STM_51261-13.pdf

ISO/ASTM 51261:2013(E)Standard Practice forCalibration of Routine Dosimetry Systems for RadiationProcessing1This standard is issued under the fixed designation ISO/ASTM 51261;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 practice specifies the requirements for calibratingroutine dosimetry systems for use in radiation processing,including establishing measurement traceability and estimatinguncertainty in the measured dose using the calibrated dosim-etry system.NOTE1Regulations or other directives exist in many countries thatgovern certain radiation processing applications such as sterilization ofhealthcare products and radiation processing of food requiring thatabsorbed-dose measurements be traceable to national or internationalstandards(ISO 11137-1,Refs(1-3)2).1.2 The absorbed-dose range covered is up to 1 MGy.1.3 The radiation types covered are photons and electronswith energies from 80 keV to 25 MeV.1.4 This document is one of a set of standards that providesrecommendations for properly implementing dosimetry inradiation processing,and describes a means of achievingcompliance with the requirements of ASTM E2628“Practicefor Dosimetry in Radiation Processing”for the calibration ofroutine dosimetry systems.It is intended to be read in conjunc-tion with ASTM E2628 and the relevant ASTM or ISO/ASTMstandard practice for the dosimetry system being calibratedreferenced in Section 2.1.5 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:3E170 Terminology Relating to Radiation Measurements andDosimetryE178 Practice for Dealing With Outlying ObservationsE2628 Practice for Dosimetry in Radiation ProcessingE2701 Guide for Performance Characterization of Dosim-eters and Dosimetry Systems for Use in Radiation Pro-cessing2.2 ISO/ASTM Standards:351607 Practice for Use of an Alanine-EPR Dosimetry Sys-tem51707 Guide for Estimating Uncertainties in Dosimetry forRadiation Processing2.3 International Commission on Radiation Units and Mea-surements Reports:4ICRU Report 85a Fundamental Quantities and Units forIonizing Radiation2.4 ISO Standards:5ISO 11137-1 Sterilization of health care productsRadiationRequirements for the development,validationand routine control of a sterilization process for medicaldevices2.5 ISO/IEC Standards:517025 General Requirements for the Competence of Testingand Calibration Laboratories1This 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 Aug.16,2012.Published April 2013.Originallypublished as ASTM E 1261 88.Last previous ASTM edition E 1261 00.ASTME 1261 941was adopted by ISO in 1998 with the intermediate designation ISO15556:1998(E).The present International Standard ISO/ASTM 51261:2013(E)is amajor revision of ISO/ASTM 51261:2002(E),which replaced ISO 15556.2The boldface numbers given in parentheses refer to the bibliography at the endof this guide.3For 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.4AvailablefromInternationalCommissiononRadiationUnitsandMeasurements,7910 Woodmont Avenue,Suite 800,Bethesda,MD 20814,USA.5Available from International Organization for Standardization(ISO),1,ch.dela Voie-Creuse,Case postale 56,CH-1211,Geneva 20,Switzerland,http:/www.iso.ch.ISO/ASTM International 2015 All rights reserved1 2.6 Joint Committee for Guides in Metrology(JCGM)Reports:6JCGM 100:2008,GUM 1995,with minor corrections,Evaluation of measurement data Guide to the Expres-sion of Uncertainty in Measurement3.Terminology3.1 Definitions:3.1.1 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 17025.3.1.1.1 DiscussionA recognized national metrology insti-tute or other calibration laboratory accredited to ISO/IEC17025 should be used in order to ensure traceability to anational or international standard.A calibration certificateprovided by a laboratory not having formal recognition oraccreditation will not necessarily be proof of traceability to anational or international standard.3.1.2 calibrationset of operations that establish,underspecified conditions,the relationship between values of quan-tities indicated by a measuring instrument or measuringsystem,or values represented by a material measure or areference material,and the co