Designation:F2789−10(Reapproved2015)StandardGuideforMechanicalandFunctionalCharacterizationofNucleusDevices1ThisstandardisissuedunderthefixeddesignationF2789;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguidedescribesvariousformsofnucleusreplace-mentandnucleusaugmentationdevices.Itfurtheroutlinesthetypesoftestingthatarerecommendedinevaluatingtheperformanceofthesedevices.1.2Biocompatibilityofthematerialsusedinanucleusreplacementdeviceisnotaddressedinthisguide.However,usersshouldinvestigatethebiocompatibilityoftheirdeviceseparately(seeX1.1).1.3Whileitisunderstoodthatexpulsionandendplatefracturesrepresentdocumentedclinicalfailures,thisguidedoesnotspecificallyaddressthem,althoughsomeofthefactorsthatrelatetoexpulsionhavebeenincluded(seeX1.3).1.4Multipletestsaredescribedinthisguide;however,theuserneednotusethemall.Itistheresponsibilityoftheuserofthisguidetodeterminewhichtestsareappropriateforthedevicesbeingtestedandtheirpotentialapplication.Sometestsmaynotbeapplicableforalltypesofdevices.Moreover,somenucleusdevicesmaynotbestableinalltestconfigurations.However,thisdoesnotnecessarilymeanthatthetestmethodsdescribedareunsuitable.1.5Thescienceofnucleusdevicedesignisstillveryyoungandincludestechnologythatischangingmorequicklythanthisguidecanbemodified.Therefore,theusermustcarefullyconsidertheapplicabilityofthisguidetotheuser’sparticulardevice;theguidemaynotbeappropriateforeverydevice.Forexample,atthetimeofpublication,thisguidedoesnotaddressthenucleusreplacementandnucleusaugmentationdevicesthataredesignedtobepartiallyorcompletelyresorbableinthebody.However,someofthetestrecommendedinthisguidemaybeapplicabletoevaluatesuchdevices.Ithasnotbeendemonstratedthatmechanicalfailureofnucleusdevicesisrelatedtoadverseclinicalresults.Thereforethisstandardshouldbeuse...
