ASTM_F_2989_-_13.pdf

Designation:F298913Standard Specification forMetal Injection Molded Unalloyed Titanium Components forSurgical Implant Applications1This standard is issued under the fixed designation F2989;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 three grades of metal injectionmolded(MIM)unalloyed titanium components in two types tobe used in the manufacture of surgical implants.1.2 The Type 1 MIM components covered by this specifi-cation may have been densified beyond their as-sintereddensity by post-sinter processing.1.3 Values in either inch-pound or SI are to be regardedseparately as standard.The values stated in each system maynot be exact equivalents;therefore each system shall be usedindependent of the other.Combining values from the twosystems may result in non-conformance with the specification.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2B243 Terminology of Powder MetallurgyB311 Test Method for Density of Powder Metallurgy(PM)Materials Containing Less Than Two Percent PorosityB923 Test Method for Metal Powder Skeletal Density byHelium or Nitrogen PycnometryE3 Guide for Preparation of Metallographic SpecimensE8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE165 Practice for Liquid Penetrant Examination for GeneralIndustryE407 Practice for Microetching Metals and AlloysE539 Test Method forAnalysis of TitaniumAlloys by X-RayFluorescence SpectrometryE1409 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)3E2626 Guide for Spectrometric Analysis of Reactive andRefractory MetalsF67 Specification for Unalloyed Titanium,for Surgical Im-plant Applications(UNS R50250,UNS R50400,UNSR50550,UNS R50700)F601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF629 Practice for Radiography of Cast Metallic SurgicalImplantsSI 10 American National Standard for Use of the Interna-tional System of Units(SI):The Modern Metric System2.2 ISO Standards:4ISO 5832-3 Implants for SurgeryMetallic MaterialsPart3:Wrought Titanium 6-Aluminum 4-Vanadium AlloyISO 6892 Metallic MaterialsTensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements2.3 Aerospace Material Specifications:5AMS 2249 Chemical Check Analysis Limits,Titanium andTitanium Alloys1This 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 1,2013.Published April 2013.Originallyapproved in 2012.Last previous edition approved in 2012 as F2989 12.DOI:10.1520/F2989-13.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.5Available from SAE International(SAE),400 Commonwealth Dr.,Warrendale,PA 15096-0001,http:/aerospace.sae.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 2.4 MPIF Standards:6Standard 10 Determination of the Tensile Properties ofPowder Metallurgy MaterialsStandard 42 Determination of Density of Compacted orSintered Powder Metallurgy ProductStandard 50 Preparing and Evaluating Metal InjectionMolded Sintered/Heat Treated Tension SpecimensStandard 63 Density Determinations of MIM Components(Gas Pycnometry)Standard 64 Terms Used in Metal Injection Molding3.Terminology3.1 Definitions of powder metallurgy and MIM terms can befound in Terminology B243 and MPIF Standard 64.Additionaldescriptive information is available in the Related MaterialSection of Vol.02.05