STM_51707-15.pdf

ISO/ASTM 51707:2015(E)An American National StandardStandard Guide forEstimation of Measurement Uncertainty in Dosimetry forRadiation Processing1This standard is issued under the fixed designation ISO/ASTM 51707;the number immediately following the designation indicates theyear of original adoption or,in the case of revision,the year of last revision.1.Scope1.1 This standard provides guidance on the use of conceptsdescribed in the JCGM Evaluation of Measurement Data Guide to the Expression of Uncertainty in Measurement(GUM)to estimate the uncertainties in the measurement ofabsorbed dose in radiation processing.1.2 Methods are given for identifying,evaluating and esti-mating the components of measurement uncertainty associatedwith the use of dosimetry systems and for calculating com-bined standard measurement uncertainty and expanded(over-all)uncertainty of dose measurements based on the GUMmethodology.1.3 Examples are given on how to develop a measurementuncertainty budget and a statement of uncertainty.1.4 This document is one of a set of standards that providesrecommendations for properly implementing dosimetry inradiation processing,and provides guidance for achievingcompliance with the requirements of ISO/ASTM 52628 relatedto the evaluation and documentation of the uncertaintiesassociated with measurements made with a dosimetry system.It is intended to be read in conjunction with ISO/ASTM 52628,ISO/ASTM 51261 and ISO/ASTM 52701.1.5 This guide does not address the establishment of processspecifications or conformity assessment.1.6 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced documents2.1 ASTM Standards:2E170 Terminology Relating to Radiation Measurements andDosimetryE456 Terminology Relating to Quality and Statistics2.2 ISO/ASTM Standards:251261 Practice for Calibration of Routine Dosimetry Sys-tems for Radiation Processing51608 Practice for Dosimetry in an X-Ray(Bremsstrahlung)Facility for Radiation Processing51649 Practice for Dosimetry in an Electron Beam Facilityfor Radiation Processing at Energies Between 300 keVand 25 MeV51702 Practice for Dosimetry in a Gamma Facility forRadiation Processing52628 Practice for Dosimetry in Radiation Processing52701 Guide for Performance Characterization of Dosim-eters and Dosimetry systems for Use in Radiation Pro-cessing2.3 ISO Documents:ISO 11137-1 Sterilization of Health Care Products Radia-tion Requirements for Development,Validation andRoutine Control of a Sterilization Process3ISO/IEC 17025 General Requirements for the Competenceof Testing and Calibration Laboratories41This guide is under the jurisdiction of ASTM Committee E61 on RadiationProcessing and is the direct responsibility of Subcommittee E61.01 on Dosimetry,and is also under the jurisdiction of ISO/TC 85/WG 3.Current edition approved by ASTM Sept.8,2014.Published February 2015.Originally published as ASTM E 170795.Last previous ASTM editionE 1707951.ASTM E 1707951was adopted by ISO in 1998 with the intermediatedesignation ISO 15572:1998(E).The present International Standard ISO/ASTM51707:2015(E)is a major revision of the last previous edition ISO/ASTM51707:2005(E),which replaced ISO/ASTM 51707:2002(E).2For referenced ASTM and ISO/ASTM standards,visit the ASTM website,www.astm.org,or contact ASTM Customer Service at serviceastm.org.ForAnnual Book of ASTM Standards volume information,refer to the standardsDocument Summary page on the ASTM website.3Available from Association for the Advancement of Medical Instrumentation,1110 North Glebe Road,Suite 220,Arlington,VA 22201-4795,U.S.A.4Available from International Organization for Standardization(ISO),1,ch.dela Voie-Creuse,CP 56,CH-1211 Geneva 20,Switzerland,http:/www.iso.org.ISO/ASTM International 2015 All rights reserved1 2.4 Joint Committee for Guides in Metrology(JCGM)Reports:JCGM100:2008,GUM1995,withminorcorrec-tions,Evaluation of measurement data Guide to theExpression of Uncertainty in Measurement5JCGM 200:2008,VIM,International vocabulary of metrol-ogy Basis and general concepts and associated terms62.5 ICRU Reports:7ICRU Report 80 Dosimetry Systems for Use in RadiationProcessingICRU Report 85a Fundamental Quantities and Units forIonizing Radiation3.Terminology3.1 Definitions:NOTE1For definitions quoted here from VIM,only the text of thedefinition is kept here.Any NOTES or EXAMPLES are not included.They can be reviewed by referring to VIM(JCGM 200:2008).3.2 Definitions:3.2.1 approved laboratorylaboratory that is a recognizednational metrology institute;or has been formally accredited toISO/IEC 17025;or has a quality system consistent with therequirements of ISO/IEC 17025.3.2.1.1 DiscussionA recognized national metrology insti-tute or other calibration laboratory accredited to ISO/IEC17025 should be used for