ASTM_F_1813_-_13.pdf

Designation:F181313Standard Specification forWrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy forSurgical Implant(UNS R58120)1This standard is issued under the fixed designation F1813;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope*1.1 This specification covers the chemical,mechanical,andmetallurgicalrequirementsforwroughttitanium-12molybdenum-6zirconium-2iron alloy mill products to beused in the manufacture of surgical implants.21.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard.The values stated ineach system may not be exact equivalents;therefore,eachsystem shall be used independently of the other.Combiningvalues from the two systems may result in non-conformancewith the standard.2.Referenced Documents2.1 ASTM Standards:3E8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeE1409 Test Method for Determination of Oxygen and Nitro-gen in Titanium and Titanium Alloys by the Inert GasFusion TechniqueE1447 Test Method for Determination of Hydrogen in Tita-nium and Titanium Alloys by Inert Gas Fusion ThermalConductivity/Infrared Detection MethodE1941 Test Method for Determination of Carbon in Refrac-tory and Reactive Metals and TheirAlloys by CombustionAnalysisE2371 Test Method for Analysis of Titanium and TitaniumAlloys by Atomic Emission Plasma Spectrometry(With-drawn 2013)4E2626 Guide for Spectrometric Analysis of Reactive andRefractory MetalsF67 Specification for Unalloyed Titanium,for Surgical Im-plant Applications(UNS R50250,UNS R50400,UNSR50550,UNS R50700)F748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesIEEE/ASTM SI 10 American National Standard for MetricPractice2.2 Aerospace Materials Specification:5AMS 2249 Chemical Check Analysis Limits,Titanium andTitanium AlloysAMS 2631 Ultrasonic InspectionTitanium and TitaniumAlloy Bar,Billet and PlateAMS 2380Approval and Control of Premium-QualityTitanium Alloys2.3 ISO Standards:6ISO 6982 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management Standard3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 beta transus,nthe minimum temperature at whichthe alpha plus beta phase can transform to 100%beta phase.3.1.2 hot work,nany mechanical deformation processperformed above the recrystallization temperature.3.1.3 lot,nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved March 1,2013.Published April 2013.Originallyapproved in 1997.Last previous edition approved in 2006 as F1813 06.DOI:10.1520/F1813-13.2FDA 510K application number K903630.3For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.4The last approved version of this historical standard is referenced onwww.astm.org.5Available from Society of Automotive Engineers(SAE),400 CommonwealthDr.,Warrendale,PA 15096-0001,http:/www.sae.org.6Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.4 solution anneal,vto heat treat in order to removeprecipitates.4.Product Classification4.1 BarRounds,flats or other shapes from 0.188 in.4.76mm to 4.0 in.102 mm in diameter or thickness.(Other sizesand shapes by special order.)4.2 Forging BarBar as described in 4.1 used in theproduction of forgings.This product may be furnished in thehot worked condition.4.3 WireRounds,flats,or other shapes less than 0.188 in.4.76 mm in diameter or thickness.5.Ordering Information5.1 Include with inquiries and orders for material under thisspecification the following information:5.1.1 Quantity,5.1.2 ASTM designation and date of issue,5.1.3 Form(strip,sheet,plate,bar,forging bar or wire),5.1.4 Condition(see 6.2),5.1.5 Mechanical properties(if applicable for specialconditions),5.1.6 Finish(see 6.1),5.1.7 Applicable dimensions including size,thickness,width,length or drawing number,5.1.8 Special tests,(if any),and5.1.9 Other requirements.6.Materials and Manufacture6.1 FinishThe mill product may be supplied as spe