1.1 This document provides guidance in determining
absorbed-dose distributions (mapping) in products, materials
or substances irradiated in gamma, X-ray (bremsstrahlung) and
electron beam facilities.
NOTE 1—For irradiation of food and the radiation sterilization of health
care products, specific ISO and ISO/ASTM standards containing dose
mapping requirements exist. See ISO/ASTM Practices 51431, 51608,
51649, 51702 and 51818 and ISO 11137-1. Regarding the radiation
sterilization of health care products, in those areas covered by ISO
11137-1, that standard takes precedence.
1.2 This guide is one of a set of standards that provides
recommendations for properly implementing dosimetry in
radiation processing. it is intended to be read in conjunction
with ISO/ASTM 52628.
1.3 Methods of analyzing the dose map data are described.
Examples are provided of statistical methods that may be used
to analyze dose map data.
1.4 Dose mapping for bulk flow processing and fluid
streams is not discussed.
1.5 Dosimetry is an element of a total quality management
system for an irradiation facility. Other controls besides dosimetry
may be required for specific applications such as
medical device sterilization and food preservation.
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 requirements prior to use.