STM_51702-13.pdf

ISO/ASTM 51702:2013(E)An American National StandardStandard Practice forDosimetry in a Gamma Facility for Radiation Processing1This standard is issued under the fixed designation ISO/ASTM 51702;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 outlines the installation qualification pro-gram for an irradiator and the dosimetric procedures to befollowed during operational qualification,performance quali-fication,and routine processing in facilities that process prod-ucts with ionizing radiation from radionuclide gamma sourcesto ensure that product has been treated within a predeterminedrange of absorbed dose.Other procedures related to operationalqualification,performance qualification,and routine process-ing that may influence absorbed dose in the product are alsodiscussed.NOTE1Dosimetry is only one component of a total quality assuranceprogram for adherence to good manufacturing practices used in radiationprocessing applications.NOTE2ISO/ASTM Practices 51818 and 51649 describe dosimetricprocedures for low and high enery electron beam facilities for radiationprocessing and ISO/ASTM Practice 51608 describes procedures for X-ray(bremsstrahlung)facilities for radiation processing.1.2 For the radiation sterilization of health care products,see ISO 11137-1.In those areas covered by ISO 11137-1,thatstandard takes precedence.1.3 This document is one of a set of standards that providesrecommendations for properly implementing and utilizingdosimetry in radiation processing.It is intended to be read inconjunction with ASTM Practice E2628.1.4 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 andDosimetryE2232 Guide for Selection and Use of Mathematical Meth-ods for CalculatingAbsorbed Dose in Radiation ProcessingApplicationsE2303 Guide for Absorbed-Dose Mapping in RadiationProcessing FacilitiesE2628 Practice for Dosimetry in Radiation ProcessingE2701 Guide for Performance Characterization of Dosim-eters and Dosimetry Systems for Use in Radiation Process-ing2.2ISO/ASTM Standards:251261 Practice for Calibration of Routine Dosimetry Sys-tems for Radiation Processing51539 Guide for Use of Radiation-Sensitive Indicators51608 Practice for Dosimetry in an X-Ray(Bremsstrahl-ung)Facility for Radiation Processing51649 Practice for Dosimetry in an Electron Beam Facilityfor Radiation Processing at Energies Between 300 KeVand 25 KeV51707 Guide for Estimating Uncertainties in Dosimetry forRadiation Processing51818 Practice for Dosimetry in an Electron Beam Facilityfor Radiation Processing at Energies Between 80 and 300keV2.3International Commission on Radiation Units andMeasurements(ICRU)Reports:3ICRU Report 85a Fundamental Quantities and Units forIonizing Radiation2.4ISO Standards:4ISO 11137-1 Sterilization of health care products Radia-tion Part 1:Requirements for development,validation,and routine control of a sterilization process for medicaldevices2.5Joint Committee for Guides in Metrology(JCGM)Reports:5JCGM 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 absorbed dose,Dquantity of ionizing radiationenergy imparted per unit mass of a specified material.The SI1This practice is under the jurisdiction of ASTM Committee E61 on RadiationProcessing and is the direct responsibility of Subcommittee E61.03 on DosimetryApplication,and is also under the jurisdiction of ISO/TC 85/WG 3.Current edition approved Dec.26,2012.Published April 2013.Originallypublished as E 1702-95.Last previous ASTM edition E 170200.ASTME 1702951was adopted by ISO in 1998 with the intermediate designation ISO15571:1998(E).The present International Standard ISO/ASTM 51702:2013(E)replaces ISO 15571 and is a major revision of the last previous edition ISO/ASTM517022004(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 the International Commission on Radiation Units and Measure-ments,7910 Woodmont Ave.,Suite 800,Bethesda,MD 20814,USA.4Available from International Organization for Standardization(ISO),1 rue deVaremb,Case postale 56,CH-1211,Geneva 20,Switzerland,http:/www.iso.ch.5Document produced by Working Group 1 of the Joint Committee for Guides inMetrology(JCGM/WG 1).Available free of charge at the BIPM website(http:/www.bipm.org).1 ISO/ASTM International 2013 All rights reservedCopyright ASTM International Pr