ASTM F1541-2002(2007) 骨骼外部固定器设备的标准规范和试验方法

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【英文标准名称】:StandardSpecificationandTestMethodsforExternalSkeletalFixationDevices
【原文标准名称】:骨骼外部固定器设备的标准规范和试验方法
【标准号】:ASTMF1541-2002(2007)
【标准状态】:现行
【国别】:
【发布日期】:2002
【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】:硬挺度;术语;分类;实验室医学;生理学;试验方法;矫形外科学;主要产品
【英文主题词】:anchorageelement;bending;bridgeelement;connector;externalskeletalfixationdevice;fracturefixation;joints;modularity;orthopedicmedicaldevice;osteosynthesis;ringelement;subassembly(frame);terminology;torsion;bendingmoments;connectingelements;connectors;externalfixator;orthopedicdevice;stiffness;strength;bending;connectingelements;externalfixator;joints;orthopedicdevice;rangeofadjustability;rangeofmotion;stiffness;strength;torsion;externalfixation;four-pointbending;orthopedicdevice;pins;rigidity;stiffness;strength;torsion;bendtesting-orthopedicmedicaldevices;fatiguetesting-orthopedicmedicaldevices;orthopedicmedicaldevices-externalfixationdevices;testmethods-surgicaldevices
【摘要】:1.1Thisspecificationprovidesacharacterizationofthedesignandmechanicalfunctionofexternalskeletalfixationdevices(ESFDs),testmethodsforcharacterizationofESFDmechanicalproperties,andidentifiesneedsforfurtherdevelopmentoftestmethodsandperformancecriteria.Theultimategoalistodevelopaspecification,whichdefinesperformancecriteriaandmethodsformeasurementofperformance-relatedmechanicalcharacteristicsofESFDsandtheirfixationtobone.Itisnottheintentionofthisspecificationtodefinelevelsofperformanceorcase-specificclinicalperformanceofthedevices,asinsufficientknowledgeisavailabletopredicttheconsequencesoftheuseofanyofthesedevicesinindividualpatientsforspecificactivitiesofdailyliving.Furthermore,itisnottheintentionofthisspecificationtodescribeorspecifyspecificdesignsforESFDs.1.2ThisspecificationdescribesESFDsforsurgicalfixationoftheskeletalsystem.ItprovidesbasicESFDgeometricaldefinitions,dimensions,classification,andterminology;materialspecifications;performancedefinitions;testmethods;andcharacteristicsdeterminedtobeimportanttothein-vivoperformanceofthedevice.1.3Thisspecificationincludesaterminologyandclassificationannexandfivestandardtestmethodannexesasfollows:1.3.1ClassificationofExternalFixators.1.3.2TestMethodforExternalSkeletalFixatorConnectors.1.3.3TestMethodforDeterminingIn-PlaneCompressivePropertiesofCircularRingorRingSegmentBridgeElements.1.3.4TestMethodforExternalSkeletalFixatorJoints.1.3.5TestMethodforExternalSkeletalFixatorPinAnchorageElements.1.3.6TestMethodforExternalSkeletalFixatorSubassemblies.1.3.7TestMethodforExternalSkeletalFixator/ConstructsSubassemblies.1.4ArationaleisgiveninAppendixX1.1.5ThevaluesstatedinSIunitsaretoberegardedasthestandard.1.6Thefollowingsafetyhazardscaveatpertainsonlytothetestmethodportions(AnnexA2-AnnexA6):Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_120_20
【页数】:31P.;A4
【正文语种】: