STM_51939-17.pdf

ISO/ASTM 51939:2017(E)Standard Practice forBlood Irradiation Dosimetry1This standard is issued under the fixed designation ISO/ASTM 51939;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 irradiator installation qualifi-cation program and the dosimetric procedures to be followedduring operational qualification and performance qualificationof the irradiator.Procedures for the routine radiation process-ing of blood product(blood and blood components)are alsogiven.If followed,these procedures will help ensure that bloodproductexposedtogammaradiationorX-radiation(bremsstrahlung)will receive absorbed doses with a specifiedrange.1.2 This practice covers dosimetry for the irradiation ofblood product for self-contained irradiators(free-standingirradiators)utilizing radionuclides such as137Cs and60Co,orX-radiation(bremsstrahlung).The absorbed dose range forblood irradiation is typically 15 Gy to 50 Gy.1.3 The photon energy range of X-radiation used for bloodirradiation is typically from 40 keV to 300 keV.1.4 This practice also covers the use of radiation-sensitiveindicators for the visual and qualitative indication that theproduct has been irradiated(see ISO/ASTM Guide 51539).1.5 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 ISO/ASTM Practice52628 for dosimetry performed for blood irradiation.It isintended to be read in conjunction with ISO/ASTM Practice52628.1.6 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 to determine theapplicability or regulatory limitations prior to use.2.Referenced documents2.1 ASTM Standards:2E170 Terminology Relating to Radiation Measurements andDosimetry2.2 ISO/ASTM Standards:251026 Practice for Using the Fricke Dosimetry System51261 Practice for Calibration of Routine Dosimetry Sys-tems for Radiation Processing51275 Practice for Use of a Radiochromic Film DosimetrySystem51310 Practice for Use of a Radiochromic Optical Wave-guide Dosimetry System51539 Guide for the Use of Radiation-Sensitive Indicators51607 Practice for Use of the Alanine-EPR Dosimetry Sys-tem51707 Guide for Estimating Uncertainties in Dosimetry forRadiation Processing51956 Practice for Use of Thermoluminescence-DosimetrySystems(TLD Systems)for Radiation Processing52116 Practice for Dosimetry for a Self-Contained Dry-Storage Gamma-Ray Irradiator52628 Practice for Dosimetry in Radiation Processing52701 Guide for Performance Characterization of Dosim-eters and Dosimetry Systems for Use in Radiation Pro-cessing2.3 International Commission on Radiation Units and Mea-surements Reports(ICRU):3ICRU 80 Dosimetry Systems for Use in Radiation Process-ingICRU 85a Fundamental Quantities and Units for IonizingRadiation1This practice is under the jurisdiction of ASTM Committee E61 on RadiationProcessing and is the direct responsibility of Subcommittee E61.04 on SpecialtyApplication,and is also under the jurisdiction of ISO/TC 85/WG 3.Current edition approved Jan.16,2017.Published February 2017.Originallypublished as ASTM E 193998.Last previous ASTM edition E 193998.Thepresent International Standard ISO/ASTM 51939:2017(E)is a revision of the lastprevious edition ISO/ASTM 51939:05(2013)(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 andMeasurements,7910 Woodmont Ave.,Suite 800,Bethesda,MD 20814 U.S.A.ISO/ASTM International 2017 All rights reservedThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.12.4 ISO Standards:412749-4 Nuclear energy Vocabulary Part 4:Dosimetryfor radiation processing2.5 ISO/IEC Standards:417025 General Requirements for the Competence of Testingand Calibration Laboratories2.6 Guidelines on Blood Irradiation:Guidelines on the Use of Irradiated Blood Components(2013),Prepared by the BCSH Blood Transfusion TaskForce5Recommendations Regarding License Amendments andProcedures for Gamma Irradiation of Blood Products,(1993)US Food and Drug Administration6Guidance for Industry,Gamma Irradiation of Blood andBlood Components:A Pilot Program for Licensing(2000)US Food and Drug Administration62.7 Joint Committee for Guides in Metrology(JCGM)Reports:JCGM 100:2008 GUM 19