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Standard Guide for Estimation of Measurement Uncertainty in Dosimetry for Radiation Processing
1.1 This standard provides guidance on the use of concepts described in the JCGM (Joint Committee for Guides in Metrology) Evaluation of Measurement Data – Guide to the Expression of Uncertainty in Measurement (GUM) to estimate the uncertainties in the measurement of absorbed dose in radiation processing.
1.2 Methods are given for identifying, evaluating, and estimating the components of measurement uncertainty associated with the use of dosimetry systems, and for calculating combined standard measurement uncertainty and expanded uncertainty of dose measurements based on the GUM methodology.
1.3 Examples are given on how to develop a measurement uncertainty budget and a statement of uncertainty.
1.3.1 Key components of uncertainty are derived as part of the derivation of the uncertainty budget. This standard identifies which components of uncertainty are carried forward as part of other analyses (e.g., assessment of process capability and process targets, and process variability), and which components from other standards are brought forward into this standard (e.g., precision of the dose measurement, calibration curve fit, and indirect measurement of dose).
1.4 This document is one of a set of standards that provides recommendations for properly 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 ISO/ASTM 52628 related to the evaluation and documentation of the uncertainties associated with measurements made with a dosimetry system. It is intended to be read in conjunction with ISO/ASTM 52628 (Standard Practice for Dosimetry in Radiation Processing), and ISO/ASTM 51261 (Practice for Calibration of Routine Dosimetry Systems for Radiation Processing).
1.5 To achieve compliance with the requirements of ISO 11137-1 (radiation sterilization of health care products), ISO 14470 (treatment of food), and other applications, a measurement is accompanied by a statement of the uncertainty.
1.6 This guide does not address the establishment of process specifications or conformity assessment.
1.7 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.
1.8 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.
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