ASTM F564-2010 金属骨科U形钉标准规范和试验方法

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【英文标准名称】:StandardSpecificationandTestMethodsforMetallicBoneStaples
【原文标准名称】:金属骨科U形钉标准规范和试验方法
【标准号】:ASTMF564-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010
【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】:F04.21
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:bendingtest;bonefixation;fatiguetest;fixationdevices;metallicbonestaples;orthopaedicmedicaldevices;pullouttest;softtissuefixation;surgicalimplants;Boneimplantmaterials/applications--specifications;Constantamplitudebendingfatigu
【摘要】:A1.3.1Thistestmethodisusedtodeterminethefatigueresistanceofmetallicbonestapleswhensubjectedtorepetitiveloadingforlargenumbersofcycles.Thisinformationmayalsobeusefulforcomparingtheeffectofvariationsinstaplematerial,geometry,surfacecondition,orplacementundercertaincircumstances.A1.3.2Itisessentialthatuniformfatiguepracticesbeestablishedinorderthatsuchbasicfatiguedatabecomparableandreproducibleandcanbecorrelatedamonglaboratories.A1.3.3Theresultsoffatiguetestsaresuitablefordirectapplicationtodesignonlywhentheserviceconditionsparallelthetestconditionsexactly.Thistestmethodmaynotbeappropriateforalltypesofbonestapleapplications.Theuseriscautionedtoconsidertheappropriatenessofthetestmethodinviewofthematerialsbeingtestedandtheirpotentialapplication.1.1Thisspecificationcoverscharacterizationofthedesignandmechanicalfunctionofmetallicstaplesusedintheinternalfixationofthemuscularskeletalsystem.Itisnottheintentionofthisspecificationtodescribeorspecifyspecificdesignsformetallicbonestaples.1.2Thisspecificationincludesthefollowingfourtestmethodsformeasuringmechanicalpropertiesofmetallicbonestaples:1.2.1TestMethodforConstantAmplitudeBendingFatigueTestsofMetallicBoneStaplesAnnexA1.1.2.2TestMethodforPull-OutFixationStrengthofMetallicBoneStaplesAnnexA2.1.2.3TestMethodforSoftTissueFixationStrengthofMetallicBoneStaplesAnnexA3.1.2.4TestMethodforElasticStaticBendingofMetallicBoneStaplesAnnexA4.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.A1.1.1Thistestmethodcoversproceduresfortheperformanceofconstantamplitudefatiguetestingofmetallicstaplesusedininternalfixationofthemusculoskeletalsystem.Thistestmethodmaybeusedwhentestinginairatambienttemperatureorinanaqueousorphysiologicalsolution.A1.1.2ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.A1.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.A2.1.1Thistestmethodcoverstestingofthehardtissuepull-outfixationstrengthofmetallicstaplesusedintheinternalfixationofthemusculoskeletalsystem.Thistestmethodmaybeusedwithphysiologicboneorasyntheticsubstitute.Itmayalsobeusedwhentestinginanaqueousorphysiologicalsolution.A2.1.2ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.A2.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.......
【中国标准分类号】:C45
【国际标准分类号】:11_040_30
【页数】:12P.;A4
【正文语种】:英语