ASTM F382-1999(2003)e1 金属骨板的静态弯曲特性的测试方法和标准规范
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【英文标准名称】:StandardSpecificationandTestMethodforMetallicBonePlates
【原文标准名称】:金属骨板的静态弯曲特性的测试方法和标准规范
【标准号】:ASTMF382-1999(2003)e1
【标准状态】:现行
【国别】:
【发布日期】:1999
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.21
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:骨板;试验;医疗设备;金属;医学科学;板
【英文主题词】:bendtesting-surgicalimplants;fatiguetest;boneplate;orthopedicmedicaldevices-boneplates;surgicaldevices;testmethods-surgicalimplants;
【摘要】:1.1Thisspecificationandtestmethodisintendedtoprovideacomprehensivereferenceforboneplatesusedinthesurgicalinternalfixationoftheskeletalsystem.Thestandardestablishesconsistentmethodstoclassify,definethegeometriccharacteristics,andperformancecharacteristicsofboneplates.Thestandardalsopresentsacatalogofstandardspecificationsthatspecifymaterial;labelingandhandlingrequirements;andstandardtestmethodsformeasuringperformancerelatedmechanicalcharacteristicsdeterminedtobeimportanttotheinvivoperformanceofboneplates.1.2Itisnottheintentionofthestandardtodefinelevelsofperformanceorcase-specificclinicalperformanceforboneplates,asinsufficientknowledgeisavailabletopredicttheconsequencesortheiruseinindividualpatientsforspecificactivitiesofdailyliving.Futhermore,itisnottheintentionofthestandardtodescribeorspecifyspecificdesignsforboneplatesusedinthesurgicalinternalfixationoftheskeletalsystem.1.3Thisstandardmaynotbeappropriateforalltypesofboneplates.Theuseriscautionedtoconsidertheappropriatenessofthestandardinviewofaparticularboneplateanditspotentialapplication.1.4Thisstandardincludesthefollowingtestmethodsusedindeterminingthefollowingboneplatemechanicalperformancecharacteristics.1.4.1StandardTestMethodforSingleCycleBendTestingofMetallicBonePlates-AnnexA1.1.4.2StandardTestMethodforDeterminingtheBendingFatiguePropertiesOfMetallicBonePlates-AnnexA2.1.5Unlessotherwiseindicated,thevaluesstatedinSIunitsshallberegardedasthestandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:12P.;A4
【正文语种】:
【原文标准名称】:金属骨板的静态弯曲特性的测试方法和标准规范
【标准号】:ASTMF382-1999(2003)e1
【标准状态】:现行
【国别】:
【发布日期】:1999
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.21
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:骨板;试验;医疗设备;金属;医学科学;板
【英文主题词】:bendtesting-surgicalimplants;fatiguetest;boneplate;orthopedicmedicaldevices-boneplates;surgicaldevices;testmethods-surgicalimplants;
【摘要】:1.1Thisspecificationandtestmethodisintendedtoprovideacomprehensivereferenceforboneplatesusedinthesurgicalinternalfixationoftheskeletalsystem.Thestandardestablishesconsistentmethodstoclassify,definethegeometriccharacteristics,andperformancecharacteristicsofboneplates.Thestandardalsopresentsacatalogofstandardspecificationsthatspecifymaterial;labelingandhandlingrequirements;andstandardtestmethodsformeasuringperformancerelatedmechanicalcharacteristicsdeterminedtobeimportanttotheinvivoperformanceofboneplates.1.2Itisnottheintentionofthestandardtodefinelevelsofperformanceorcase-specificclinicalperformanceforboneplates,asinsufficientknowledgeisavailabletopredicttheconsequencesortheiruseinindividualpatientsforspecificactivitiesofdailyliving.Futhermore,itisnottheintentionofthestandardtodescribeorspecifyspecificdesignsforboneplatesusedinthesurgicalinternalfixationoftheskeletalsystem.1.3Thisstandardmaynotbeappropriateforalltypesofboneplates.Theuseriscautionedtoconsidertheappropriatenessofthestandardinviewofaparticularboneplateanditspotentialapplication.1.4Thisstandardincludesthefollowingtestmethodsusedindeterminingthefollowingboneplatemechanicalperformancecharacteristics.1.4.1StandardTestMethodforSingleCycleBendTestingofMetallicBonePlates-AnnexA1.1.4.2StandardTestMethodforDeterminingtheBendingFatiguePropertiesOfMetallicBonePlates-AnnexA2.1.5Unlessotherwiseindicated,thevaluesstatedinSIunitsshallberegardedasthestandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:12P.;A4
【正文语种】:
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