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【英文标准名称】:TestMethodforConstantAmplitudeofForceControlledFatigueTestingofAcrylicBoneCementMaterials
【原文标准名称】:聚丙烯骨用水泥材料力控疲劳试验的恒定幅值的试验方法
【标准号】:ASTMF2118-2003
【标准状态】:现行
【国别】:
【发布日期】:2003
【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】:F04.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:水泥;疲劳试验;医疗技术学;试验方法;外科学;聚丙烯晴材料
【英文主题词】:acrylicbonecement;fatigue;fatiguestrength
【摘要】:Thistestmethoddescribesauniaxial,constantamplitude,fullyreversedfatiguetesttocharacterizethefatigueperformanceofauniformcylindricalwaistedspecimenmanufacturedfromacrylicbonecement.Thistestmethodconsiderstwoapproachestoevaluatingthefatigueperformanceofbonecement:5.2.1Testingisconductedatthreestresslevelstocharacterizethegeneralfatiguebehaviorofacementoverarangeofstresses.ThestresslevelandresultantcyclestofailureofthespecimensareplottedonanS-Ndiagram.5.2.2Anotherapproachistodeterminethefatiguestrengthofaparticularcement.Thefatiguestrengthfororthopaedicbonecementistobedeterminedat5million(5x00D7;106)cycles.Thex201C;two-pointmethodx201D;isthespecifiedprocedureforconductingfatiguetestingtodeterminefatiguestrength[1].Thistestmethoddoesnotdefineorsuggestrequiredlevelsofperformanceofbonecement.Thisfatiguetestmethodisnotintendedtorepresenttheclinicaluseoforthopaedicbonecement,butrathertocharacterizethematerialusingstandardandwell-establishedmethods.Theuseriscautionedtoconsidertheappropriatenessofthistestmethodinviewofthematerialbeingtestedanditspotentialapplication.Itiswidelyreportedthatmultipleclinicalfactorsaffectthefatigueperformanceoforthopaedicbonecement;however,theactualmechanismsinvolvedarenotwellunderstood.Clinicalfactorswhichmayaffecttheperformanceofbonecementinclude:temperatureandhumidity,mixingmethod,timeofapplication,surgicaltechnique,bonepreparation,implantdesign,andpatientfactors,amongothers.Thistestmethoddoesnotspecificallyaddresstheseclinicalfactors.Thetestmethodcanbeusedtocomparedifferentacrylicbonecementformulationsandproductsanddifferentmixingmethodsandenvironments(thatis,mixingtemperature,vacuum,centrifugation,andsoforth).1.1Thisstandarddescribestestproceduresforevaluatingtheconstantamplitude,uniaxial,tension-compressionuniformfatigueperformanceofacrylicbonecementmaterials.1.2Thisstandardisrelevanttoorthopaedicbonecementsbasedonacrylicresins,asspecifiedinSpecificationF451.Theproceduresinthisguidemayormaynotapplytoothersurgicalcementmaterials.1.3Itisnottheintentionofthisstandardtodefinelevelsofperformanceofthesematerials.Furthermore,itisnottheintentionofthisstandardtodirectlysimulatetheclinicaluseofthesematerials.1.4ArationaleisgiveninAppendixX1.1.5ThevaluesstatedinSIunitsaretoberegardedasthestandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcernsassociatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoconsultandestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:Q11
【国际标准分类号】:91_100_10
【页数】:8P.;A4
【正文语种】: