【英文标准名称】:StandardSpecificationandTestMethodforMetallicBonePlates
【原文标准名称】:金属骨板的检测及标准规范
【标准号】:ASTMF382-1999(2008)e1
【标准状态】:现行
【国别】:美国
【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(US-ASTM)
【起草单位】:F04.21
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:bendtesting&x2014;surgicalimplants;fatiguetest;boneplate;orthopedicmedicaldevices&x2014;boneplates;surgicaldevices;testmethods&x2014;surgicalimplants;Be
【摘要】:A2.5.1Thetestmethodestablishesauniformfour-pointbendingfatiguetesttocharacterizeandcomparethefatigueperformanceofdifferentboneplatedesigns.Thistestmethodmaybeusedtodetermineaboneplate''sfatiguelifeateitheraspecificoroverarangeofmaximumbendingmomentconditions.Additionally,thetestmethodmaybealternativelyusedtoestimateaboneplate''sfatiguestrengthforaspecifiednumberoffatiguecycles.A2.5.2Thetestmethodutilizesasimplifiedboneplateloadmodelthatmaynotbeexactlyrepresentativeofthein-situloadingconfiguration.Theusershouldnotethatthetestresultsgeneratedbythistestmethodcannotbeusedtodirectlypredicttheinvivoperformanceoftheboneplatebeingtested.Thedatageneratedfromthistestmethodcanbeusedtoconductrelativecomparisonsofdifferentboneplatedesigns.A2.5.3Thistestmethodmaynotbeappropriateforalltypesofimplantapplications.Theuseriscautionedtoconsidertheappropriatenessofthemethodinviewofthedevicesbeingtestedandtheirpotentialapplication.A2.5.4Thistestmethodassumesthattheboneplateismanufacturedfromamaterialthatexhibitslinear-elasticmaterialbehavior.Therefore,themethodisnotapplicablefortestingboneplatesmadefrommaterialsthatexhibitnon-linearelasticbehavior.A2.5.5Thistestmethodisrestrictedtothetestingofboneplateswithinthematerials''linear-elasticrange.Therefore,thetestmethodisnotapplicablefortestingboneplatesunderconditionsthatwouldapproachorexceedthebendingstrengthoftheboneplatebeingtested.1.1Thisspecificationandtestmethodisintendedtoprovideacomprehensivereferenceforboneplatesusedinthesurgicalinternalfixationoftheskeletalsystem.Thestandardestablishesconsistentmethodstoclassify,definethegeometriccharacteristics,andperformancecharacteristicsofboneplates.Thestandardalsopresentsacatalogofstandardspecificationsthatspecifymaterial;labelingandhandlingrequirements;andstandardtestmethodsformeasuringperformancerelatedmechanicalcharacteristicsdeterminedtobeimportanttotheinvivoperformanceofboneplates.1.2Itisnottheintentionofthestandardtodefinelevelsofperformanceorcase-specificclinicalperformanceforboneplates,asinsufficientknowledgeisavailabletopredicttheconsequencesortheiruseinindividualpatientsforspecificactivitiesofdailyliving.Futhermore,itisnottheintentionofthestandardtodescribeorspecifyspecificdesignsforboneplatesusedinthesurgicalinternalfixationoftheskeletalsystem.1.3Thisdocumentmaynotbeappropriateforalltypesofboneplates.Theuseriscautionedtoconsidertheappropriatenessofthestandardinviewofaparticularboneplateanditspotentialapplication.1.4Thisdocumentincludesthefollowingtestmethodsusedindeterminingthefollowingboneplatemechanicalperformancecharacteristics.1.4.1StandardTestMethodforSingleCycleBendTestingofMetallicBonePlatesx2014;AnnexA1.1.4.2StandardTestMethodforDeterminingtheBendingFatiguePropertiesOfMetallicBonePlatesx2014;AnnexA2.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpractices......
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:12P.;A4
【正文语种】:英语