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【英文标准名称】:PracticeforValidationofProcessStreamAnalyzerSystems
【原文标准名称】:工业生产液流分析仪校验系统的实施规程
【标准号】:ANSI/ASTMD3764-2006
【标准状态】:作废
【国别】:美国
【发布日期】:2006
【实施或试行日期】:2006-07-18
【发布单位】:美国国家标准学会(US-ANSI)
【起草单位】:ANSI
【标准类型】:()
【标准水平】:()
【中文主题词】:流动性;分析仪
【英文主题词】:Abilitiestoflow;Analyzers;Catalysts;Lubricants;Petroleumproducts
【摘要】:ThispracticedescribesproceduresandmethodologiesbasedonthestatisticalprinciplesofPracticeD6708tovalidatewhetherthedegreeofagreementbetweentheresultsproducedbyatotalanalyzersystem(oritssubsystem),versustheresultsproducedbyanindependenttestmethodthatpurportstomeasurethesameproperty,meetsuser-specifiedrequirements.Thisisaperformance-basedvalidation,tobeconductedusingasetofmaterialsthatarenotusedaprioriinthedevelopmentofanycorrelationbetweenthetwomeasurementsystemsunderinvestigation.AresultfromtheindependenttestmethodishereinreferredtoasaPrimaryTestMethodResult(PTMR).ThispracticeassumesanycorrelationnecessarytomitigatesystemicbiasesbetweentheanalyzersystemandPTMhavebeenappliedtotheanalyzerresults.Thispracticerequiresthatboththeprimarymethodagainstwhichtheanalyzeriscomparedto,andtheanalyzersystemunderinvestigation,areinstatisticalcontrol.PracticesdescribedinPracticeD6299shouldbeusedtoensurethisconditionismet.Thispracticeappliesiftheprocessstreamanalyzersystemandtheprimarytestmethodarebasedonthesamemeasurementprinciple(s),or,iftheprocessstreamanalyzersystemusesadirectandwell-understoodmeasurementprinciplethatissimilartothemeasurementprincipleoftheprimarytestmethod.Thispracticealsoappliesiftheprocessstreamanalyzersystemusesadifferentmeasurementtechnologyfromtheprimarytestmethod,providedthatthecalibrationprotocolforthedirectoutputoftheanalyzerdoesnotrequireuseofthePTMRs(seeCase1inNote1).ThispracticedoesnotapplyiftheprocessstreamanalyzersystemutilizesanindirectormathematicallymodeledmeasurementprinciplesuchaschemometricormultivariateanalysistechniqueswherePTMRsarerequiredforthechemometricormultivariatemodeldevelopment.UsersshouldrefertoPracticeD6122fordetailedvalidationproceduresforthesetypesofanalyzersystems(seeCase2in).Note0Forexample,forthemeasurementofbenzeneinsparkignitionfuels,comparisonofaMid-InfraredprocessanalyzersystembasedonTestMethodD6277toaTestMethodD3606gaschromatographyprimarytestmethodwouldbeconsideredCase1,andthispracticewouldapply.Foreachsample,theMid-Infraredspectrumisconvertedintoasingleanalyzerresultusingmethodology(TestMethodD6277)thatisindependentoftheprimarytestmethod(TestMethodD3606).However,whenthesameanalyzerusesamultivariatemodeltocorrelatethemeasuredMid-InfraredspectrumtoTestMethodD3606referencevaluesusingthemethodologyofPracticeE1655,itisconsideredCase2andPracticeD6122applies.Inthiscase2example,thedirectoutputoftheanalyzeristhespectrum,andtheconversionofthismultivariateoutputtoananalyzerresultrequireuseofPracticeD6122,henceitisnotindependentoftheprimarytestmethod.PerformanceValidationisconductedbycalculatingtheprecisionandbiasofthedifferencesbetweenresultsfromtheanalyzersystem(orsubsystem)aftertheapplicationofanynecessarycorrelation,(suchresultsarehereinreferredtoasPredictedPrimaryTestMethodResults(PPTMRs)),versusthePTMRsforthesamesampleset.Resultsusedinthecalculationareforsamplesthatarenotusedinthedevelopmentofthecorrelation.Thecalculatedprecisionandbiasarestatisticallycomparedtouser-specifiedrequirementsfortheanalyzersystemapplication.
【中国标准分类号】:N50
【国际标准分类号】:17_120_10
【页数】:
【正文语种】:英语