【英文标准名称】:StandardSpecificationsandTestMethodsforMetallicAngledOrthopedicFractureFixationDevices
【原文标准名称】:金属斜角整形外科骨折固定设备的标准规范和试验方法
【标准号】:ASTMF384-2006
【标准状态】:现行
【国别】:
【发布日期】:2006
【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】:弯曲试验;医疗设备;医学科学;钉板;工艺;试验
【英文主题词】:angleddevices;bendtesting;bladeplate;compressionhipscrew;fatiguetest;orthopedicmedicaldevices;surgicaldevices;surgicalimplants
【摘要】:1.1Thesespecificationsandtestmethodsprovideacomprehensivereferenceforangleddevicesusedinthesurgicalinternalfixationoftheskeletalsystem.Thisstandardestablishesconsistentmethodstoclassifyanddefinethegeometricandperformancecharacteristicsofangleddevices.Thisstandardalsopresentsacatalogofstandardspecificationsthatspecifymaterial,labeling,andhandlingrequirements,andstandardtestmethodsformeasuringperformancerelatedmechanicalcharacteristicsdeterminedtobeimportanttotheinvivoperformanceofangleddevices.1.2Itisnottheintentionofthisstandardtodefinelevelsofperformanceofcase-specificclinicalperformanceforangleddevices,asinsufficientknowledgeisavailabletopredicttheconsequencesoftheiruseinindividualpatientsforspecificactivitiesofdailyliving.Futhermore,thisstandarddoesnotdescribeorspecifyspecificdesignsforangleddevicesusedinthesurgicalinternalfixationoftheskeletalsystem.1.3Thisstandardmaynotbeappropriateforalltypesofangleddevices.Theuseriscautionedtoconsidertheappropriatenessofthisstandardinviewofaparticularangleddeviceanditspotentialapplication.Note1Thisstandardisnotintendedtoaddressintramedullaryhipscrewnailsorotherangleddeviceswithoutasideplate.1.4Thisstandardincludesthefollowingtestmethodsusedindeterminingthefollowingangleddevicemechanicalperformancecharacteristics:1.4.1Standardtestmethodforsinglecyclecompressionbendtestingofmetallicangledorthopedicfracturefixationdevices(see).1.4.2Standardtestmethodfordeterminingthebendingfatiguepropertiesofmetallicangledorthopedicfracturefixationdevices(see).1.5Unlessotherwiseindicated,thevaluesstatedinSIunitsshallberegardedasthestandard.Note2ThereiscurrentlynoISOstandardthatiseithersimilartoequivalenttothisstandard.1.6Thistestmethoddescribesmethodsforbendingfatiguetestinginordertodetermineintrinsicstructuralpropertiesofmetallicangleddevices.Thetestmethodmaybeusedtodeterminethefatiguelifeataspecificoroverarangeofmaximumbendingmomentlevelsortoestimatethefatiguestrengthforaspecifiednumberoffatiguecyclesofanangleddevice.1.7Thistestmethodisintendedtoprovideameanstomechanicallycharacterizedifferentangleddevicedesigns.Thistestmethoddoesnotdefineangleddeviceperformancelevelssincethesecharacteristicsaredrivenbypatient-specificclinicalrequirements.1.8UnitsThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesandtodeterminetheapplicabilityofregulatorylimitationspriortouse.Note3Currently,thereisnoISOstandardthatissimilar,orequivalent,tothistestmethod.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:11P.;A4
【正文语种】: