【英文标准名称】:StandardPracticeforInterlaboratoryQuantitationEstimate
【原文标准名称】:实验室间定量评估的标准实施规程
【标准号】:ASTMD6512-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:D19.02
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:实验室;质量;定量
【英文主题词】:criticallimit;matrixeffects;precision;quantitation;quantitationlimit
【摘要】:AppropriateapplicationofthispracticeshouldresultinanIQEachievablebymostlaboratoriesproperlyusingthetestmethodstudied.Thatis,mostlaboratoriesshouldbecapableofmeasuringconcentrationsgreaterthanIQEZ%withRSD=Z%orless.TheIQEprovidesthebasisforanyprospectiveuseofthetestmethodbyqualifiedlaboratoriesforreliablequantitationoflow-levelconcentrationsofthesameanalyteastheonestudiedinthispractice,andsamemedia(matrix).TheIQEvaluesmaybeusedtocomparethequantitationcapabilityofdifferentmethodsforanalysisofthesameanalyteinthesamematrix.TheIQEisnotanindicatorofindividuallaboratoryperformance.TheIQEprocedureshouldbeusedtoestablishtheinterlaboratoryquantitationcapabilityforanyapplicationofamethodwhereinterlaboratoryquantitationisimportanttodatause.TheintentoftheIQEisnottosetreportinglimits.1.1ThispracticeestablishesauniformstandardforcomputingtheinterlaboratoryquantitationestimateassociatedwithZ%relativestandarddeviation(referredtohereinasIQEZ%),andprovidesguidanceconcerningtheappropriateuseandapplication.ThecalculationsinvolvedinthispracticecanbeperformedwithDQCALC,MicrosoftExcel-basedsoftwareavailablefromASTM.1.2IQEZ%iscomputedtobethelowestconcentrationforwhichasinglemeasurementfromalaboratoryselectedfromthepopulationofqualifiedlaboratoriesrepresentedinaninterlaboratorystudywillhaveanestimatedZ%relativestandarddeviation(Z%RSD,basedoninterlaboratorystandarddeviation),whereZistypicallyanintegermultipleof10,suchas10,20,or30,butZcanbelessthan10.TheIQE10%isconsistentwiththequantitationapproachesofCurrie(1)andOppenheimer,etal(2).1.3Thefundamentalassumptionofthecollaborativestudyisthatthemediatested,theconcentrationstested,andtheprotocolfollowedinthestudyprovidearepresentativeandfairevaluationofthescopeandapplicabilityofthetestmethodaswritten.Properlyapplied,theIQEprocedureensuresthattheIQEhasthefollowingproperties:1.3.1RoutinelyAchievableIQEValue8212;MostlaboratoriesareabletoattaintheIQEquantitationperformanceinroutineanalyses,usingastandardmeasurementsystem,atreasonablecost.Thispropertyisneededforaquantitationlimittobefeasibleinpracticalsituations.RepresentativelaboratoriesmustbeincludedinthedatatocalculatetheIQE.1.3.2AccountingforRoutineSourcesofError8212;TheIQEshouldrealisticallyincludesourcesofbiasandvariationthatarecommontothemeasurementprocess.Thesesourcesinclude,butarenotlimitedto:intrinsicinstrumentnoise,some"typical"amountofcarryovererror;plusdifferencesinlaboratories,analysts,samplepreparation,andinstruments.1.3.3AvoidableSourcesofErrorExcluded8212;TheIQEshouldrealisticallyexcludeavoidablesourcesofbiasandvariation;thatis,thosesourcesthatcanreasonablybeavoidedinroutinefieldmeasurements.Avoidablesourceswouldinclude,butarenotlimitedto:modificationstothesample;modificationstothemeasurementprocedure;modificationstothemeasurementequipmentofthevalidatedmethod,andgrossandeasilydiscernibletranscriptionerrors,providedtherewasawaytodetectandeithercorrectoreliminatethem.1.4TheIQEappliestomeasurementmethodsforwhichcalibrationerrorisminorrelativetoothersources,suchaswhenthedominantsourceofvariationisoneofthefollowing:1.4.1SamplePreparation,andcalibrationstandardsdonothavetogothroughsamplepreparation.1.4.2DifferencesinAnalysts,andanalystshavelittleopportunitytoaffectcalibrationr......
【中国标准分类号】:A00
【国际标准分类号】:03_120_20
【页数】:14P.;A4
【正文语种】: