ASTM_F_2063_-_12.pdf

Designation:F206312Standard Specification forWrought Nickel-Titanium Shape Memory Alloys for MedicalDevices and Surgical Implants1This standard is issued under the fixed designation F2063;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,physical,mechanical,and metallurgical requirements for wroughtnickel-titanium bar,flat rolled products,and tubes containingnominally 54.5-to 57.0-weight percent nickel and used for themanufacture of medical devices and surgical implants.1.2 Requirements are for mill product,measuring 5.50 to94.0 mm 0.218 to 3.70 in.diameter or thickness.Mill productis not intended to have the final shape,final surface finish,orfinal properties of the medical device,implant,or their com-ponents.Finished NiTi cold-worked tube should be consideredunder Specification F2633.1.3 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:2E4 Practices for Force Verification of Testing MachinesE8/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 SizeE1019 Test Methods for Determination of Carbon,Sulfur,Nitrogen,and Oxygen in Steel,Iron,Nickel,and CobaltAlloys by Various Combustion and Fusion TechniquesE1097 Guide for Determination of Various Elements byDirect Current Plasma Atomic Emission SpectrometryE1172 Practice for Describing and Specifying a Wavelength-Dispersive X-Ray SpectrometerE1245 Practice for Determining the Inclusion or Second-Phase Constituent Content of Metals by Automatic ImageAnalysisE1409 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 MethodE1479 Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission SpectrometersE1941 Test Method for Determination of Carbon in Refrac-tory and Reactive Metals and TheirAlloys by CombustionAnalysisF1710 Test Method for Trace Metallic Impurities in Elec-tronic Grade Titanium by High Mass-Resolution GlowDischarge Mass SpectrometerF2004 Test Method for Transformation Temperature ofNickel-Titanium Alloys by Thermal AnalysisF2005 Terminology for Nickel-Titanium Shape MemoryAlloysF2633 Specification for Wrought Seamless Nickel-TitaniumShape Memory Alloy Tube for Medical Devices andSurgical ImplantsIEEE/ASTM SI 10 American National Standard for MetricPractice2.2 Other Standards:ASQ C1 General Requirements for a Quality Program3ISO 9001 Quality Management SystemsRequirements43.Terminology3.1 The terminology describing the physical and thermalproperties of these alloys shall be as defined in TerminologyF2005.3.2 See also Practice E4:General Terminology.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 Dec.1,2012.Published January 2013.Originallyapproved in 2000.Last previous edition approved in 2005 as F2063 05.DOI:10.1520/D206312.2For 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.3Available from American Society for Quality(ASQ),600 N.Plankinton Ave.,Milwaukee,WI 53203.Available from American Society for Quality(ASQ),600 N.Plankinton Ave.,Milwaukee,WI 53203,http:/www.asq.org.4Available 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 3.3 Definitions:3.3.1 mill product,nany finished or semi-finished productfrom a mill.Product may be straight or coiled.Product typesinclude hot-worked,hot-worked and cold-finished,and hot-worked and cold-worked,with or without a final heat treat-ment.NOTE1Mill product is not intended to have the final shape,finalsurface finish,or final properties of the medical device,implant,or theircomponents.4.Product Classification4.1 BarRound bars and flats from 5.50 to 94.0 mm 0.218to 3.70 in.in diameter