ASTM F1829-1998(2003) 静态评价剪切中关节窝锁紧结构的标准试验方法
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【英文标准名称】:StandardTestMethodforStaticEvaluationoftheGlenoidLockingMechanisminShear
【原文标准名称】:静态评价剪切中关节窝锁紧结构的标准试验方法
【标准号】:ASTMF1829-1998(2003)
【标准状态】:现行
【国别】:
【发布日期】:1998
【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】:模数;整形外科医疗设备;关节窝;肩关节成形术;关节成形术;解体
【英文主题词】:arthroplasty;disassembly;glenoid;modular;orthopaedicmedicaldevices;shoulderarthroplasty
【摘要】:Thistestmethodcanbeusedtodescribetheeffectsofmaterials,manufacturing,anddesignvariablesontheperformanceofmetalbackedglenoidprostheseslockingmechanismstoresiststaticshearloading.TheglenoidcomponentisusedinshoulderreplacementsandshouldconformtothecriteriaspecifiedinSpecificationF1378.Theloadingofmetalbackedglenoidprosthesesinvivowill,ingeneral,differfromtheloadingdefinedinthistestmethod.Theresultsobtainedherecannotbeusedtodirectlypredictinvivoperformance.However,thistestmethodisdesignedtoallowforcomparisonsbetweendifferentmetalbackedglenoidlockingmechanismdesigns,whentestedundersimilarcircumstances.Thistestmethodmaynotbeappropriateforalltypesofimplantapplications.Theuseriscautionedtoconsidertheappropriatenessofthemethodinviewofthematerialsbeingtestedandtheirpotentialapplication.Inorderforthetestdataonmetalbackedglenoidcomponentstobecomparable,reproducible,andcapableofbeingcorrelatedamonglaboratories,itisessentialthatuniformproceduresbeestablished.1.1Thistestmethodcoversamethodfordeterminingthestaticsheardisassemblyforceofmodularglenoidcomponentsusedinshoulderprostheses.Itisintendedtobeusedasadesignvalidationandforcomparisonwithotherprostheses.1.2Thistestmethodcoversmodularglenoidcomponentscomprisedofaseparatearticularinsertandbacking.Theinsertandbackingcanbefabricatedfromanycombinationofthefollowingmaterials:metalalloys,polymericmaterials,compositematerials.1.3ThevaluesstatedinSIunitsareregardedasthestandard.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】:4P.;A4
【正文语种】:
【原文标准名称】:静态评价剪切中关节窝锁紧结构的标准试验方法
【标准号】:ASTMF1829-1998(2003)
【标准状态】:现行
【国别】:
【发布日期】:1998
【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】:模数;整形外科医疗设备;关节窝;肩关节成形术;关节成形术;解体
【英文主题词】:arthroplasty;disassembly;glenoid;modular;orthopaedicmedicaldevices;shoulderarthroplasty
【摘要】:Thistestmethodcanbeusedtodescribetheeffectsofmaterials,manufacturing,anddesignvariablesontheperformanceofmetalbackedglenoidprostheseslockingmechanismstoresiststaticshearloading.TheglenoidcomponentisusedinshoulderreplacementsandshouldconformtothecriteriaspecifiedinSpecificationF1378.Theloadingofmetalbackedglenoidprosthesesinvivowill,ingeneral,differfromtheloadingdefinedinthistestmethod.Theresultsobtainedherecannotbeusedtodirectlypredictinvivoperformance.However,thistestmethodisdesignedtoallowforcomparisonsbetweendifferentmetalbackedglenoidlockingmechanismdesigns,whentestedundersimilarcircumstances.Thistestmethodmaynotbeappropriateforalltypesofimplantapplications.Theuseriscautionedtoconsidertheappropriatenessofthemethodinviewofthematerialsbeingtestedandtheirpotentialapplication.Inorderforthetestdataonmetalbackedglenoidcomponentstobecomparable,reproducible,andcapableofbeingcorrelatedamonglaboratories,itisessentialthatuniformproceduresbeestablished.1.1Thistestmethodcoversamethodfordeterminingthestaticsheardisassemblyforceofmodularglenoidcomponentsusedinshoulderprostheses.Itisintendedtobeusedasadesignvalidationandforcomparisonwithotherprostheses.1.2Thistestmethodcoversmodularglenoidcomponentscomprisedofaseparatearticularinsertandbacking.Theinsertandbackingcanbefabricatedfromanycombinationofthefollowingmaterials:metalalloys,polymericmaterials,compositematerials.1.3ThevaluesstatedinSIunitsareregardedasthestandard.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】:4P.;A4
【正文语种】:
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