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1、?ISO2013Sterilizationofhealthcareproducts—Radiation—Part2:EstablishingthesterilizationdoseStrilisationdesproduitsdesant—Irradiation—Partie2:tablissementdeladosestrilisanteINTERNATIONALSTARDISO111372Thirdedition20130601Re

2、ferencenumberISO111372:2013(E)ISO111372:2013(E)?ISO2013–AllrightsreservediiiContentsPageFewd................................................................................................................................

3、..........................................................................................................vIntroduction.....................................................................................................

4、...........................................................................................................................vi1Scope.........................................................................................

5、........................................................................................................................................12Nmativereferences.................................................................

6、.....................................................................................................................13Termsdefinitionsabbreviatedterms.....................................................................

7、..........................................................13.1Termsdefinitions..............................................................................................................................................

8、.........................13.2Abbreviatedterms...............................................................................................................................................................................

9、34Definitionmaintenanceofproductfamiliesfdosesettingdosesubstantiationsterilizationdoseauditing.............................................................................................................................

10、............................................44.1General.....................................................................................................................................................................

11、......................................44.2Definingproductfamilies...........................................................................................................................................................

12、...44.3Designationofproducttorepresentaproductfamilyfperfmanceofaverificationdoseexperimentsterilizationdoseaudit...........................................................................................................

13、.......54.4Maintainingproductfamilies.....................................................................................................................................................64.5Effectoffailureofestablishment

14、ofsterilizationdoseofasterilizationdoseauditonaproductfamily................................................................................................................................................................

15、..........................75iontestingofproductfestablishingthesterilizationdose...................................................75.1Natureofproduct......................................................................

16、...........................................................................................................75.2Sampleitemption(SIP).........................................................................................

17、....................................................................85.3Mannerofsampling....................................................................................................................................

18、........................................95.4Microbiologicaltesting..........................................................................................................................................................

19、...........95.5Irradiation..................................................................................................................................................................................................

20、.96Methodsofdoseestablishment............................................................................................................................................................97Method1:dosesettingusingbioburden

21、infmation................................................................................................107.1Rationale.....................................................................................................

22、...............................................................................................107.2ProcedurefMethod1fproductwithanaveragebioburdengreaterthanequalto10fmultipleproductionbatches...........................

23、.................................................................................................117.3ProcedurefMethod1fproductwithanaveragebioburdengreaterthanequalto10fasingleproductionbatch............................

24、.......................................................................................................177.4ProcedurefMethod1fproductwithanaveragebioburdenintherange01to09fmultiplesingleproductionbatches.................

25、............................................................................................................198Method2:Dosesettingusingfractionpositiveinfmationfromincrementaldosingtodetermineanextrapolationfact.........

26、........................................................................................................................................208.1Rationale......................................................................

27、..............................................................................................................................208.2ProcedurefMethod2A.......................................................................

28、.....................................................................................218.3ProcedurefMethod2B................................................................................................................

29、............................................249MethodVDmax—Substantiationof25kGy15kGyasthesterilizationdose.............................289.1Rationale......................................................................

30、..............................................................................................................................289.2ProcedurefMethodVDmax25fmultipleproductionbatches........................................

31、...................299.3ProcedurefMethodVDmax25fasingleproductionbatch...................................................................349.4ProcedurefMethodVDmax15fmultipleproductionbatches.............................

32、..............................379.5ProcedurefMethodVDmax15fasingleproductionbatch...................................................................4010Sterilizationdoseaudit..............................................

33、.................................................................................................................................4310.1Purposefrequency.....................................................................

34、............................................................................................4310.2ProcedurefauditingasterilizationdoseestablishedusingMethod1Method2AMethod2B...............................................

35、.................................................................................................................................................4310.3ProcedurefauditingasterilizationdosesubstantiatedusingMethodVDmax25Me

36、thodVDmax15..................................................................................................................................................................................4610.4Failureofasterilizationdo

37、seaudit....................................................................................................................................5211Wkedexamples.................................................................

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