1、Designation: F2885 11Standard Specification forMetal Injection Molded Titanium-6Aluminum-4VanadiumComponents for Surgical Implant Applications1This standard is issued under the fixed designation F2885; the number immediately following the designation indicates the year oforiginal adoption or, in the
2、 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 t
3、wo types of metal injectionmolded (MIM) titanium-6aluminum-4vanadium componentsto be 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-p
4、ound 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 purpor
5、t 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
6、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 Tensi
7、on Testing of MetallicMaterialsE29 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 for X-Ray Fluorescence SpectrometricAnal
8、ysis of 6Al-4V Titanium AlloyE1409 Test Method for Determination of Oxygen andNitrogen in Titanium and Titanium Alloys by the Inert GasFusion TechniqueE1447 Test Method for Determination of Hydrogen inTitanium and Titanium Alloys by Inert Gas Fusion Ther-mal Conductivity/Infrared Detection MethodE19
9、41 Test Method for Determination of Carbon in Refrac-tory and Reactive Metals and Their Alloys by CombustionAnalysisE2371 Test Method for Analysis of Titanium and TitaniumAlloys by Atomic Emission Plasma SpectrometryE2626 Guide for Spectrometric Analysis of Reactive andRefractory MetalsF601 Practice
10、 for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF629 Practice for Radiography of Cast Metallic SurgicalImplantsF1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants (UNS R56406)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy f
11、or Surgical Implant Applications (UNSR56400)SI 10 American National Standard for Use of the Interna-tional System of Units (SI): The Modern Metric System2.2 ISO Standards:3ISO 5832-3 Implants for SurgeryMetallic MaterialsPart 3: Wrought Titanium 6-Aluminum 4-Vanadium AlloyThird EditionISO 6892 Metal
12、lic MaterialsTensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements2.3 Aerospace Material Specifications:4AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium Alloys2.4 MPIF Standards:51This specification is under the jurisdiction of ASTM Committee F04 onMedica
13、l and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved March 1, 2011. Published March 2011. DOI: 10.1520/F288511.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Serv
14、ice at serviceastm.org. For Annual 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 American Society
15、 for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.5Available from Metal Powder Industries Federation (MPIF), 105 College Rd.East, Princeton, NJ 08540, http:/www.mpif.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-295
16、9, United States.Standard 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 Densit
17、y 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 Vo
18、l. 02.05 of the Annual Book of ASTM Standards.3.2 Definitions of Terms Specific to This Standard:3.2.1 metal injection molded component, nproduct fabri-cated by a metal injection molding process consisting ofmixing metal powders with binders to make a feedstock,introducing this feedstock into a mold
19、 by injection or othermeans, debinding to remove the binders, and sintering.3.2.2 feedstock, nin metal injection molding, a moldablemixture of metal powder and binder.3.2.3 feedstock batch, na specified quantity of feedstockmade up of the same lot of metallic powders and the same lotof binder materi
20、als mixed under the same conditions atessentially the same time.3.2.4 lot, na specified quantity of components made up ofthe same batch of feedstock, debound, sintered and postprocessed under the same conditions at essentially the sametime.3.2.5 debinding, va step between molding and sinteringwhere
21、the majority of the binder used in molding is extractedby heat, solvent, a catalyst or other techniques.3.2.6 sintering, vthe metallurgical bonding of particles ina MIM component resulting from a thermal treatment at atemperature below the melting point of the main constituent.3.2.7 pre-alloyed powd
22、er, npowder composed of two ormore elements that are alloyed in the powder manufacturingprocess in which the particles are of the same nominalcomposition throughout.3.2.8 absolute density, nthe value of density used tocharacterize a powder material with a particular chemicalcomposition as if it were
23、 a fully dense material, completelyfree of porosity.3.2.8.1 DiscussionFor purposes of this specification, theskeletal density (also referred to as pycnometer density)measured on the raw material powders using the pycnometrymethod of Test Method B923 will be used to represent theabsolute density of t
24、he particular chemical composition.3.2.9 relative density, nthe density ratio, often expressedas a percentage, of the density of a porous material to theabsolute density of the same material, completely free ofporosity.4. Ordering Information4.1 Include with inquiries and orders for material under t
25、hisspecification the following information:4.1.1 Quantity,4.1.2 ASTM specification and date of issue,4.1.3 Type 1 or Type 2,4.1.4 Units to be certifiedSI or Inch-Pounds,4.1.5 Component configuration (engineering drawingand/or 3D solid model) and dimensional requirements,4.1.6 Condition (5.2),4.1.7 M
26、echanical properties (if applicable),4.1.8 Finish (5.2),4.1.9 Special tests (Sections 9, 10, and 11), if any, and4.1.10 Other requirements.5. Materials and Manufacture5.1 Components conforming to this specification shall beproduced by the metal injection molding process using preal-loyed metal powde
27、rs 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 compo-nent properties. The post sintering operations shall be agreedupon between the supplier and purcha
28、ser.5.3 Condition and finish of the components shall be agreedupon between the supplier and purchaser.6. Chemical Requirements6.1 The components supplied under this specification shallconform to the chemical requirements in Table 1. Supplier shallnot ship components with chemistry outside the requir
29、ementsspecified in Table 1.6.2 Chemical analysis of the finished component or repre-sentative sample shall be used for reporting all chemicalrequirements. Any representative sample shall be producedfrom the same feedstock batch, debound, sintered, and postprocessed concurrently with the finished com
30、ponents 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 determinedby difference and need not be determined or certified.6.2.2 Intentional elemental additions other than
31、 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:TABLE 1 Chemical CompositionComposition for both Type 1 and Type 2 AlloysElementComposition, % (Mass/Mass)min maxNitrogen
32、. 0.05Carbon . 0.08Hydrogen . 0.015Iron . 0.30Oxygen . 0.20Aluminum 5.5 6.75Vanadium 3.5 4.5Yttrium . 0.005TitaniumABalanceAThe percentage of titanium is determined by difference and need not bedetermined or certified.F2885 1126.3.1 Product analysis tolerances do not broaden the speci-fied heat anal
33、ysis requirements but cover variations 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
34、 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 this product analyses.6.3.3 Samples for chemical analysis shall be representativeof the component being tested. The utmost care must be usedin sa
35、mpling titanium for chemical analysis 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 analysiss
36、hould 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 refereeanalysis may be used if agreed upon by supplier and purchaser.6.3.5 For referee purposes, use Test Methods E539, E1409,E1447, E1941, E2371 and
37、Guide E2626 or other analyticalmethods 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
38、MIM componentif possible, or from a representative sample or molded tensilespecimen. A representative sample or molded tensile specimenmay only be used if the component configuration is such thata tensile specimen cannot be obtained from the component.7.2 Representative samples or molded tensile spe
39、cimensshall 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 be ground, or machined to final dimensionsin accordance with Test Methods
40、E8/E8M.7.2.2 Alternate tensile specimen geometries may be agreedupon between purchaser and supplier. Some examples of theconfigurations for molded tensile specimens are described inMPIF Standard 10 and Standard 50.7.3 Specimens for tensile tests shall be tested in accordancewith Test Methods E8/E8M.
41、 Tensile properties shall be deter-mined using a strain rate of 0.003 to 0.007 mm/mm/min(in./in./min) through yield and then the crosshead speed may beincreased so as to produce fracture in approximately oneadditional minute.7.4 Should any test piece not meet the specified require-ments, test two ad
42、ditional representative test pieces, in thesame manner, for each failed test piece. The lot shall beconsidered in compliance only if all additional test pieces meetthe specified requirements.7.5 Tensile tests results for which any specimen fracturesoutside the gauge length shall be considered valid
43、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 for each invalidated specimen.8. Dimensions and Permissible Variation8.1 Uni
44、ts 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 selection may be expressed bythe purchaser in several alternate forms listed
45、 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 precedence, if the units usedto define the product on the purchasers purchase order ,s
46、pecification, 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 measure shall be agreed upon between purchaser andsupplier.8.1.5 Conversion of UnitsIf the suppliers test equipm
47、entdoes not report in the selected units, the test equipment unitsmay be converted to the selected units for certification pur-poses. Accurate arithmetic conversion and proper use ofsignificant digits should be observed when performing thisconversion. ASTM SI 10 provides guidelines for the use of SI
48、TABLE 2 Product Analysis ToleranceAElementTolerance Under the Minimum orOver the Maximum LimitComposition (% mass/mass)BNitrogen 0.02Carbon 0.02Hydrogen 0.002Iron, max 0.10Oxygen 0.02Aluminum 0.40Vanadium 0.15Yttrium 0.0006ASee AMS 2249.BUnder minimum limit not applicable for elements where only a m
49、aximumpercentage is indicated.TABLE 3 Mechanical RequirementsType 1DensifiedType 2SinteredUltimate Tensile Strength 900 MPa min(130 000 psi)780 MPa min(113 000 psi)Yield Strength (0.2 % offset) 830 MPa min(120 000 psi)680 MPa min(99 000 psi)ElongationA10%min 10%minReduction of Area 15 % min 15 % minAElongation of material 1.575 mm (0.062 in.) or greater in diameter (D) or width(W) shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge lengthmust be reported with the test results. The method for determining elongation ofmaterial under 1.575 mm (0
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