ASTM F2722-2008 评价活动衬垫膝关节胫骨基座旋转档位的标准试验方法

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【英文标准名称】:StandardTestMethodforEvaluatingMobileBearingKneeTibialBaseplateRotationalStops
【原文标准名称】:评价活动衬垫膝关节胫骨基座旋转档位的标准试验方法
【标准号】:ASTMF2722-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:F04.22
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:Arthroplasty;Kneereplacementprosthesis;Medicaldevices/equipment;Surgicalimplants
【摘要】:Fundamentalaspectsofthistestmethodincludetheuseofdynamicrotationalforceandmotionrepresentativeofthehumankneejointduringanactivityofdailyliving(deepflexion)andtheeffectoftheseforcesandmotionsonthedesignfeatureswhichstoporlimitrotationinamobilebearingkneedesign.Thistestisrequiredifrotationalstopsaredesignedtolimitmotiontox00B1;20x00B0;orless;orthereareotherresistancestorotationalmotionwiththisx00B1;20x00B0;range.Insomeinstances,therotationaldisplacementcouldoccurinboththeinferiorandsuperiorinterfaces.1.1Thistestmethodcoversalaboratory-basedinvitromethodforevaluatingthemechanicalperformanceofmaterialsanddevicesbeingconsideredforreplacementofthetibio-femoraljointinhumankneejointreplacementprosthesesinmobilebearingkneesystems.1.2Mobilebearingkneesystemspermitinternalexternalrotationtotakeplaceononeorbotharticulatingsurfaces.Somedesignsplacephysicallimitsorstopstotheamountofrotation.Otherdesignsmayhaveincreasesofaresistanceforcewithincreasesinrotation.1.3Althoughthemethodologydescribesattemptstoidentifyphysiologicallyrelevantmotionsandforceconditions,theinterpretationofresultsislimitedtoaninvitrocomparisonbetweenmobilebearingkneedesignsandtheirabilitytomaintaintheintegrityoftherotationalstopfeatureandtibialbearingcomponentunderthestatedtestconditions.1.4Thistestmethodisonlyapplicabletomobilekneetibialsystemswitharotationalstop.1.5ThevaluesstatedinSIunitsareregardedasstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】:英语