Designation:F382−14StandardSpecificationandTestMethodforMetallicBonePlates1ThisstandardisissuedunderthefixeddesignationF382;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationandtestmethodisintendedtoprovideacomprehensivereferenceforboneplatesusedinthesurgicalinternalfixationoftheskeletalsystem.Thestandardestab-lishesconsistentmethodstoclassifyanddefinethegeometricandperformancecharacteristicsofboneplates.Thestandardalsopresentsacatalogofstandardspecificationsthatspecifymaterial;labelingandhandlingrequirements;andstandardtestmethodsformeasuringperformancerelatedmechanicalchar-acteristicsdeterminedtobeimportanttotheinvivoperfor-manceofboneplates.1.2Itisnottheintentionofthestandardtodefinelevelsofperformanceorcase-specificclinicalperformanceforboneplates,asinsufficientknowledgeisavailabletopredicttheconsequencesortheiruseinindividualpatientsforspecificactivitiesofdailyliving.Futhermore,itisnottheintentionofthestandardtodescribeorspecifyspecificdesignsforboneplatesusedinthesurgicalinternalfixationoftheskeletalsystem.1.3Thisdocumentmaynotbeappropriateforalltypesofboneplates.Theuseriscautionedtoconsidertheappropriate-nessofthestandardinviewofaparticularboneplateanditspotentialapplication.1.4Thisdocumentincludesthefollowingtestmethodsusedindeterminingthefollowingboneplatemechanicalperfor-mancecharacteristics:1.4.1StandardTestMethodforSingleCycleBendTestingofMetallicBonePlates—AnnexA1,and1.4.2StandardTestMethodforDeterminingtheBendingFatiguePropertiesOfMetallicBonePlates—AnnexA2.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Multipletestmethodsareincludedinthisstandard.However,itmustbenotedthattheuserisnotobligatedtotestusingallofthedescribedmethods.Instead,theusershouldonlyselec...
