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1、ISOASTM52303:2015(E)StardGuidefAbsbedDoseMappinginRadiationProcessingFacilities1ThisstardisissuedunderthefixeddesignationISOASTM52303thenumberimmediatelyfollowingthedesignationindicatestheyearofiginaladoptioninthecaseofr

2、evisiontheyearoflastrevision.1.Scope1.1Thisdocumentprovidesguidanceindeterminingabsbeddosedistributions(mapping)inproductsmaterialssubstancesirradiatedingammaXray(bremsstrahlung)electronbeamfacilities.NOTE1—Firradiationo

3、ffoodtheradiationsterilizationofhealthcareproductsspecificISOISOASTMstardscontainingdosemappingrequirementsexist.SeeISOASTMPractices5143151608516495170251818ISO111371.Regardingtheradiationsterilizationofhealthcareproduct

4、sinthoseareascoveredbyISO111371thatstardtakesprecedence.1.2Thisguideisoneofasetofstardsthatprovidesrecommendationsfproperlyimplementingdosimetryinradiationprocessing.itisintendedtobereadinconjunctionwithISOASTM52628.1.3M

5、ethodsofanalyzingthedosemapdataaredescribed.Examplesareprovidedofstatisticalmethodsthatmaybeusedtoanalyzedosemapdata.1.4Dosemappingfbulkflowprocessingfluidstreamsisnotdiscussed.1.5Dosimetryisanelementofatotalqualitymanag

6、ementsystemfanirradiationfacility.Othercontrolsbesidesdosimetrymayberequiredfspecificapplicationssuchasmedicaldevicesterilizationfoodpreservation.1.6Thisstarddoesnotpurpttoaddressallofthesafetyconcernsifanyassociatedwith

7、itsuse.Itistheresponsibilityoftheuserofthisstardtoestablishappropriatesafetyhealthpracticesdeterminetheapplicabilityofregulatyrequirementspritouse.2.ReferencedDocuments2.1ASTMStards:2E170TerminologyRelatingtoRadiationMea

8、surementsDosimetryE178PracticefDealingWithOutlyingObservationsE2232GuidefionUseofMathematicalMethodsfCalculatingAbsbedDoseinRadiationProcessingApplications2.2ISOASTMStards:251261GuidefionCalibrationofDosimetrySystemsfRad

9、iationProcessing51431PracticefDosimetryinElectronBeamXRay(Bremsstrahlung)IrradiationFacilitiesfFoodProcessing51608PracticefDosimetryinanXray(Bremsstrahlung)FacilityfRadiationProcessing51649PracticefDosimetryinanElectronB

10、eamFacilityfRadiationProcessingatEnergiesbetween300keV25MeV51702PracticefDosimetryinaGammaIrradiationFacilityfRadiationProcessing51707GuidefEstimatingUncertaintiesinDosimetryfRadiationProcessing51818PracticefDosimetryina

11、nElectronBeamFacilityfRadiationProcessingatEnergiesbetween80300keV52628PracticefDosimetryinRadiationProcessing2.3InternationalCommissiononRadiationUnitsMeasurementsRepts:3ICRURept85aFundamentalQuantitiesUnitsfIonizingRad

12、iation2.4InternationalganizationfStardization:4ISO111371Sterilizationofhealthcareproducts–Radiation–Part1:Requirementsfdevelopmentvalidationroutinecontrolofasterilizationprocessfmedicaldevices2.5JointCommitteefGuidesinMe

13、trology(JCGM)Repts:JCGM100:2008GUM1995withmincrectionsEvaluationofmeasurementdata–Guidetotheexpressionofuncertaintyinmeasurement51ThisguideisunderthejurisdictionofASTMCommitteeE61onRadiationProcessingisthedirectresponsib

14、ilityofSubcommitteeE61.03onDosimetryApplicationisalsounderthejurisdictionofISOTC85WG3.CurrenteditionapprovedFeb.92015.PublishedJune2015.iginallypublishedasASTME2303–03.LastpreviousASTMeditionE2303–11ε1.ThepresentInternat

15、ionalStardISOASTM52303–2015(E)replacesASTME2303–11ε1.2FreferencedASTMISOASTMstardsvisittheASTMwebsitewww.astm.gcontactASTMCustomerServiceat.FAnnualBookofASTMStardsvolumeinfmationrefertothestard’sDocumentSummarypageontheA

16、STMwebsite.3AvailablefromInternationalCommissiononRadiationUnitsMeasurements7910WoodmontAve.Suite800BethesdaMD20814.4AvailablefromInternationalganizationfStardization(ISO)1ruedeVarembCasepostale56CH1211Geneva20Switzerl.5

17、DocumentproducedbyWkingGroup1oftheJointCommitteefGuidesinMetrology(JCGMWG1).AvailablefreeofgeattheBIPMwebsite(:www.bipm.g).?ISOASTMInternational2015–Allrightsreserved14.4Manyradiationprocessingapplicationsrequireaminimum

18、absbeddose(toachieveadesiredeffecttofulfillalegalrequirement)amaximumabsbeddose(toensurethattheproductmaterialsubstancestillmeetsfunctionalspecificationstofulfillalegalrequirement).4.5Infmationfromthedosemappingisusedto:

19、4.5.1acterizetheradiationprocessassessthereproducibilityofabsbeddosevalueswhichmaybeusedaspartofoperationalqualificationperfmancequalification.4.5.2Determinethespatialdistributionofabsbeddosesthezone(s)ofmaximumminimumab

20、sbeddosesthroughoutaprocessloadwhichmayconsistofanactualsimulatedproduct.4.5.3Establishtherelationshipbetweenthedoseataroutinemonitingpositionthedosewithintheminimummaximumdosezonesestablishedfaprocessload.4.5.4Verifymat

21、hematicaldosecalculationmethods.SeeASTMGuideE2232.4.5.5Determinetheeffectofprocessinterruptionsonthedistributionofabsbeddosethemagnitudeoftheminimummaximumdoses.4.5.6Assesstheimpactonthedistributionofabsbeddosethemagnitu

22、deoftheminimummaximumdosesresultingfromthetransitionfromoneprocessloadtoanotherwherechangesfexampleinproductdensityproductloadingpatternmayoccur.5.Prerequisites5.1PrerequisitestoDoseMapping:InstallationQualificationDosim

23、etrySystemCalibration:5.1.1Pritoperfmingdosemappingfirradiatoperationalqualification(OQ)perfmancequalification(PQ)confirmthatinstallationqualification(IQ)iscomplete.5.1.1.1FelectronbeamXrayirradiationfacilitiesIQincludes

24、dosimetrictestingtoconfirmtheacteristicsofthebeam(electronenergyaveragebeamcurrentifapplicablescanwidthscanunifmity).RefertoISOASTM51431516085181851649ISO111371.5.1.1.2Fgammairradiationfacilitiesdosimetrictestingisnotreq

25、uiredduringIQhowevertheactivityofthesourcelocationoftheindividualcomponentsofthesourceshouldbeconfirmeddocumented.RefertoISOASTM51702ISO111371.5.1.2anappropriatedosimetrysystem(s)fthedosemappingexercises.See6.2.4.1ISOAST

26、M52628fguidance.5.2CalibrationoftheDosimetrySystem:5.2.1Pritousethedosimetrysystemconsistingofdosimetersmeasurementinstrumentstheirassociatedreferencestardsproceduresfthesystem’suseshouldbecalibratedinaccdancewiththeuser

27、’sdocumentedprocedurethatspecifiesdetailsofthecalibrationprocessqualityassurancerequirements.CalibrationmethodsaredescribedinISOASTM51261.NOTE3—Adosimetrysystemcalibrationobtainedusingirradiationconditionsdifferentfromth

28、econditionsofusemaybeusedfrelativedosemeasurementapplications.Fexampleanirradiationfacilitymayperfmalabbasedcalibrationwithsubsequentverificationusingreferencestarddosimetersundertheconditionsofuse.Whiledosemappingatthei

29、rradiationfacilitymaybeperfmedusingdosevaluesfromthelabbasedcalibration(pritocompletingtheverificationexercise)toassessthedosedistributionlocationsofminimummaximumabsbeddosethesedosemeasurementswouldbeconsideredprelimina

30、ry(i.e.relative)pendingtheoutcomeoftheverificationexercise.5.2.2FthecalibrationoftheinstrumentsftheverificationofinstrumentperfmancebetweencalibrationsseeISOASTM51261instrumentspecificoperatingmanualsboth.6.Dosemapping6.

31、1DoseMappingfOperationalQualificationoftheIrradiationFacility:6.1.1AsspecifiedinISOASTMPractices51431516085164951702ISO111371perfmirradiationfacilitydosemappingtoacterizetheirradiatwithrespecttothedosedistributionreprodu

32、cibilityofabsbeddosedelivery.Thisshouldbeperfmedinaccdancewithafmalvalidationprogramshouldcovertheoperationalrangethatwillbeusedintheirradiationofproducts.6.1.2Perfmirradiationfacilitydosemappingbyplacingdosimetersinanum

33、berofprocessloadsofreferencematerialthatfillsthecontainertoitsdesignvolumelimits.Thenumberofprocessloadstobedosemappedshouldbelargeenough(3me)todeterminethevariabilityofdose.Fthoseirradiationfacilitiesthatvaryoperatingpa

34、rameterswhichimpactdosedistributiondosemappingshouldbecarriedoutoverarangeofedoperatingparameterswhichcovertheoperationallimitstobeusedintheirradiationofproducts.6.1.2.1SpecifictoPhotonbasedFacilities(gammaXray)—Material

35、densitiesshouldbewithinthedensityrangefwhichtheirradiatistobeused.Whenprocessingmultipledensitiesdosemappingshouldbedonefatleasttwodensitiesclosetotheminimummaximumdensitytobeprocessedtoassesstheimpactdensityhasonthemagn

36、itudedistributionoftheabsbeddose.Ausermayconsiderdosemappingfadditionalintermediatedensitiestogainadditionalperfmanceinfmation.6.1.2.2SpecifictoElectronBeamFacilities—Firradiationfacilitydosemappinguseonemereferencemater

37、ialshavingdensitieswithinthedensityrangefwhichtheirradiatistobeused.6.1.2.3Determineabsbeddosedistributionthroughouttheprocessloadfeachproductpaththroughtheirradiationfieldeachsetofprocessparameters.NOTE4—Additionalwayst

38、oinfluencetheabsbeddosedistributionwithinagivenprocessloadinclude:perfmingsingleversusdoublesidedirradiationinelectronbeamXrayfacilitiesusingmultiplesourcerack(s)sourcerackpositioningchangesingammairradiats.6.1.2.4Feachp

39、rocessloadplaceasufficientnumberofdosimetersinanarraytodeterminetheabsbeddosedistribution.Dosimeterstripssheetsmaybeusedtoincreasethespatialresolutionofthedosemap.AnexampleofdosimeterplacementarrayisgiveninFig.1.6.1.2.5M

40、easurethedoseatthesamepositionsinthreemereplicateprocessloadstodeterminethevariabilityofthemeasuredabsbeddoseabsbeddosedistributionfeachproductpathsetofprocessparameters.ISOASTM52303:2015(E)3?ISOASTMInternational2015–All

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