ASTM F1541-02(2015) Standard Specification and Test Methods for External Skeleta.

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1、Designation:F1541−02(Reapproved2015)StandardSpecificationandTestMethodsfor1ExternalSkeletalFixationDevicesThisstandardisissuedunderthefixeddesignationF1541;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevis

2、ion.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.3.7TestMethodforExternalSkeletalFixator/ConstructsSubassemblies—AnnexA7.1.1Thisspecificationprovidesacharacterizationofthedesi

3、gnandmechanicalfunctionofexternalskeletalfixation1.4ArationaleisgiveninAppendixX1.devices(ESFDs),testmethodsforcharacterizationofESFD1.5ThevaluesstatedinSIunitsaretoberegardedasmechanicalproperties,andidentifiesneedsforfurtherdevel-standard.Nootherunitsofmeasurementareinclu

4、dedinthisopmentoftestmethodsandperformancecriteria.Theultimatestandard.goalistodevelopaspecification,whichdefinesperformance1.6Thefollowingsafetyhazardscaveatpertainsonlytothecriteriaandmethodsformeasurementofperformance-relatedtestmethodportions(AnnexA2–AnnexA6):mechanical

5、characteristicsofESFDsandtheirfixationtobone.Itisnottheintentionofthisspecificationtodefinelevelsof1.7Thisstandarddoesnotpurporttoaddressalloftheperformanceorcase-specificclinicalperformanceofthesafetyconcerns,ifany,associatedwithitsuse.Itisthedevices,asinsufficientknowledgei

6、savailabletopredicttheresponsibilityoftheuserofthisstandardtoestablishappro-consequencesoftheuseofanyofthesedevicesinindividualpriatesafetyandhealthpracticesanddeterminetheapplica-patientsforspecificactivitiesofdailyliving.Furthermore,itisbilityofregulatorylimitationsprior

7、touse.nottheintentionofthisspecificationtodescribeorspecifyspecificdesignsforESFDs.2.ReferencedDocuments21.2ThisspecificationdescribesESFDsforsurgicalfixation2.1ASTMStandards:oftheskeletalsystem.ItprovidesbasicESFDgeometricalA938TestMethodforTorsionTestingofWiredefinitions,dim

8、ensions,classification,andterminology;mate-D790TestMethodsforFlexuralPropertiesofUnreinforcedrial