Designation:F2423−11StandardGuideforFunctional,Kinematic,andWearAssessmentofTotalDiscProstheses1ThisstandardisissuedunderthefixeddesignationF2423;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguideprovidesguidanceforwearand/orfatiguetestingoftotaldiscprosthesesunderfunctionalandkinematicconditionsand,tothisend,describestestmethodsforassess-mentofthewearorfunctionalcharacteristics,orboth,oftotaldiscprostheses.1.2Bothlumbarandcervicalprosthesesareaddressed.1.3Loadandkinematicprofilesforlumbarandcervicaldevicesarenotidenticaland,therefore,areaddressedsepa-ratelyintheguide.1.4Partialdiscreplacements,suchasnucleusreplacementsorfacetjointreplacements,arenotintendedtobeaddressed.1.5Wearisassessedusingaweightlossmethodinatestingmediumasdefinedinthisguide.1.6Thisguidedoesnotaddressanypotentialfailuremodeasitrelatestothefixationoftheimplanttoitsbonyinterfaces.1.7Itistheintentofthisguidetoenablecomparisonofintervertebraldisc(IVD)prostheseswithregardtowearandfatiguecharacteristicswhentestedunderthespecifiedcondi-tions.Itmustberecognized,however,thattherearemanypossiblevariationsintheinvivoconditions.Asinglelaboratorysimulationwithafixedsetofparametersmightnotbeuniversallyrepresentative.1.8MostIVDprosthesesprimarilyfallintotwoclassifica-tions:articulatingball-in-sockettypeprostheses,andelasto-mericorcomplianttypeprostheses.Fortheformer,thisguideprimarilyaddressesMode1wear(definedherein);whereasforthelatter,thisguideaddressespotentialfailureoftheprosthesiswhentheimplantissubjectedtoarangeofmotionand/orloadsthatfallwithinthefullrangeofpossiblephysiologicmotionsandloads.1.9Forarticulatingcomponents,thisguidepredominantlydescribesaMode1test.Theuseriscautionedthatothermodesofwearmayoccurandmayhavesignificantinfluenceonthefunctionalityandperformanceofanarticul...
