ASTM F543-2007e1 金属医疗骨螺钉的标准规范和试验方法
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【英文标准名称】:StandardSpecificationandTestMethodsforMetallicMedicalBoneScrews
【原文标准名称】:金属医疗骨螺钉的标准规范和试验方法
【标准号】:ASTMF543-2007e1
【标准状态】:现行
【国别】:美国
【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】:F04.21
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:bonescrew;dimensions;insertion;performancerequirements;pullout;static;testmethods;torsion;Corticalbonescrews;Metallicsurgicalimplantmaterials--specifications;Orthopaedicmedicaldevices--specifications;Orthopaedicmedicaldevices(bone)
【摘要】:A1.1.1Thistestmethodisusedtomeasurethetorsionalyieldstrength,maximumtorque,andbreakingangleofthebonescrewunderstandardconditions.Theresultsobtainedinthistestmethodarenotintendedtopredictthetorqueencounteredwhileinsertingorremovingabonescrewinhumanoranimalbone.Thistestmethodisintendedonlytomeasuretheuniformityoftheproducttestedortocomparethemechanicalpropertiesofdifferent,yetsimilarlysized,products.1.1Thisspecificationprovidesrequirementsformaterials,finishandmarking,careandhandling,andtheacceptabledimensionsandtolerancesformetallicbonescrewsthatareimplantedintobone.Thedimensionsandtolerancesinthisspecificationareapplicableonlytometallicbonescrewsdescribedinthisspecification.1.2Thisspecificationprovidesperformanceconsiderationsandstandardtestmethodsformeasuringmechanicalpropertiesintorsionofmetallicbonescrewsthatareimplantedintobone.Thesetestmethodsmayalsobeapplicabletootherscrewsbesidesthosewhosedimensionsandtolerancesarespecifiedhere.Thefollowingannexesareincluded:1.2.1AnnexA1x2014;TestMethodforDeterminingtheTorsionalPropertiesofMetallicBoneScrews.1.2.2AnnexA2x2014;TestMethodforDrivingTorqueofMedicalBoneScrews.1.2.3AnnexA3x2014;TestMethodforDeterminingtheAxialPulloutStrengthofMedicalBoneScrews.1.2.4AnnexA4x2014;TestMethodforDeterminingtheSelf-TappingPerformanceofSelf-TappingMedicalBoneScrews.1.2.5AnnexA5x2014;SpecificationsforTypeHAandTypeHBMetallicBoneScrews.1.2.6AnnexA6x2014;SpecificationsforTypeHCandTypeHDMetallicBoneScrews.1.2.7AnnexA7x2014;SpecificationsforMetallicBoneScrewDriveConnections.1.3Thisspecificationisbased,inpart,uponISO5835,ISO6475,andISO9268.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandardmayinvolvetheuseofhazardousmaterials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.A7.1.1Thisannexspecifiestherequirementsforavarietyofdriveconnectionsthatcanbeimplementedinmetallicmedicalbonescrews.Thescrew''sdriveconnectionsuppliestheinterconnectionthatistypicallyusedinorthopedicsurgeryforinsertingandremovingbonescrews.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:20P.;A4
【正文语种】:英语
【原文标准名称】:金属医疗骨螺钉的标准规范和试验方法
【标准号】:ASTMF543-2007e1
【标准状态】:现行
【国别】:美国
【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】:F04.21
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:bonescrew;dimensions;insertion;performancerequirements;pullout;static;testmethods;torsion;Corticalbonescrews;Metallicsurgicalimplantmaterials--specifications;Orthopaedicmedicaldevices--specifications;Orthopaedicmedicaldevices(bone)
【摘要】:A1.1.1Thistestmethodisusedtomeasurethetorsionalyieldstrength,maximumtorque,andbreakingangleofthebonescrewunderstandardconditions.Theresultsobtainedinthistestmethodarenotintendedtopredictthetorqueencounteredwhileinsertingorremovingabonescrewinhumanoranimalbone.Thistestmethodisintendedonlytomeasuretheuniformityoftheproducttestedortocomparethemechanicalpropertiesofdifferent,yetsimilarlysized,products.1.1Thisspecificationprovidesrequirementsformaterials,finishandmarking,careandhandling,andtheacceptabledimensionsandtolerancesformetallicbonescrewsthatareimplantedintobone.Thedimensionsandtolerancesinthisspecificationareapplicableonlytometallicbonescrewsdescribedinthisspecification.1.2Thisspecificationprovidesperformanceconsiderationsandstandardtestmethodsformeasuringmechanicalpropertiesintorsionofmetallicbonescrewsthatareimplantedintobone.Thesetestmethodsmayalsobeapplicabletootherscrewsbesidesthosewhosedimensionsandtolerancesarespecifiedhere.Thefollowingannexesareincluded:1.2.1AnnexA1x2014;TestMethodforDeterminingtheTorsionalPropertiesofMetallicBoneScrews.1.2.2AnnexA2x2014;TestMethodforDrivingTorqueofMedicalBoneScrews.1.2.3AnnexA3x2014;TestMethodforDeterminingtheAxialPulloutStrengthofMedicalBoneScrews.1.2.4AnnexA4x2014;TestMethodforDeterminingtheSelf-TappingPerformanceofSelf-TappingMedicalBoneScrews.1.2.5AnnexA5x2014;SpecificationsforTypeHAandTypeHBMetallicBoneScrews.1.2.6AnnexA6x2014;SpecificationsforTypeHCandTypeHDMetallicBoneScrews.1.2.7AnnexA7x2014;SpecificationsforMetallicBoneScrewDriveConnections.1.3Thisspecificationisbased,inpart,uponISO5835,ISO6475,andISO9268.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandardmayinvolvetheuseofhazardousmaterials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.A7.1.1Thisannexspecifiestherequirementsforavarietyofdriveconnectionsthatcanbeimplementedinmetallicmedicalbonescrews.Thescrew''sdriveconnectionsuppliestheinterconnectionthatistypicallyusedinorthopedicsurgeryforinsertingandremovingbonescrews.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:20P.;A4
【正文语种】:英语
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