International Organization for Standardization

Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV - Third Edition
 N ISO/ASTM 51608

Annotation

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.

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.

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.

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".