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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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