Designation:F560−13´1StandardSpecificationforUnalloyedTantalumforSurgicalImplantApplications(UNSR05200,UNSR05400)1ThisstandardisissuedunderthefixeddesignationF560;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.ε1NOTE—ThedesignationwascorrectededitoriallyinDecember2013.1.Scope*1.1Thisspecificationcoversthechemical,mechanical,andmetallurgicalrequirementsforunalloyedtantalumplate,sheet,strip,bar,andwireusedinthemanufactureofsurgicalimplants.1.2ThevaluesstatedineitherSIunitsorinch-poundunitsaretoberegardedseparatelyasstandard.Thevaluesstatedineachsystemmaynotbeexactequivalents;therefore,eachsystemshallbeusedindependentlyoftheother.Combiningvaluesofthetwosystemsmayresultinnon-conformancewiththisstandard.2.ReferencedDocuments2.1ASTMStandards:2E8/E8MTestMethodsforTensionTestingofMetallicMa-terialsE29PracticeforUsingSignificantDigitsinTestDatatoDetermineConformancewithSpecificationsF981PracticeforAssessmentofCompatibilityofBiomate-rialsforSurgicalImplantswithRespecttoEffectofMaterialsonMuscleandBoneIEEE/ASTMSI10AmericanNationalStandardforUseoftheInternationalSystemofUnits(SI):TheModernMetricSystem2.2ISOStandards:3ISO6892MetallicMaterialsTensileTestingatAmbientTemperatureISO9001QualityManagementSystems—RequirementsISO13782ImplantsforSurgery—MetallicMaterials—UnalloyedTantalumforSurgicalImplantApplications3.Terminology3.1DefinitionsofTermsSpecifictoThisStandard:3.1.1lot—allmaterialproducedfromthesameingotorasinglepowderblendwiththesamecrosssectionunderthesameconditionsatessentiallythesametime.3.1.2plate—aflatproductmorethan4.75mm[0.1875in.]inthickness.3.1.3bar—material3.15to63.5mm[0.125to2.5in.]indiameterinround,hexagonal,oroctagonalcrosssectionsuppliedinstraightlengths.3.1.4sheet—aflatproduct150mm[6in.]ormoreinwidthandfrom0.13to4.75mm[0.005to0.1875in.]int...
