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1、Thirdedition2006?ISO2006GUIDE35Referencematerials—GeneralstatisticalprinciplesfcertificationISOGUIDE35:2006(E)?ISO2006–AllrightsreservediiiContentsPageFewd.................................................................
2、............................................................................................vIntroduction...................................................................................................................
3、....................................vi1Scope.....................................................................................................................................................12Nmativereferences........
4、...................................................................................................................13Termsdefinitionssymbols................................................................................
5、..........................24Symbols.................................................................................................................................................35Designofacertificationproject.........
6、.................................................................................................45.1General................................................................................................................
7、...................................45.2Projectdefinition...................................................................................................................................55.3Transptissues................
8、...................................................................................................................55.4Collectionofstartingmaterial.........................................................................
9、....................................55.5Feasibilitystudy....................................................................................................................................65.6Requiredlifetimeshelflife...
10、.........................................................................................................65.7Samplepreparation..............................................................................................
11、................................65.8Homogeneitystudy...............................................................................................................................85.9Stabilitystudy.......................
12、................................................................................................................85.10Choiceofmeasurementmethods.............................................................................
13、..........................95.11Certification.........................................................................................................................................105.12Summaryofprojectdesign...........
14、....................................................................................................106Evaluatingmeasurementuncertainty.....................................................................................
15、..........116.1Basisfevaluatingtheuncertaintyofapropertyvalueofa(C)RM............................................116.2Basicmodelfabatchacterization.........................................................................
16、...............126.3Uncertaintysources...........................................................................................................................136.4Issueswithdistributionfunctions.......................
17、.............................................................................136.5Useofratios...............................................................................................................................
18、.........146.6Choiceofacoveragefact...............................................................................................................146.7Recertification......................................................
19、...............................................................................147Homogeneitystudy..........................................................................................................................
20、...157.1Preamble..............................................................................................................................................157.2Materials................................................
21、..............................................................................................157.3Conceptofhomogeneity.....................................................................................................
22、...............167.4Practice................................................................................................................................................167.5Measurements...............................
23、......................................................................................................167.6Statisticallyvalidsamplingschemestrendanalysis...............................................................177.
24、7Evaluatingahomogeneitystudy.......................................................................................................177.8Betweenbottlehomogeneitystudy.......................................................
25、...........................................187.9Insufficientrepeatabilityofthemeasurementmethod...................................................................197.10Withinbottlehomogeneity.............................
26、...................................................................................198Stabilitystudy........................................................................................................................
27、.............208.1Typesof(in)stability...........................................................................................................................208.2Designsofexperiments..................................
28、...................................................................................218.3Evaluationofresults.................................................................................................................
29、..........228.4Stabilitymoniting............................................................................................................................258.5Determinationoftheshelflifeinrelationtothelongtermstability
30、..............................................279Determinationofthepropertyvalues...............................................................................................279.1General................................
31、.................................................................................................................279.2Establishingdemonstratingtraceability.................................................................
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