Designation:F2790−10(Reapproved2014)StandardPracticeforStaticandDynamicCharacterizationofMotionPreservingLumbarTotalFacetProstheses1ThisstandardisissuedunderthefixeddesignationF2790;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1ThispracticeprovidesguidanceforthestaticanddynamictestingofLumbarTotalFacetProstheses(FP).Theseimplantsareintendedtoallowmotionandlendsupporttooneormorefunctionalspinalunit(s)throughreplacementofthenaturalfacets.1.2Thesetestmethodsareintendedtoprovideabasisforthemechanicalcomparisonamongpast,present,andfuturenon-biologicFP.Thesetestmethodsallowcomparisonofdeviceswithdifferentmethodsofapplicationtothelumbarspine.Thesetestmethodsareintendedtoenabletheusertomechanicallycomparedevicesanddonotpurporttoprovideperformancestandardsforthem.1.3Thesetestmethodsdescribestaticanddynamictestsbyspecifyingloadtypesandspecificmethodsofapplyingtheseloads.1.4Thesetestmethodsdonotpurporttoaddressallclini-callyrelevantfailuremodesforFP,someofwhichwillbedevicespecific.Forexample,thesetestmethodsdonotaddressimplantwearresistanceunderexpectedinvivoloadsandmotions.Inaddition,thebiologicresponsetoweardebrisisnotaddressedinthesetestmethods.1.5Requirementsareestablishedformeasuringdisplace-mentsandevaluatingthestiffnessofFP.1.6Somedevicesmaynotbetestableinalltestconfigura-tions.1.7ThevaluesstatedinSIunitsaretoberegardedasthestandardwiththeexceptionofangularmeasurements,whichmaybereportedintermsofeitherdegreesorradians.1.8Thevaluesstatedininch-poundunitsaretoberegardedasstandard.ThevaluesgiveninparenthesesaremathematicalconversionstoSIunitsthatareprovidedforinformationonlyandarenotconsideredstandard.2.ReferencedDocuments2.1ASTMStandards:2D638TestMethodforTensilePropertiesofPlasticsE4PracticesforForceVerificationofTestingMachinesE6TerminologyRelatingt...
