1.1 This practice outlines the dosimetric procedures to be followed during installation qualification, operational qualification, performance qualification and routine processing at an X-ray (bremsstrahlung) irradiator. Other procedures
related to operational qualification, performance qualification and routine processing that may influence absorbed dose in the product are also discussed.
NOTE 1—Dosimetry is only one component of a total quality assurance
program for adherence to good manufacturing practices used in radiation
processing applications.
NOTE 2—ISO/ASTM Practices 51649, 51818 and 51702 describe
dosimetric procedures for electron beam and gamma facilities for radiation
processing.
1.2 For radiation sterilization of health care products, see ISO 11137-1, Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. In those areas covered by ISO 11137-1, that standard takes precedence.
1.3 For irradiation of food, see ISO 14470, Food irradiation – Requirements for development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food. In those areas covered by ISO 14470,
that standard takes precedence.
1.4 This document is one of a set of standards that provides
recommendations for properly implementing and utilizing dosimetry in radiation processing. It is intended to be read in conjunction with ISO/ASTM Practice 52628, “Practice for Dosimetry in Radiation Processing”.
1.5 In contrast to monoenergetic gamma radiation, the X-ray 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 5 and Annex A1).
1.6 Information about effective or regulatory dose limits and energy limits for X-ray applications is not within the scope of this practice.
1.7 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.