ASTM F2790-2010 活动腰椎全椎间盘假体的静态和动态特性用标准实施规程

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【英文标准名称】:StandardPracticeforStaticandDynamicCharacterizationofMotionPreservingLumbarTotalFacetProstheses
【原文标准名称】:活动腰椎全椎间盘假体的静态和动态特性用标准实施规程
【标准号】:ASTMF2790-2010
【标准状态】:现行
【国别】:
【发布日期】:2010
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.25
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:动态稳定性;动态试验;腰椎间盘关节造型术;臀部仪器;脊椎骨植入物;静态试验
【英文主题词】:dynamicstabilization;dynamictest;facetarthroplasty;posteriorinstrumentation;spinalimplants;statictest
【摘要】:FacetProsthesisComponents8212;Thefacetreplacementmaycompriseavarietyofshapesandconfigurations.Itsformsmayinclude,butarenotlimitedto,ballandsocketarticulatingjoints,jointshavingafree-floatingorsemi-constrainedthirdbody,metallicload-bearingsurfaces,andspringanddampeningmechanisms.Additionally,itmaybeaunilateralorbilateraldesign.ThesetestmethodsaredesignedtoquantifythestaticanddynamiccharacteristicsofdifferentdesignsofFP.Thetestsareconductedinvitroinordertoallowforanalysisofindividualdevicesandcomparisonofthemechanicalperformanceofmultipledesigns.TheloadsappliedtotheFPmaydifferfromthecomplexloadingseeninvivo,andtherefore,theresultsfromthesetestsmaynotdirectlypredictinvivoperformance.Theresults,however,canbeusedtocomparemechanicalperformanceindifferentdevices.Fatiguetestinginasimulatedbodyfluidorsalinemaycausefretting,corrosion,orlubricatetheinterconnectionsandtherebyaffecttherelativeperformanceoftesteddevices.Thistestshouldbeconductedina0.9%salineenvironmentalbathat37x00B0;Catamaximumrateof10Hzforallmetallicdevicesand2Hzfornon-metallicdevices.Othertestenvironmentssuchasasimulatedbodyfluid,asalinedripormist,distilledwater,othertypeoflubricationordrycouldalsobeusedwithadequatejustification.Likewise,alternativetestfrequenciesmaybeusedwithadequatejustificationtoensurethatitdoesnotimpactthedeviceperformance.Itiswellknownthatthefailureofmaterialsisdependentuponstress,testfrequency,surfacetreatments,andenvironmentalfactors.Therefore,whendeterminingtheeffectofchangingtheseparameters(forexample,frequency,material,orenvironment),careshouldbetakentoallowforappropriateinterpretationoftheresults.Inparticular,itmaybenecessarytoassesstheinfluenceoftestfrequencyondevicefracturewhileholdingthetestenvironment,implantmaterialsandprocessing,andimplantgeometryconstant.1.1ThispracticeprovidesguidanceforthestaticanddynamictestingofLumbarTotalFacetProstheses(FP).Theseimplantsareintendedtoallowmotionandlendsupporttooneormorefunctionalspinalunit(s)throughreplacementofthenaturalfacets.1.2Thesetestmethodsareintendedtoprovideabasisforthemechanicalcomparisonamongpast,present,andfuturenon-biologicFP.Thesetestmethodsallowcomparisonofdeviceswithdifferentmethodsofapplicationtothelumbarspine.Thesetestmethodsareintendedtoenabletheusertomechanicallycomparedevicesanddonotpurporttoprovideperformancestandardsforthem.1.3Thesetestmethodsdescribestaticanddynamictestsbyspecifyingloadtypesandspecificmethodsofapplyingtheseloads.1.4ThesetestmethodsdonotpurporttoaddressallclinicallyrelevantfailuremodesforFP,someofwhichwillbedevicespecific.Forexample,thesetestmethodsdonotaddressimplantwearresistanceunderexpectedinvivoloadsandmotions.Inaddition,thebiologicresponsetoweardebrisisnotaddressedinthesetestmethods.1.5RequirementsareestablishedformeasuringdisplacementsandevaluatingthestiffnessofFP.1.6Somedevicesmaynotbetestableinalltestconfigurations.1.7ThevaluesstatedinSIunitsaretoberegardedasthestandardwiththeexceptionofangularmeasurements,whichmaybereportedintermsofeitherdegreesorradians.1.8Thevaluesstatedininch-poundunitsar......
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:9P.;A4
【正文语种】: