1、Designation: F2989 12Standard 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 r
2、evision, 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 grade
3、s 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
4、 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
5、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 Termi
6、nology 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 Te
7、sting 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 ofTitaniumAlloys by X-RayFluore
8、scence 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
9、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 SpectrometryE2626 Guide for Spectrometric Analysis of Reactive andRefractory MetalsF67 Specification for
10、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 Intern
11、a-tional System of Units (SI): The Modern Metric System2.2 ISO Standards:3ISO 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 M
12、aterial Specifications:4AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium Alloys2.4 MPIF Standards:5Standard 10 Determination of the Tensile Properties ofPowder Metallurgy Materials1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and De
13、vices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Dec. 1, 2012. Published January 2013. DOI: 10.1520/F2989-12.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For A
14、nnual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.4Available from SAE International (SAE), 400 Commonwealth Dr.
15、, Warrendale,PA 15096-0001, http:/aerospace.sae.org.5Available from Metal Powder Industries Federation (MPIF), 105 College Rd.East, Princeton, NJ 08540, http:/www.mpif.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1Standard 42 De
16、termination 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. Terminolog
17、y3.1 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 of the Annual Book of ASTM Standards.3.2 The materials produced by means of the metal injectionmolding
18、process are designated by the prefix, “MIM”, followedby the appropriate designation for the alloy grade. The MIMdesignates that it was made by metal injection molding.3.3 Definitions of Terms Specific to This Standard:3.3.1 absolute density, nthe value of density used tocharacterize a powder materia
19、l with a particular chemicalcomposition as if it were a fully dense material, completelyfree of porosity.3.3.1.1 DiscussionFor the purposes of this specification,the skeletal density (also referred to as pycnometer density)measured on the raw material powders using the pycnometrymethod of Test Metho
20、d B923 shall be used to represent theabsolute density of the particular chemical composition.3.3.2 debinding, va step between molding and sinteringwhere the majority of the binder used in molding is extractedby heat, solvent, a catalyst, or other techniques.3.3.3 feedstock, nin metal injection moldi
21、ng, a moldablemixture of metal powder and binder.3.3.4 feedstock batch, na specified quantity of feedstockmade up of the same lot of metallic powders and the same lotof binder materials mixed under the same conditions atessentially the same time.3.3.5 lot, na specified quantity of components made up
22、 ofthe same batch of feedstock, debound, sintered, and post-processed under the same conditions at essentially the sametime.3.3.6 metal injection molded component, nproduct fabri-cated by a metal injection molding process consisting ofmixing metal powders with binders to make a feedstock,introducing
23、 this feedstock into a mold by injection or othermeans, debinding to remove the binders, and sintering.3.3.7 near net component, na component that meetsdimensional tolerance as built with little post processing.3.3.8 net component, na component that meets dimen-sional tolerance as built with no post
24、 processing.3.3.9 pre-alloyed powder, npowder composed of two ormore elements that are alloyed in the powder manufacturingprocess in which the particles are of the same nominalcomposition throughout.3.3.10 relative density, nthe density ratio, often expressedas a percentage, of the density of a poro
25、us material to theabsolute density of the same material, completely free ofporosity.3.3.11 sintering, vthe metallurgical bonding of particles ina MIM component resulting from a thermal treatment at atemperature below the melting point of the main constituent.3.3.12 Type 1, na MIM component that may
26、have beendesified beyond its as-sintered density by post-sinter process-ing.3.3.13 Type 2, na MIM component that shows the as-sintered density and was not densified after sintering.4. Ordering Information4.1 Include with inquiries and orders for material under thisspecification the following informa
27、tion:4.1.1 Quantity,4.1.2 ASTM specification and date of issue,4.1.3 Grade (MIM 1, MIM 2 or MIM 3),4.1.4 Type (1 or 2),4.1.5 Units to be certifiedSI or Inch-Pounds,4.1.6 Component configuration (engineering drawing or 3Dsolid model, or both) and dimensional requirements,4.1.7 Condition (5.2),4.1.8 M
28、echanical properties (if applicable),4.1.9 Finish (5.2),4.1.10 Special tests (9, 10 and 11), if any, and4.1.11 Other requirements.5. Materials and Manufacture5.1 Components conforming to this specification shall beproduced by the metal injection molding process using unal-loyed metal powders with ma
29、jor elemental composition meet-ing the chemical requirements of Table 1.5.2 Post-sintering operations may be employed to achievethe desired density, shape, size, surface finish, or other com-ponent properties. The post-sintering operations shall beagreed upon between the supplier and purchaser.5.3 T
30、he condition and finish of the components shall beagreed upon between the supplier and purchaser.6. Chemical Requirements6.1 The components supplied under this specification shallconform to the chemical requirements in Table 1. The suppliershall not ship components with chemistry outside the require
31、-ments specified in Table 1.TABLE 1 Chemical CompositionComposition for both Type 1 and Type 2Composition, % (mass/mass)Element Grade MIM 1 Grade MIM 2 Grade MIM 3Nitrogen, max 0.03 0.03 0.05Carbon, max 0.08 0.08 0.08Hydrogen, max 0.015 0.015 0.015Iron, max 0.020 0.030 0.030Oxygen, max 0.18 0.25 0.3
32、0Titanium Balance Balance BalanceF2989 1226.2 Chemical analysis of the finished component or arepresentative sample shall be used for reporting all chemicalrequirements. Any representative sample shall be producedfrom the same feedstock batch, debound, sintered, and postprocessed concurrently with t
33、he finished components that itrepresents.6.2.1 Requirements for the major and minor elementalconstituents are listed in Table 1. Also listed are importantresidual elements. The percentage of titanium is determined bydifference and need not be determined or certified.6.2.2 Intentional elemental addit
34、ions other than those speci-fied in Table 1 are not permitted.6.2.3 Analysis for elements not listed in Table 1 is notrequired to verify compliance with this specification.6.3 Product Analysis:6.3.1 Product analysis tolerances do not broaden the speci-fied heat analysis requirements but cover variat
35、ions in themeasurement of chemical content between laboratories. Theproduct analysis tolerances shall conform to the producttolerances in Table 2.6.3.2 The product analysis is either for the purpose ofverifying the composition of the manufacturing lot or todetermine variations in the composition wit
36、hin the lot. Accep-tance or rejection of the manufacturing lot of components maybe made by the purchaser on the basis of this product analyses.6.3.3 Samples for chemical analysis shall be representativeof the component being tested. The utmost care shall be usedin sampling titanium for chemical anal
37、ysis because of itsaffinity for elements such as oxygen, nitrogen, and hydrogen.In cutting samples for analysis, therefore, the operation shouldbe carried out insofar as possible in a dust-free atmosphere.Cutting tools should be clean and sharp. Samples for analysisshould be stored in suitable conta
38、iners.6.3.4 Product analysis outside the tolerance limits allowedin Table 2 is cause for rejection of the product. A refereeanalysis may be used if agreed upon by the supplier andpurchaser.6.3.5 For referee purposes, use Test Methods E539, E1409,E1447, E1941, and E2371 and Guide E2626 or other analy
39、ticalmethods agreed upon between the purchaser and the supplier.7. Mechanical Requirements7.1 Tensile Properties:7.1.1 The components supplied under this specificationshall conform to the mechanical property requirements in Table3.7.1.2 Test specimens shall be taken from a MIM componentif possible,
40、or from a representative sample or molded tensilespecimen. A representative sample or molded tensile specimenmay only be used only if the component configuration is suchthat a tensile specimen cannot be obtained from the compo-nent.7.1.3 The number of tensile tests should be agreed uponbetween the s
41、upplier and the purchaser.7.2 Representative samples or molded tensile specimensshall be produced from the same feedstock batch, debound,sintered and post processed concurrently with the finishedcomponents that they represent.7.2.1 Specimens machined from components or representa-tive samples shall
42、be ground, or machined to final dimensionsin accordance Test Methods E8/E8M.7.2.2 Alternate tensile specimen geometries may be agreedupon between the purchaser and supplier. Some examples ofthe configurations for molded tensile specimens are describedin MPIF Standards 10 and 50.7.3 Specimens for ten
43、sile tests shall be tested in accordancewith Test Methods E8/E8M. Tensile properties shall be deter-mined using a strain rate of 0.076 to 0.178 mm/mm/min 0.003to 0.007 in./in./min through yield and then the crossheadspeed may be increased so as to produce fracture in approxi-mately one additional mi
44、nute.7.4 Should any test piece not meet the specifiedrequirements, test two additional representative test pieces, inthe same manner, for each failed test piece. The lot shall beconsidered in compliance only if all additional test pieces meetthe specified requirements.7.5 Tensile test results for wh
45、ich any specimen fracturesoutside the gauge length shall be considered valid if both theelongation and reduction of area meet the minimum require-ments specified. If either the elongation or reduction of area isless than the minimum requirement, invalidate the specimenand retest. Retest one specimen
46、 for each invalidated specimen.8. Dimensions and Permissible Variation8.1 Units of Measure:8.1.1 SelectionThis specification requires that the pur-chaser selects the units (SI or inch-pound) to be used forproduct certification. In the absence of a stated selection ofunits on the purchase order, this
47、 selection may be expressed bythe purchaser in several alternate forms listed in order ofprecedence.8.1.2 If the purchaser and supplier have a history of usingspecific units, these units shall continue to be certified untilexpressly changed by the purchaser.8.1.3 In the absence of historic precedenc
48、e, if the units usedto define the product on the purchasers purchase order,specification, and engineering drawing are consistent, theseunits shall be used by the supplier for product certification.TABLE 2 Product Analysis ToleranceAElementLimit or Maximum ofSpecified Range %,(mass/mass)Tolerance Und
49、er theMinimum or Over theMaximum LimitBNitrogen up to 0.05 0.02Carbon 0.10 0.02Hydrogen up to 0.015 0.002Iron up to 0.25 0.10Iron over 0.25 0.15Oxygen up to 0.20 0.02Oxygen over 0.20 0.03ASee AMS 2249.BUnder the minimum limit is not applicable for elements where only a maximumpercentage is indicated.F2989 1238.1.4 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between the purchaserand supplier.8.1.5 Conversion of UnitsIf the suppliers test equipmentdoes not report in the selected units, the test equipment unitsm
