ASTM F2580-2009 最接近固定股骨髋假体标准接头的评估用标准试验方法
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【英文标准名称】:StandardTestMethodforEvaluationofModularConnectionofProximallyFixedFemoralHipProsthesis
【原文标准名称】:最接近固定股骨髋假体标准接头的评估用标准试验方法
【标准号】:ASTMF2580-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【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;femoralhipprostheses;orthopedicmedicaldevices;proximalfixation;totalhiparthroplasty;Arthroplasty;Femoralsurgicalcomponents;Hipreplacementprosthesis;Prostheses
【摘要】:Thistestmethodcanbeusedtodescribetheeffectsofmaterials,manufacturing,anddesignvariablesonthefatigueperformanceofmetallicfemoralhipprosthesessubjecttocyclicloadingforlargenumbersofcycles.Theloadingoffemoralhipdesignsinvivowill,ingeneral,differfromtheloadingdefinedinthistestmethod.Theresultsobtainedherecannotbeusedtodirectlypredictinvivoperformance.However,thistestmethodisdesignedtoallowforcomparisonsbetweenthefatigueperformanceofdifferentmetallicfemoralhipdesigns,whentestedundersimilarconditions.Inorderforfatiguedataonfemoralhipprosthesestobecomparable,reproducible,andcapableofbeingcorrelatedamonglaboratories,itisessentialthatuniformproceduresbeestablished.1.1Thistestmethodcoversaprocedureforthefatiguetestingofmetallicfemoralhipprosthesesusedinhipjointreplacements.Thistestmethodcoverstheproceduresfortheperformanceoffatiguetestsonmetallicfemoralhipstemsusingacyclic,constant-amplitudeforce.Itappliestohipprosthesesthatutilizeproximalmetaphysealfixationandareofamodularconstruct,anditisintendedtoevaluatethefatigueperformanceofthemodularconnectionsinthemetaphysealfilling(thatis,proximalbody)regionofthestem.1.2Thistestmethodisintendedtoprovideuseful,consistent,andreproducibleinformationaboutthefatigueperformanceofmetallichipprostheseswhileheldinaproximallyfixatedmanner,withthedistalendnotheldbyapottingmedium.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:英语
【原文标准名称】:最接近固定股骨髋假体标准接头的评估用标准试验方法
【标准号】:ASTMF2580-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【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;femoralhipprostheses;orthopedicmedicaldevices;proximalfixation;totalhiparthroplasty;Arthroplasty;Femoralsurgicalcomponents;Hipreplacementprosthesis;Prostheses
【摘要】:Thistestmethodcanbeusedtodescribetheeffectsofmaterials,manufacturing,anddesignvariablesonthefatigueperformanceofmetallicfemoralhipprosthesessubjecttocyclicloadingforlargenumbersofcycles.Theloadingoffemoralhipdesignsinvivowill,ingeneral,differfromtheloadingdefinedinthistestmethod.Theresultsobtainedherecannotbeusedtodirectlypredictinvivoperformance.However,thistestmethodisdesignedtoallowforcomparisonsbetweenthefatigueperformanceofdifferentmetallicfemoralhipdesigns,whentestedundersimilarconditions.Inorderforfatiguedataonfemoralhipprosthesestobecomparable,reproducible,andcapableofbeingcorrelatedamonglaboratories,itisessentialthatuniformproceduresbeestablished.1.1Thistestmethodcoversaprocedureforthefatiguetestingofmetallicfemoralhipprosthesesusedinhipjointreplacements.Thistestmethodcoverstheproceduresfortheperformanceoffatiguetestsonmetallicfemoralhipstemsusingacyclic,constant-amplitudeforce.Itappliestohipprosthesesthatutilizeproximalmetaphysealfixationandareofamodularconstruct,anditisintendedtoevaluatethefatigueperformanceofthemodularconnectionsinthemetaphysealfilling(thatis,proximalbody)regionofthestem.1.2Thistestmethodisintendedtoprovideuseful,consistent,andreproducibleinformationaboutthefatigueperformanceofmetallichipprostheseswhileheldinaproximallyfixatedmanner,withthedistalendnotheldbyapottingmedium.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:英语
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