ASTM F1820-1997(2003) 测定模数碟状体设备轴向拆解力的标准试验方法
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【英文标准名称】:StandardTestMethodforDeterminingtheAxialDisassemblyForceofaModularAcetabularDevice
【原文标准名称】:测定模数碟状体设备轴向拆解力的标准试验方法
【标准号】:ASTMF1820-1997(2003)
【标准状态】:现行
【国别】:
【发布日期】:1997
【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】:碟状体成分;关节成形术;解体
【英文主题词】:acetabularcomponent;arthroplasty;disassembly
【摘要】:Thistestmethodisintendedtohelpassesstheaxiallockingstrengthoftheacetabularlinerinamodularshellwhensubjectedtoatensileloadingcondition.Additionalmeansofevaluatingthelockingmechanismsofmodularacetabulardevicesmaybeappropriatedependinguponthedesignofthedevice(thatis,lever-out,torsionalstrength,fatigue,andsoforth).Thistestmethodmaynotbeappropriateforallimplantapplications.Theuseriscautionedtoconsidertheappropriatenessofthemethodinviewofthematerialsanddesignbeingtestedandtheirpotentialapplication.Whilethistestmethodmaybeusedtomeasuretheforcerequiredtodisengagemodularacetabulardevices,comparisonofsuchdataforvariousdevicedesignsmusttakeintoconsiderationthesizeoftheimplantandthetypeoflockingmechanismevaluated.Thelocationofthelockingmechanismrelativetotheloadapplicationmaybedependentuponthesizeanddesignoftheacetabulardevice.Inaddition,thelockingmechanismitselfmayvarywithsize,particularlyifthedesigniscircumferentialinnature(forexample,largerdiameterimplantswouldhaveagreaterareaofacetabularshell/acetabularlinerinterfacethanasmalldiameterimplant).1.1Thistestmethodcoversastandardmethodologybywhichtomeasuretheattachmentstrengthbetweenthemodularacetabularshellandliner.Althoughthemethodologydescribeddoesnotreplicatephysiologicalloadingconditions,ithasbeendescribedasmeansofcomparingintegrityofvariouslockingmechanisms.1.2Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:J04
【国际标准分类号】:11_040_40
【页数】:3P.;A4
【正文语种】:
【原文标准名称】:测定模数碟状体设备轴向拆解力的标准试验方法
【标准号】:ASTMF1820-1997(2003)
【标准状态】:现行
【国别】:
【发布日期】:1997
【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】:碟状体成分;关节成形术;解体
【英文主题词】:acetabularcomponent;arthroplasty;disassembly
【摘要】:Thistestmethodisintendedtohelpassesstheaxiallockingstrengthoftheacetabularlinerinamodularshellwhensubjectedtoatensileloadingcondition.Additionalmeansofevaluatingthelockingmechanismsofmodularacetabulardevicesmaybeappropriatedependinguponthedesignofthedevice(thatis,lever-out,torsionalstrength,fatigue,andsoforth).Thistestmethodmaynotbeappropriateforallimplantapplications.Theuseriscautionedtoconsidertheappropriatenessofthemethodinviewofthematerialsanddesignbeingtestedandtheirpotentialapplication.Whilethistestmethodmaybeusedtomeasuretheforcerequiredtodisengagemodularacetabulardevices,comparisonofsuchdataforvariousdevicedesignsmusttakeintoconsiderationthesizeoftheimplantandthetypeoflockingmechanismevaluated.Thelocationofthelockingmechanismrelativetotheloadapplicationmaybedependentuponthesizeanddesignoftheacetabulardevice.Inaddition,thelockingmechanismitselfmayvarywithsize,particularlyifthedesigniscircumferentialinnature(forexample,largerdiameterimplantswouldhaveagreaterareaofacetabularshell/acetabularlinerinterfacethanasmalldiameterimplant).1.1Thistestmethodcoversastandardmethodologybywhichtomeasuretheattachmentstrengthbetweenthemodularacetabularshellandliner.Althoughthemethodologydescribeddoesnotreplicatephysiologicalloadingconditions,ithasbeendescribedasmeansofcomparingintegrityofvariouslockingmechanisms.1.2Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:J04
【国际标准分类号】:11_040_40
【页数】:3P.;A4
【正文语种】:
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