STM_51818-13.pdf

ISO/ASTM 51818:2013(E)Standard Practice forDosimetry in an Electron Beam Facility for RadiationProcessing at Energies Between 80 and 300 keV1This standard is issued under the fixed designation ISO/ASTM 51818;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 covers dosimetric procedures to be fol-lowed in installation qualification,operational qualification andperformance qualification(IQ,OQ,PQ),and routine process-ing at electron beam facilities to ensure that the product hasbeen treated with an acceptable range of absorbed doses.Otherprocedures related to IQ,OQ,PQ,and routine product pro-cessing that may influence absorbed dose in the product arealso discussed.1.2 The electron beam energy range covered in this practiceis between 80 and 300 keV,generally referred to as low energy.1.3 Dosimetry is only one component of a total qualityassurance program for an irradiation facility.Other measuresmay be required for specific applications such as medicaldevice sterilization and food preservation.1.4 Other specific ISO and ASTM standards exist for theirradiation of food and the radiation sterilization of health careproducts.For the radiation sterilization of health care products,see ISO 11137.In those areas covered by ISO 11137,thatstandard takes precedence.For food irradiation,see ISO14470:2011.Information about effective or regulatory doselimits for food products is not within the scope of this practice(see ASTM F1355 and F1356).1.5 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 E2232,“Practice for Dosimetry inRadiation Processing”.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 andDosimetryE2232 Guide for Selection and Use of Mathematical Meth-ods for Calculating Absorbed Dose in Radiation Process-ing ApplicationsE2303 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 Pro-cessingF1355 Guide for Irradiation of FreshAgricultural Produce asa Phytosanitary TreatmentF1356 Practice for Irradiation of Fresh and Frozen Red Meatand Poultry to Control Pathogens and Other Microorgan-isms2.2 ISO Standards:311137-1:2006 Sterilization of health care productsRadia-tionPart 1:Requirements for development,validationand routine control of a sterilization process for medicaldevices14470:2011 FoodirradiationRequirementsforthedevelopment,validation and routine control of the ioniz-ing radiation used for the treatment of food17025:2005 General requirements for the competence oftesting and calibration laboratories2.3 ISO/ASTM Standards:251261 Practice for Calibration of Routine Dosimetry Sys-tems for Radiation Processing51275 Practice for Use of a Radiochromic Film DosimetrySystem51607 Practice for Use of an Alanine-EPR Dosimetry Sys-tem51649 Practice for Dosimetry in an Electron Beam Facility1This 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 April 9,2013.Published June 2013.Originallypublished as ASTM E181896.Last previous ASTM edition E1818961.ASTME1818961was adopted in 1998 with the intermediate designation ISO15573:1998(E).The present Third Edition of International Standard ISO/ASTM51818:2013(E)is a major revision of the Second Edition of ISO/ASTM51818:2009(E).2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available 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 for Radiation Processing at Energies between 300 keV and25 MeV51650 Practice for Use of a Cellulose Triacetate DosimetrySystem51707 Guide for Estimating Uncertainties in Dosimetry forRadiation Processing2.4 International Commission on Radiation Units and Mea-surements(ICRU)Report:4ICRU Report 85a Fundamental Quantities and Units forIonizing RadiationICRU Report 80 Dosimetry Systems for Use in RadiationProcessing3.Terminology3.1 Definitions:3.1.1 absorbed dose(D)quantity of ionizing radiationenergy imparted per unit mas