M00000857
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ISO/ASTM 51702 3rd Edition, April 15, 2013 Practice for dosimetry in a gamma facility for radiation processing
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Availability date: 07/13/2021
Description / Abstract:
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.
For the radiation sterilization of health care products, see ISO
11137-1. In those areas covered by ISO 11137-1, 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 ASTM Practice E2628.
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.