ASTM F543-2007 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】:ASTMF543-2007
【标准状态】:现行
【国别】:
【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】:骨螺钉;医疗设备;医学科学;螺钉;规范(验收)
【英文主题词】:bonescrew;dimensions;insertion;performancerequirements;pullout;static;testmethods;torsion
【摘要】:1.1Thisspecificationprovidesrequirementsformaterials,finishandmarking,careandhandling,andtheacceptabledimensionsandtolerancesformetallicbonescrewsthatareimplantedintobone.Thedimensionsandtolerancesinthisspecificationareapplicableonlytometallicbonescrewsdescribedinthisspecification.1.2Thisspecificationprovidesperformanceconsiderationsandstandardtestmethodsformeasuringmechanicalpropertiesintorsionofmetallicbonescrewsthatareimplantedintobone.Thesetestmethodsmayalsobeapplicabletootherscrewsbesidesthosewhosedimensionsandtolerancesarespecifiedhere.Thefollowingannexesareincluded:1.2.1AnnexA1-TestMethodforDeterminingtheTorsionalPropertiesofMetallicBoneScrews.1.2.2AnnexA2-TestMethodforDrivingTorqueofMedicalBoneScrews.1.2.3AnnexA3-TestMethodforDeterminingtheAxialPulloutStrengthofMedicalBoneScrews.1.2.4AnnexA4-TestMethodforDeterminingtheSelf-TappingPerformanceofSelf-TappingMedicalBoneScrews.1.2.5AnnexA5-SpecificationsforTypeHAandTypeHBMetallicBoneScrews.1.2.6AnnexA6-SpecificationsforTypeHCandTypeHDMetallicBoneScrews.1.2.7AnnexA7-SpecificationsforMetallicBoneScrewDriveConnections.1.3Thisspecificationisbased,inpart,uponISO5835,ISO6475,andISO9268.1.4Unlessotherwiseindicated,thevaluesstatedinSIunitsaretoberegardedasstandard.Thevaluesinparenthesesaregivenforinformationonly.Thisstandardmayinvolvetheuseofhazardousmaterials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.1.5Thisannexspecifiestherequirementsforavarietyofdriveconnectionsthatcanbeimplementedinmetallicmedicalbonescrews.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】:
【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】:ASTMF543-2007
【标准状态】:现行
【国别】:
【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】:骨螺钉;医疗设备;医学科学;螺钉;规范(验收)
【英文主题词】:bonescrew;dimensions;insertion;performancerequirements;pullout;static;testmethods;torsion
【摘要】:1.1Thisspecificationprovidesrequirementsformaterials,finishandmarking,careandhandling,andtheacceptabledimensionsandtolerancesformetallicbonescrewsthatareimplantedintobone.Thedimensionsandtolerancesinthisspecificationareapplicableonlytometallicbonescrewsdescribedinthisspecification.1.2Thisspecificationprovidesperformanceconsiderationsandstandardtestmethodsformeasuringmechanicalpropertiesintorsionofmetallicbonescrewsthatareimplantedintobone.Thesetestmethodsmayalsobeapplicabletootherscrewsbesidesthosewhosedimensionsandtolerancesarespecifiedhere.Thefollowingannexesareincluded:1.2.1AnnexA1-TestMethodforDeterminingtheTorsionalPropertiesofMetallicBoneScrews.1.2.2AnnexA2-TestMethodforDrivingTorqueofMedicalBoneScrews.1.2.3AnnexA3-TestMethodforDeterminingtheAxialPulloutStrengthofMedicalBoneScrews.1.2.4AnnexA4-TestMethodforDeterminingtheSelf-TappingPerformanceofSelf-TappingMedicalBoneScrews.1.2.5AnnexA5-SpecificationsforTypeHAandTypeHBMetallicBoneScrews.1.2.6AnnexA6-SpecificationsforTypeHCandTypeHDMetallicBoneScrews.1.2.7AnnexA7-SpecificationsforMetallicBoneScrewDriveConnections.1.3Thisspecificationisbased,inpart,uponISO5835,ISO6475,andISO9268.1.4Unlessotherwiseindicated,thevaluesstatedinSIunitsaretoberegardedasstandard.Thevaluesinparenthesesaregivenforinformationonly.Thisstandardmayinvolvetheuseofhazardousmaterials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.1.5Thisannexspecifiestherequirementsforavarietyofdriveconnectionsthatcanbeimplementedinmetallicmedicalbonescrews.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】:
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