ASTM F1612-1995(2005) 有转矩的金属带柄臀部关节成形术股骨元件的循环疲劳试验标准实施规程
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【英文标准名称】:StandardPracticeforCyclicFatigueTestingofMetallicStemmedHipArthroplastyFemoralComponentswithTorsion
【原文标准名称】:有转矩的金属带柄臀部关节成形术股骨元件的循环疲劳试验标准实施规程
【标准号】:ASTMF1612-1995(2005)
【标准状态】:现行
【国别】:
【发布日期】:1995
【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】:(Practice)
【标准水平】:()
【中文主题词】:循环疲劳试验;股骨元件;臀部关节成形术;关节成形术股骨元件;循环疲劳;使用;金属带柄臀部关节成形术股骨元件;实施规程;医疗器械;扭转试验
【英文主题词】:
【摘要】:Thispracticecanbeusedtodescribetheeffectsofmaterials,manufacturing,anddesignvariablesonthefatigueresistanceofmetallicstemmedfemoralcomponentssubjectedtocyclicloadingforrelativelylargenumbersofcycles.Therecommendedtestassumesaworstcasesituationinwhichproximalsupportforthestemhasbeenlost.Itisalsorecognizedthat,forsomematerials,theenvironmenthasaneffectontheresponsetocyclicloading(see12.7).Thetestenvironmentusedandrationaleforthechoiceofthatenvironmentshouldbedescribedinthetestreport.Itisrecognizedthatactualinvivoloadingconditionsarenotconstantamplitude.However,sufficientinformationisnotavailabletocreatestandardloadspectrumsformetallicstemmedfemoralcomponents.Asimpleperiodicconstantamplitudeforceisaccordinglyrecommended.1.1Thispracticecoversamethodforthefatiguetestingofmetallicstemmedfemoralcomponentsusedinhiparthroplasty.Thedescribedmethodisintendedtobeusedforevaluationincomparisonsofvariousdesignsandmaterialsusedforstemmedfemoralcomponentsusedinthearthroplasty.Thispracticecoversproceduresfortheperformanceoffatiguetestsusing(asaforcingfunction)aperiodicconstantamplitudeforce.1.2Thispracticeappliesprimarilytoone-pieceprosthesesandfemoralstemswithmodularheads,withtheheadinplace.Suchprosthesesshouldnothaveananterior-posteriorA-Pboworamedial-lateralM-Lbow,andtheyshouldhaveanearlystraightsectiononthedistal50mmofthestem.Thispracticemayrequiremodificationstoaccommodateotherfemoralstemdesigns.1.3ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40;77_040_10
【页数】:6P.;A4
【正文语种】:
【原文标准名称】:有转矩的金属带柄臀部关节成形术股骨元件的循环疲劳试验标准实施规程
【标准号】:ASTMF1612-1995(2005)
【标准状态】:现行
【国别】:
【发布日期】:1995
【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】:(Practice)
【标准水平】:()
【中文主题词】:循环疲劳试验;股骨元件;臀部关节成形术;关节成形术股骨元件;循环疲劳;使用;金属带柄臀部关节成形术股骨元件;实施规程;医疗器械;扭转试验
【英文主题词】:
【摘要】:Thispracticecanbeusedtodescribetheeffectsofmaterials,manufacturing,anddesignvariablesonthefatigueresistanceofmetallicstemmedfemoralcomponentssubjectedtocyclicloadingforrelativelylargenumbersofcycles.Therecommendedtestassumesaworstcasesituationinwhichproximalsupportforthestemhasbeenlost.Itisalsorecognizedthat,forsomematerials,theenvironmenthasaneffectontheresponsetocyclicloading(see12.7).Thetestenvironmentusedandrationaleforthechoiceofthatenvironmentshouldbedescribedinthetestreport.Itisrecognizedthatactualinvivoloadingconditionsarenotconstantamplitude.However,sufficientinformationisnotavailabletocreatestandardloadspectrumsformetallicstemmedfemoralcomponents.Asimpleperiodicconstantamplitudeforceisaccordinglyrecommended.1.1Thispracticecoversamethodforthefatiguetestingofmetallicstemmedfemoralcomponentsusedinhiparthroplasty.Thedescribedmethodisintendedtobeusedforevaluationincomparisonsofvariousdesignsandmaterialsusedforstemmedfemoralcomponentsusedinthearthroplasty.Thispracticecoversproceduresfortheperformanceoffatiguetestsusing(asaforcingfunction)aperiodicconstantamplitudeforce.1.2Thispracticeappliesprimarilytoone-pieceprosthesesandfemoralstemswithmodularheads,withtheheadinplace.Suchprosthesesshouldnothaveananterior-posteriorA-Pboworamedial-lateralM-Lbow,andtheyshouldhaveanearlystraightsectiononthedistal50mmofthestem.Thispracticemayrequiremodificationstoaccommodateotherfemoralstemdesigns.1.3ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40;77_040_10
【页数】:6P.;A4
【正文语种】:
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