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ASTM ASTM51261-26
Standard Practice for Calibration of Routine Dosimetry Systems for Radiation Processing
Standard Practice for Calibration of Routine Dosimetry Systems for Radiation Processing
E1261-26
ASTM|E1261-26|en-US
Standard Practice for Calibration of Routine Dosimetry Systems for Radiation Processing
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ASTM51261 Standard Practice for Calibration of Routine Dosimetry Systems for Radiation Processing>
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BOS Vol. 12.02 Committee E61
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Significance and Use
4.1 Standards such as ISO 11137-1 for radiation sterilization of healthcare products and ISO 14470 for irradiation of food state that dosimetry used in the process’s development, validation, and routine control adhere to specific requirements. These requirements state that the dosimetry must be traceable to national or international standards and have a known level of uncertainty.
4.1.1 This guide provides information on how to meet the requirements for dosimetry system calibration.
4.2 Ionizing radiation is used to produce various desired effects in products. Examples of applications include the sterilization of medical products and pharmaceuticals, microbial reduction, modification of polymers and electronic devices, and curing of inks, coatings, and adhesives (4).
4.3 Process parameters, together with their tolerances, are part of the process specification, and means of monitoring and controlling process variables shall be specified. A method for routinely monitoring the process, including the dose delivered, shall be specified.
4.4 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 Annex A4). The dosimetry system calibration is part of the user’s measurement management system.
Scope
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 (1-3)).
1.2 The absorbed-dose range covered is up to 1000 kGy.
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 requirements for implementing dosimetry in radiation processing and provides guidance for achieving compliance with the requirements of ISO 11137-1 (radiation sterilization of health care products), ISO 14470 (treatment of food), and ASTM 52628 (Standard Practice for Dosimetry in Radiation Processing). It relates to the evaluation and documentation of the dosimetry system calibration in conjunction with ASTM 52628 (Standard Practice for Dosimetry in Radiation Processing), and ASTM 51707 (Standard Guide for Estimation of Measurement Uncertainty in Dosimetry for Radiation Processing).
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.