ASTM E2303-2003 辐射处理设施中吸收剂量标记的标准指南

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【英文标准名称】:StandardGuideforAbsorbed-DoseMappinginRadiationProcessingFacilities
【原文标准名称】:辐射处理设施中吸收剂量标记的标准指南
【标准号】:ASTME2303-2003
【标准状态】:现行
【国别】:
【发布日期】:2003
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:E10.01
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:吸收剂量;辐射;处理;标记
【英文主题词】:absorbeddose;Bremsstrahlung;dosedistribution;dosemapping;dosezone;dosimetry;electronbeam;gammarays;irradiatorcharacterization;maximumdose;minimumdose;operationalqualification;performancequalification;radiationprocessi
【摘要】:Radiationprocessingiscarriedoutunderfixedpathconditionswhere(a)aprocessloadisautomaticallymovedthroughtheradiationfieldbymechanicalmeansor(b)aprocessloadisirradiatedstaticallybymanuallyplacingproductatpredeterminedpositionsbeforetheprocessisstarted.Inbothcasestheprocessiscontrolledinsuchamannerthattheprocessloadposition(s)andorientation(s)arereproduciblewithinspecifiedlimits.Someradiationprocessingfacilitiesthatutilizeafixedconveyorpathforroutineprocessingmayalsocharacterizearegionwithintheradiationfieldforstaticradiationprocessing,sometimesreferredtoasx201C;OffCarrierx201D;processing.Radiationprocessingmayrequireaminimumabsorbeddose(toachieveadesiredeffectortofulfillalegalrequirement),andamaximumdosethatcanbetolerated(whiletheproduct,materialorsubstancestillmeetsfunctionalspecificationsortofulfillalegalrequirement).Dosemappingisusedtocharacterizetheradiationprocessandassessthereproducibilityofabsorbed-doseresults,whichmaybeusedaspartofoperationalqualificationandperformancequalification.Dosemappingisusedtodeterminethespatialdistributionofabsorbeddosesandthezone(s)ofmaximumandminimumabsorbeddosesthroughoutaprocessload,whichmayconsistofanactualorsimulatedproduct.Dosemappingisusedtoestablishtherelationshipbetweenthedoseatareferencepositionandthedosewithintheminimumandmaximumdosezonesestablishedforaprocessload.Dosemappingisusedtoverifymathematicaldosecalculationmethods.SeeGuideE2232.Dosemappingisusedtodeterminetheprocessshutdownandstartuptransitdoseeffectonthedistributionofabsorbeddoseandthemagnitudeoftheminimumandmaximumdoses.Dosemappingisusedtoassesstheimpactonthedistributionofabsorbeddoseandthemagnitudeoftheminimumandmaximumdosesresultingfromthetransitionfromoneprocessloadtoanotherwherechanges,forexample,indensityorproductloadingpatternmayoccur.1.1Thisdocumentprovidesguidanceindeterminingabsorbed-dosedistributionsinproducts,materialsorsubstancesirradiatedingamma,X-ray(bremsstrahlung)andelectronbeamfacilities.Note18212;Forirradiationoffoodandtheradiationsterilizationofhealthcareproducts,otherspecificISOandISO/ASTMstandardscontainingdosemappingrequirementsexist.Forfoodirradiation,seeISO/ASTM51204,PracticeforDosimetryinGammaIrradiationFacilitiesforFoodProcessingandISO/ASTM51431,PracticeforDosimetryinElectronandBremsstrahlungIrradiationFacilitiesforFoodProcessing.Fortheradiationsterilizationofhealthcareproducts,seeISO11137:1995,SterilizationofHealthCareProductsRequirementsforValidationandRoutineControlRadiationSterilization.InthoseareascoveredbyISO11137,thatstandardtakesprecedence.ISO/ASTMPractice51608,ISO/ASTMPractice51649,andISO/ASTMPractice51702alsocontaindosemappingrequirements.1.2Methodsofanalyzingthedosemapdataaredescribed.Examplesareprovidedofstatisticalmethodsthatmaybeusedtoanalyzedosemapdata.1.3Dosemappingforbulkflowprocessingandfluidstreamsisnotdiscussed.1.4Dosimetryisonlyonecomponentofatotalqualityprogramforanirradiationfacility.Othercontrolsbesidesdosimetrymayberequiredforspecificapplicationssuchasmedicaldevicesterilizationandfoodpreservation.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresp......
【中国标准分类号】:F80
【国际标准分类号】:13_280
【页数】:9P.;A4
【正文语种】: