosim-etry systems, and interpretation of measured absorbed dose in the product, see ISO/ASTM Guide 51261 and ASTM Practice E 666. For the use of specific dosimetry systems, see ASTM Practices E 1026 and E 2304, and ISO/ASTM Practices 51205. 51275. 51276, 51310, 51401, 51538, 51540, 51607, 51650, and 51956. For discussion of radiation dosimetry for gamma-rays and X-rays also see ICRU Report 14.
4 Tliis 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 appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.