1.1 This practice covers dosimetric procedures to be followed
in installation qualification, operational qualification and
performance qualification (IQ, OQ, PQ), and routine processing
at electron beam facilities to ensure that the product has
been treated with an acceptable range of absorbed doses. Other
procedures related to IQ, OQ, PQ, and routine product processing
that may influence absorbed dose in the product are
also discussed.
1.2 The electron beam energy range covered in this practice
is between 80 and 300 keV, generally referred to as low energy.
1.3 Dosimetry is only one component of a total quality
assurance program for an irradiation facility. Other measures
may be required for specific applications such as medical
device sterilization and food preservation.
1.4 Other specific ISO and ASTM standards exist for the
irradiation of food and the radiation sterilization of health care
products. For the radiation sterilization of health care products,
see ISO 11137. In those areas covered by ISO 11137, that
standard takes precedence. For food irradiation, see ISO
14470:2011. Information about effective or regulatory dose
limits for food products is not within the scope of this practice
(see ASTM F1355 and F1356).
1.5 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 E2232, “Practice for Dosimetry in
Radiation Processing”.
1.6 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.