STM_51608-15.pdf

ISO/ASTM 51608:2015(E)An American National StandardStandard Practice forDosimetry in an X-Ray(Bremsstrahlung)Facility forRadiation Processing at Energies between 50 keV and 7.5MeV1This standard is issued under the fixed designation ISO/ASTM 51608;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 dosimetric procedures to befollowedduringinstallationqualification,operationalqualification,performance qualification and routine processingat an X-ray(bremsstrahlung)irradiator.Other proceduresrelated to operational qualification,performance qualificationand routine processing that may influence absorbed dose in theproduct are also discussed.NOTE1Dosimetry is only one component of a total quality assuranceprogram for adherence to good manufacturing practices used in radiationprocessing applications.NOTE2ISO/ASTM Practices 51649,51818 and 51702 describedosimetric procedures for electron beam and gamma facilities for radia-tion processing.1.2 For radiation sterilization of health care products,seeISO 11137-1,Sterilization of health care products Radiation Part 1:Requirements for development,validation androutine control of a sterilization process for medical devices.Inthose areas covered by ISO 11137-1,that standard takesprecedence.1.3 For irradiation of food,see ISO 14470,Food irradiation Requirements for development,validation and routine con-trol of the process of irradiation using ionizing radiation forthe treatment of food.In those areas covered by ISO 14470,that standard takes precedence.1.4 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 Practice 52628,“Practice forDosimetry in Radiation Processing”.1.5 In contrast to monoenergetic gamma radiation,theX-ray energy spectrum extends from low values(about 35keV)up to the maximum energy of the electrons incident onthe X-ray target(see Section 5 and Annex A1).1.6 Information about effective or regulatory dose limits andenergy limits for X-ray applications is not within the scope ofthis practice.1.7 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 Facilities2.2 ISO/ASTM Standards:251261 Practice for Calibration of Routine Dosimetry Sys-tems for Radiation Processing51539 Guide for Use of Radiation-Sensitive Indicators51649 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 Processing51707 Guide for Estimating Uncertainties in Dosimetry forRadiation Processing51818 Practice for Dosimetry in an Electron Beam Facilityfor Radiation Processing at Energies Between 80and 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 ASTM E 160894.Last previous ASTM edition E 160800.ASTM E160894 was adopted by ISO in 1998 with the intermediate designation ISO15567:1998(E).The present International Standard ISO/ASTM 51608:2015(E)is amajor revision of the last previous edition ISO/ASTM 51608:2005(E),whichreplaced ISO/ASTM 51608:2002(E).2For referenced ASTM or 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 Process-ing2.3 ISO Standards:3ISO 11137-1 Sterilization of health care products Radia-tion Part 1:Requirements for development,validationand routine control of a sterilization process for medicaldevicesISO 14470 Food irradiation Requirements for thedevelopment,validation and routine control of the processof irradiation using ionizing radiation for the treatment offood2.4 International Commission on Radiation Units and Mea-surements(ICRU)Reports:4ICRU Report 14 Radiation Dosimetry:X Rays and GammaRays with Maximum Photon Energies Between 0.6 and 50MeVICRU