ASTM F1800-2007 整体膝关节替代物的医疗胫骨盘部件的周期疲劳测试的标准试验方法
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【英文标准名称】:StandardTestMethodforCyclicFatigueTestingofMetalTibialTrayComponentsofTotalKneeJointReplacements
【原文标准名称】:整体膝关节替代物的医疗胫骨盘部件的周期疲劳测试的标准试验方法
【标准号】:ASTMF1800-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:关节造形术;元部件;疲劳测试;膝;医疗产品;金属;矫形外科学;修复装置;外科植入物;试验方法;总的
【英文主题词】:arthroplasty;orthopaedicmedicaldevices;tibialcomponents;totalkneearthroplasty
【摘要】:Thistestmethodcanbeusedtodescribetheeffectsofmaterials,manufacturing,anddesignvariablesonthefatigueperformanceofmetallictibialtrayssubjecttocyclicloadingforrelativelylargenumbersofcycles.Theloadingoftibialtraydesignsinvivowill,ingeneral,differfromtheloadingdefinedinthistestmethod.Theresultsobtainedherecannotbeusedtodirectlypredictinvivoperformance.However,thistestmethodisdesignedtoallowforcomparisonsbetweenthefatigueperformanceofdifferentmetallictibialtraydesigns,whentestedundersimilarconditions.Inorderforfatiguedataontibialtraystobecomparable,reproducible,andcapableofbeingcorrelatedamonglaboratories,itisessentialthatuniformproceduresbeestablished.1.1Thistestmethodcoversaprocedureforthefatiguetestingofmetallictibialtraysusedinkneejointreplacements.Thistestmethodcoverstheproceduresfortheperformanceoffatiguetestsonmetallictibialcomponentsusingacyclic,constant-amplitudeforce.Itappliestotibialtrayswhichcoverboththemedialandlateralplateausofthetibia.Thistestmethodmayrequiremodificationstoaccommodateothertibialtraydesigns.1.2Thistestmethodisintendedtoprovideuseful,consistent,andreproducibleinformationaboutthefatigueperformanceofmetallictibialtrayswithoneunsupportedcondyle.1.3ThevaluesstatedinSIunitsareregardedasthestandard.Theinch-poundunitsgiveninparenthesesareforinformationonly.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:6P.;A4
【正文语种】:
【原文标准名称】:整体膝关节替代物的医疗胫骨盘部件的周期疲劳测试的标准试验方法
【标准号】:ASTMF1800-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:关节造形术;元部件;疲劳测试;膝;医疗产品;金属;矫形外科学;修复装置;外科植入物;试验方法;总的
【英文主题词】:arthroplasty;orthopaedicmedicaldevices;tibialcomponents;totalkneearthroplasty
【摘要】:Thistestmethodcanbeusedtodescribetheeffectsofmaterials,manufacturing,anddesignvariablesonthefatigueperformanceofmetallictibialtrayssubjecttocyclicloadingforrelativelylargenumbersofcycles.Theloadingoftibialtraydesignsinvivowill,ingeneral,differfromtheloadingdefinedinthistestmethod.Theresultsobtainedherecannotbeusedtodirectlypredictinvivoperformance.However,thistestmethodisdesignedtoallowforcomparisonsbetweenthefatigueperformanceofdifferentmetallictibialtraydesigns,whentestedundersimilarconditions.Inorderforfatiguedataontibialtraystobecomparable,reproducible,andcapableofbeingcorrelatedamonglaboratories,itisessentialthatuniformproceduresbeestablished.1.1Thistestmethodcoversaprocedureforthefatiguetestingofmetallictibialtraysusedinkneejointreplacements.Thistestmethodcoverstheproceduresfortheperformanceoffatiguetestsonmetallictibialcomponentsusingacyclic,constant-amplitudeforce.Itappliestotibialtrayswhichcoverboththemedialandlateralplateausofthetibia.Thistestmethodmayrequiremodificationstoaccommodateothertibialtraydesigns.1.2Thistestmethodisintendedtoprovideuseful,consistent,andreproducibleinformationaboutthefatigueperformanceofmetallictibialtrayswithoneunsupportedcondyle.1.3ThevaluesstatedinSIunitsareregardedasthestandard.Theinch-poundunitsgiveninparenthesesareforinformationonly.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:6P.;A4
【正文语种】:
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