|ASTM/ISO 51261-13(2020) - 1.10.2020|
|Significance and Use|
4.1 Ionizing radiation is used to produce various desired effects in products. Examples of applications include the sterilization of medical products, microbial reduction, modification of polymers and electronic devices, and curing of inks, coatings, and adhesives (. )
4.2 Absorbed-dose measurements, with statistical controls and documentation, are necessary to ensure that products receive the desired absorbed dose. These controls include a program that addresses requirements for calibration of routine dosimetry system.
4.3 A routine dosimetry system calibration procedure as described in this document provides the user with a dosimetry system whose dose measurements are traceable to national or international standards for the conditions of use (see ). The dosimetry system calibration is part of the user’s measurement management system.
1.1 This practice specifies the requirements for calibrating routine dosimetry systems for use in radiation processing, including establishing measurement traceability and estimating uncertainty in the measured dose using the calibrated dosimetry system.
Note 1: Regulations or other directives exist in many countries that govern certain radiation processing applications such as sterilization of healthcare products and radiation processing of food requiring that absorbed-dose measurements be traceable to national or international standards (ISO 11137-1, Refs ()).
1.2 The absorbed-dose range covered is up to 1 MGy.
1.3 The radiation types covered are photons and electrons with energies from 80 keV to 25 MeV.
1.4 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ASTM “Practice for Dosimetry in Radiation Processing” for the calibration of routine dosimetry systems. It is intended to be read in conjunction with ASTM and the relevant ASTM or ISO/ASTM standard practice for the dosimetry system being calibrated referenced in Section .
1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.