ANSI/ASTM D6122-2006 多变量过程红外分光光度计确认惯例

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【英文标准名称】:PracticeforValidationofMultivariateProcessInfraredSpectrophotometers
【原文标准名称】:多变量过程红外分光光度计确认惯例
【标准号】:ANSI/ASTMD6122-2006
【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】:分光光度计;证实
【英文主题词】:Controlcharts;Optics;Processinstruments;Spectrophotometers;Validation
【摘要】:Thispracticecoversrequirementsforthevalidationofmeasurementsmadebyonline,processnear-ormid-infraredanalyzers,orboth,usedinthecalculationofphysical,chemical,orqualityparameters(thatis,properties)ofliquidpetroleumproducts.Thepropertiesarecalculatedfromspectroscopicdatausingmultivariatemodelingmethods.Therequirementsincludeverificationofadequateinstrumentperformance,verificationoftheapplicabilityofthecalibrationmodeltothespectrumofthesampleundertest,andverificationofequivalencebetweentheresultcalculatedfromtheinfraredmeasurementsandtheresultproducedbytheprimarytestmethodusedforthedevelopmentofthecalibrationmodel.Whenthereisadequatevariationinpropertylevel,thestatisticalmethodologyofPracticeD6708isusedtoprovidegeneralvalidationofthisequivalenceoverthecompleteoperatingrangeoftheanalyzer.Forcaseswherethereisinadequatepropertyvariation,methodologyforlevelspecificvalidationisused.PerformanceValidationisconductedbycalculatingtheprecisionandbiasofthedifferencesbetweenresultsfromtheanalyzersystem(orsubsystem)producedbyapplicationofthemultivariatemodel,(suchresultsarehereinreferredtoasPredictedPrimaryTestMethodResults(PPTMRs)),versusthePrimaryTestMethodResults(PTMRs)forthesamesampleset.Resultsusedinthecalculationareforsamplesthatarenotusedinthedevelopmentofthemultivariatemodel.Thecalculatedprecisionandbiasarestatisticallycomparedtouser-specifiedrequirementsfortheanalyzersystemapplication.Foranalyzersusedinproductreleaseorproductqualitycertificationapplications,theprecisionandbiasrequirementforthedegreeofagreementaretypicallybasedonthesiteorpublishedprecisionofthePrimaryTestMethod.Note1Inmostapplicationsofthistype,thePTMisthespecification-citedtestmethod.Thispracticedoesnotdoesnotdescribeproceduresforestablishingprecisionandbiasrequirementsforanalyzersystemapplications.Suchrequirementsmustbebasedonthecriticalityoftheresultstotheintendedbusinessapplicationandoncontractualandregulatoryrequirements.Theusermustestablishprecisionandbiasrequirementspriortoinitiatingthevalidationproceduresdescribedherein.Thispracticedoesnotcoverproceduresforestablishingthecalibrationmodel(correlation)usedbytheanalyzer.CalibrationproceduresarecoveredinPracticesE1655andreferencestherein.Thispracticeisintendedasareviewforexperiencedpersons.Fornovices,thispracticewillserveasanoverviewoftechniquesusedtoverifyinstrumentperformance,toverifymodelapplicabilitytothespectrumofthesampleundertest,andtoverifyequivalencebetweentheparameterscalculatedfromtheinfraredmeasurementandtheresultsoftheprimarytestmethodmeasurement.Thispracticeteachesandrecommendsappropriatestatisticaltools,outlierdetectionmethods,fordeterminingwhetherthespectrumofthesampleundertestisamemberofthepopulationofspectrausedfortheanalyzercalibration.Thestatisticaltoolsareusedtodetermineiftheinfraredmeasurementresultsinavalidpropertyorparameterestimate.Theoutlierdetectionmethodsdonotdefinecriteriatodeterminewhetherthesampleortheinstrumentisthecauseofanoutliermeasurement.Thus,theoperatorwhoismeasuringsamplesonaroutinebasiswillfindcriteriatodeterminethataspectralmeasurementliesoutsidethecalibration,butwillnothavespecificinformationonthecauseoftheoutlier.Thispracticedoessuggestmethodsbywhichinstrumentperformancetestscanbeusedtoindicateiftheoutliermethodsarerespondingtochangesintheinstrumentresponse.
【中国标准分类号】:N50
【国际标准分类号】:17_180_30
【页数】:
【正文语种】:英语