1.1 This practice outlines the installation qualification program
for an irradiator and the dosimetric procedures to be
followed during operational qualification, performance qualification,
and routine processing in facilities that process products
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 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 51818 and 51649 describe dosimetric
procedures for low and high enery electron beam facilities for radiation
processing and ISO/ASTM Practice 51608 describes procedures for X-ray
(bremsstrahlung) facilities for radiation processing.
1.2 For the radiation sterilization of health care products,
see ISO 11137-1. In those areas covered by ISO 11137-1, that
standard takes precedence.
1.3 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 ASTM Practice E2628.
1.4 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.