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1、?ISO2018Biologicalevaluationofmedicaldevices—Part1:Evaluationtestingwithinariskmanagementprocessvaluationbiologiquedesdispositifsmdicaux—Partie1:valuationetessaisauseindunprocessusdegestiondurisqueINTERNATIONALSTARDISO10

2、9931Fifthedition201808ReferencenumberISO109931:2018(E)CopyrightInternationalganizationfStardizationProvidedbyIHSMarkitunderlicensewithANSINotfResale0820201820:10:24MDTNoreproductionwkingpermittedwithoutlicensefromIHS````

3、``````````````````ISO109931:2018(E)Fewd.....................................................................................................................................................................................

4、...................................................ivIntroduction...........................................................................................................................................................

5、.......................................................................v1Scope..............................................................................................................................................

6、...................................................................................12Nmativereferences......................................................................................................................

7、...............................................................13Termsdefinitions...........................................................................................................................................

8、..........................................24Generalprinciplesapplyingtobiologicalevaluationofmedicaldevices.................................................55Categizationofmedicaldevices..................................

9、....................................................................................................................95.1General.............................................................................................

10、..............................................................................................................95.2Categizationbynatureofbodycontact.........................................................................

11、...............................................95.2.1Noncontactingmedicaldevices.........................................................................................................................95.2.2Surfacecontac

12、tingmedicaldevices.............................................................................................................105.2.3Externallycommunicatingmedicaldevices.................................................

13、.........................................105.2.4Implantmedicaldevices.........................................................................................................................................115.3Categizat

14、ionbydurationofcontact.............................................................................................................................115.3.1Contactdurationcategies...........................................

15、.....................................................................................115.3.2Transitycontactingmedicaldevices................................................................................................

16、.....115.3.3Medicaldeviceswithmultiplecontactdurationcategies....................................................116Biologicalevaluationprocess.............................................................................

17、.................................................................................126.1Physicalchemicalinfmationfbiologicalriskanalysis.................................................................126.2Gapanalysisionof

18、biologicalendpointsfassessment.......................................................126.3Biologicaltesting.................................................................................................................

19、...............................................................136.3.1General...............................................................................................................................................

20、....................................136.3.2Testingfevaluation...............................................................................................................................................147Interpretatio

21、nofbiologicalevaluationdataoverallbiologicalriskassessment...............18AnnexA(infmative)Endpointstobeaddressedinabiologicalriskassessment.........................................20AnnexB(infmative)Guidanceontheconduc

22、tofbiologicalevaluationwithinariskmanagementprocess.........................................................................................................................................................................

23、...........25AnnexC(infmative)Suggestedprocedurefliteraturereview...................................................................................38Bibliography..........................................................

24、...................................................................................................................................................................40?ISO2018–AllrightsreservediiiContentsPageCopyrightInter

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