STM_51649-15.pdf

ISO/ASTM 51649:2015(E)An American National StandardStandard Practice forDosimetry in an Electron Beam Facility for RadiationProcessing at Energies Between 300 keV and 25 MeV1This standard is issued under the fixed designation ISO/ASTM 51649;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 dosimetric procedures to be fol-lowed in installation qualification(IQ),operational qualifica-tion(OQ)and performance qualifications(PQ),and routineprocessing at electron beam facilities.1.2 The electron beam energy range covered in this practiceis between 300 keV and 25 MeV,although there are somediscussions for other energies.1.3 Dosimetry is only one component of a total qualityassurance program for adherence to good manufacturing prac-tices used in radiation processing applications.Other measuresbesides dosimetry may be required for specific applicationssuch as health care product sterilization and food preservation.1.4 Specific standards exist for the radiation sterilization ofhealth care products and the irradiation of food.For theradiation sterilization of health care products,see ISO 11137-1(Requirements)and ISO 11137-3(Guidance on dosimetricaspects).For irradiation of food,see ISO 14470.In those areascovered by these standards,they take precedence.Informationabout effective or regulatory dose limits for food products isnot within the scope of this practice(seeASTM Guides F1355,F1356,F1736,and F1885).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 ISO/ASTM 52628,“Practice for Dosimetryin Radiation Processing”.NOTE1For guidance in the calibration of routine dosimetry systems,see ISO/ASTM Practice 51261.For further guidance in the use of specificdosimetry systems,see relevant ISO/ASTM Practices.For discussion ofradiation dosimetry for pulsed radiation,see ICRU Report 34.1.6 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 requirements 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 FacilitiesF1355 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-ismsF1736 Guide for Irradiation of Finfish and Aquatic Inverte-brates Used as Food to Control Pathogens and SpoilageMicroorganismsF1885 Guide for Irradiation of Dried Spices,Herbs,andVegetable Seasonings to Control Pathogens and OtherMicroorganisms2.2 ISO/ASTM Standards:251261 Practice for Calibration of Routine Dosimetry Sys-tems for Radiation Processing51275 Practice for Use of a Radiochromic Film DosimetrySystem51539 Guide for the Use of Radiation-Sensitive Indicators51608 Practice for Dosimetry in an X-Ray(Bremsstrahlung)Facility for Radiation Processing51702 Practice for Dosimetry in a Gamma Facility forRadiation Processing51707 Guide for Estimating Uncertainties in Dosimetry forRadiation Processing51818 Practice for Dosimetry in an Electron Beam Facilityfor Radiation Processing at Energies Between 80 and 300keV52628 Practice for Dosimetry in Radiation Processing1This 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 Sept.8,2014.Published February 2015.Originallypublished as E 164994.Last previous ASTM edition E 164900.ASTME 1649941was adopted by ISO in 1998 with the intermediate designation ISO15569:1998(E).The present International Standard ISO/ASTM 51649:2015(E)is amajor revision of the last previous edition ISO/ASTM 51649:2005(E),whichreplaced ISO/ASTM 51649:2002(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.ISO/ASTM International 2015 All rights reserved1 52701 Guide for Performance Characterization of Dosim-eters and Dosimetry Systems for Use in Radiation Pro-cessing2.3 ISO Standards:3ISO 11137-1 Sterilization of Health Care ProductsRadia-tion Part 1:Requirements for development,validation,and routine control of a sterilization process for medicaldevicesISO 11137-3 Sterilization of Health Care ProductsRadia-tion Part 3:G