ASTM_F_2384_-_10_2016.pdf

Designation:F238410(Reapproved 2016)Standard Specification forWrought Zirconium-2.5Niobium Alloy for Surgical ImplantApplications(UNS R60901)1This standard is issued under the fixed designation F2384;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.Scope1.1 This specification covers the chemical,mechanical,andmetallurgical requirements for wrought zirconium-2.5niobiumalloy to be used in the manufacture of surgical implants(1).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:3B550/B550M Specification for Zirconium and ZirconiumAlloy Bar and WireE8/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 SizeE1552 Test Method for Determining Hafnium in Zirconiumand ZirconiumAlloys By Direct Current PlasmaAtomicEmission SpectrometryE1941 Test Method for Determination of Carbon in Refrac-tory and Reactive Metals and TheirAlloys by CombustionAnalysisE2626 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 DevicesSI 10 American National Standard for Use of the Interna-tional System of Units(SI):The Modern Metric System2.2 ISO Standard:4ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 annealed,adjmaterial that exhibits a recrystalizedgrain structure.3.1.2 lot,nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.4.Product Classification4.1 barrounds,flats or shapes from 4.76 to 101.60 mm0.1875 to 4 in.in diameter or thickness(other sizes andshapes by special order).4.2 wirerounds or flats less than 4.76 mm 0.1875 in.indiameter 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 Units to be certifiedSI or inch-pound,5.1.4 Grade(if applicable),5.1.5 Form(bar,or wire),5.1.6 Condition(see 6.3),5.1.7 Mechanical properties(if applicable for specialconditions),5.1.8 Finish(see 6.2),5.1.9 Applicable dimension including size,thickness,width,or drawing number,5.1.10 Special tests,if any,and1This 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 April 1,2016.Published June 2016.Originallyapproved in 2005.Last previous edition approved in 2010 as F2384 10.DOI:10.1520/F2384-10R16.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.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.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.1.11 Other requirements.6.Materials and Manufacture6.1 Materials covered by this specification shall be pro-duced by multiple vacuum melting in arc furnaces,electronbeam melting,or other melting processes conventionally usedfor reactive metals.6.2 FinishThe mill product may be furnished to theimplant manufacturer as descaled or pickled,abrasivelyblasted,chemically milled,ground,machined,peeled,polished,or as specified by the purchaser.6.3 ConditionBarstock shall be furnished in the annealedcondition unless otherwise specified.7.Chemical Requirements7.1 The heat analysis shall conform to the chemical com-position of Table 1.Ingot analysis may be used for reporting allchemical requirements,except hydrogen,oxygen,and nitro-gen.Samples for hydrogen,oxygen and nitrogen shall be takenfrom the finished mill product.The supplier shall not shipmaterial with chemistry outside the requirements specified inTable 1.Guide E2626 may be used as a guide for chemicalanalysis techniques.7.1.1 Requirements for the major and minor elementalconstitu