1、Designation: F2989 13Standard 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 Spectrometry (With-drawn 2013)3E2626 Guide for Spectrometric Analysis of Reactive andRefractory MetalsF67
10、 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 fo
11、r 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 SystemsRequirem
12、ents2.3 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 Mate
13、rials.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 Annua
14、l 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,
15、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 States12.4 MPIF Standards:6Standard 10 Determination of the T
16、ensile 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)S
17、tandard 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 of the Annual Book of ASTM Standards.3.2 T
18、he materials produced by means of the metal injectionmolding 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 densit
19、y, nthe value of density used tocharacterize a powder material 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
20、raw material powders using the pycnometrymethod of Test Method 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, o
21、r other techniques.3.3.3 feedstock, nin metal injection molding, 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 sam
22、e time.3.3.5 lot, na specified quantity of components made up 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 ofmixi
23、ng metal powders with binders to make a feedstock,introducing 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 comp
24、onent that meets dimen-sional tolerance as built with no post 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 ra
25、tio, often expressedas a percentage, of the density of a porous 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 t
26、he main constituent.3.3.12 Type 1, na MIM component that may 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 orde
27、rs for material under thisspecification the following information: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 bot
28、h) and dimensional requirements,4.1.7 Condition (5.2),4.1.8 Mechanical 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 inj
29、ection molding process using unal-loyed metal powders with major 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
30、 shall beagreed upon between the supplier and purchaser.5.3 The condition and finish of the components shall beagreed upon between the supplier and purchaser.6Available from Metal Powder Industries Federation (MPIF), 105 College Rd.East, Princeton, NJ 08540, http:/www.mpif.org.TABLE 1 Chemical Compo
31、sitionComposition 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 0.20 0.30 0.30Oxygen, max 0.18 0.25 0.30Titanium Balance Balance BalanceF2989 1326. Chemical
32、 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-ments specified in Table 1.6.2 Chemical analysis of the finished component or arepresentative sample shall
33、be used for reporting all chemicalrequirements. Any representative sample shall be producedfrom the same feedstock batch, debound, sintered, and postprocessed concurrently with the finished components that itrepresents.6.2.1 Requirements for the major and minor elementalconstituents are listed in Ta
34、ble 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 additions other than those speci-fied in Table 1 are not permitted.6.2.3 Analysis for elements not listed in Table 1 is notrequ
35、ired 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 variations in themeasurement of chemical content between laboratories. Theproduct analysis tolerances shall conform to the produ
36、cttolerances 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 within the lot. Accep-tance or rejection of the manufacturing lot of components maybe made by the purchaser on the basis of t
37、his 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 analysis because of itsaffinity for elements such as oxygen, nitrogen, and hydrogen.In cutting samples for analysis, therefore
38、, 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 containers.6.3.4 Product analysis outside the tolerance limits allowedin Table 2 is cause for rejection of the product. A refer
39、eeanalysis 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 analyticalmethods agreed upon between the purchaser and the supplier.7. Mechanical Requirements7.1 Tensile Properties:7.1.1 The
40、 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, or from a representative sample or molded tensilespecimen. A representative sample or molded tensile specimenmay only be u
41、sed 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 supplier and the purchaser.7.2 Representative samples or molded tensile specimensshall be produced from the same feedstock
42、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 be ground, or machined to final dimensionsin accordance Test Methods E8/E8M.7.2.2 Alternate tensile specimen geometries ma
43、y 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 tensile tests shall be tested in accordancewith Test Methods E8/E8M. Tensile properties shall be deter-mined using a strain r
44、ate 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 minute.7.4 Should any test piece not meet the specifiedrequirements, test two additional representative test pieces, inthe s
45、ame 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 which any specimen fracturesoutside the gauge length shall be considered valid if both theelongation and reduction of area m
46、eet 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 for each invalidated specimen.8. Dimensions and Permissible Variation8.1 Units of Measure:8.1.1 SelectionThis specificati
47、on 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 selection may be expressed bythe purchaser in several alternate forms listed in order ofprecedence.8.1.2 If the purchaser
48、 and supplier have a history of usingspecific units, these units shall continue to be certified untilexpressly changed by the purchaser.TABLE 2 Product Analysis ToleranceAElementLimit or Maximum ofSpecified Range %,(mass/mass)Tolerance Under theMinimum or Over theMaximum LimitBNitrogen up to 0.05 0.
49、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 1338.1.3 In the absence of historic precedence, 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.8.1.4 If the purchasers selection of units is unclear, theunits of measur
