ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications.pdf

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1、Designation: F2885 17Standard 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. Scope*1.1 This specification covers chemical, mechanical, andmetallurgical requirements for two

3、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 UnitsThe values in either

4、inch-pound or SI are to beregarded separately as standard. The values stated in eachsystem may not be exact equivalents; therefore, each systemshall be used independent of the other. Combining values fromthe two systems may result in non-conformance with thespecification.1.4 This standard does not p

5、urport 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, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international stan

6、dard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. R

7、eferenced 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 Metallogr

8、aphic 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 M

9、ethod forAnalysis ofTitaniumAlloys by X-RayFluorescence SpectrometryE1409 Test Method for Determination of Oxygen and Nitro-gen in Titanium and Titanium Alloys by Inert Gas FusionE1447 Test Method for Determination of Hydrogen in Tita-nium and Titanium Alloys by Inert Gas Fusion ThermalConductivity/

10、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 Direct Current Plasma and Inductively CoupledPlasma Atomic Emission Spectrometry (Performanc

11、e-Based Test Methodology)E2626 Guide for Spectrometric Analysis of Reactive andRefractory Metals (Withdrawn 2017)3F601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF629 Practice for Radiography of Cast Metallic SurgicalImplantsF1108 Specification for Titanium-6Aluminum

12、-4VanadiumAlloy Castings for Surgical Implants (UNS R56406)F1472 Specification for Wrought Titanium-6Aluminum-4VanadiumAlloy for Surgical ImplantApplications (UNSR56400)IEEE/ASTM SI 10 American National Standard for Use ofthe International System of Units (SI):The Modern MetricSystem1This specificat

13、ion 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 Sept. 1, 2017. Published October 2017. Originallyapproved in 2011. Last previous edition approve

14、d in 2011 as F2885 11. DOI:10.1520/F2885-17.2For 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 approve

15、d version of this historical standard is referenced onwww.astm.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 StatesThis international standard was developed in accordance

16、 with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.12.2 ISO Standards:4ISO 5832-3 Implant

17、s for SurgeryMetallic MaterialsPart3: Wrought Titanium 6-Aluminum 4-Vanadium AlloyThird EditionISO 6892 Metallic MaterialsTensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements2.3 Aerospace Material Specifications:5AMS 2249 Chemical Check Analysis Limits, Titanium andTi

18、tanium Alloys2.4 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 SpecimensSt

19、andard 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 Mater

20、ialSection of Vol. 02.05 of theAnnual Book ofASTM Standards.3.2 Definitions of Terms Specific to This Standard:3.2.1 absolute density, 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.

21、2.1.1 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 Method B923 will be used to represent theabsolute density of the particular chemical composition.3.2.2 debinding

22、, va step between molding and sinteringwhere the majority of the binder used in molding is extractedby heat, solvent, a catalyst or other techniques.3.2.3 feedstock, nin metal injection molding, a moldablemixture of metal powder and binder.3.2.4 feedstock batch, na specified quantity of feedstockmad

23、e up of the same lot of metallic powders and the same lotof binder materials mixed under the same conditions atessentially the same time.3.2.5 lot, na specified quantity of components made up ofthe same batch of feedstock, debound, sintered and postprocessed under the same conditions at essentially

24、the sametime.3.2.6 metal injection molded component, nproduct fabri-cated by a metal injection molding process consisting ofmixing metal powders with binders to make a feedstock,introducing this feedstock into a mold by injection or othermeans, debinding to remove the binders, and sintering.3.2.7 pr

25、e-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.3.2.8 relative density, nthe density ratio, often expressedas a percentage, of the density of a porous material to theabs

26、olute density of the same material, completely free ofporosity.3.2.9 sintering, vthe metallurgical bonding of particles ina MIM component resulting from a thermal treatment at atemperature below the melting point of the main constituent.4. Ordering Information4.1 Include with inquiries and orders fo

27、r material under thisspecification 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 Condi

28、tion (5.2),4.1.7 Mechanical 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

29、-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 compo-nent properties. The post sintering operations shall be agreedupon between the s

30、upplier and purchaser.5.3 Condition and finish of the components shall be agreedupon between the supplier and purchaser.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from American Society for Quality (ASQ), 6

31、00 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.6Available from Metal Powder Industries Federation (MPIF), 105 College Rd.East, Princeton, NJ 08540, http:/www.mpif.org.TABLE 1 Chemical CompositionComposition for both Type 1 and Type 2 AlloysElementComposition, % (Mass/Mass)min maxNitrog

32、en . 0.05Carbon . 0.08Hydrogen . 0.015Iron . 0.30Oxygen . 0.20Aluminum 5.5 6.75Vanadium 3.5 4.5Yttrium . 0.005TitaniumABalanceAApproximately equal to the difference of 100% and the sum of percentage of theother specified elements. The percentage of the Titanium difference is not requiredto be report

33、ed.F2885 1726. Chemical Requirements6.1 The components supplied under this specification shallconform to the chemical requirements in Table 1. Suppliershall not ship components with chemistry outside the require-ments specified in Table 1.6.1.1 Chemical analysis of a finished component or repre-sent

34、ative sample shall be used for reporting all chemicalrequirements. Any representative samples shall be producedfrom the same feedstock batch, debound, sintered, and postprocessed concurrently with the finished components theyrepresent.6.1.2 Requirements for the major and minor elementalconstituents

35、are listed in Table 1. Also listed are importantresidual elements. The percentage of Titanium is determinedby difference and need not be determined or certified.6.1.3 All commercial metals contain small amounts ofelements other than those which are specified. It is neitherpractical nor necessary to

36、specify limits for unspecifiedelements, whether residual elements or trace elements, that canbe present.The producer is permitted to analyze for unspecifiedelements and is permitted to report such analyses.The presenceof an unspecified element and the reporting of an analysis forthat element shall n

37、ot be a basis for rejection.Intentional elemental additions other than those specified inTable 1 are not permitted.6.1.4 Intentional elemental additions other than those speci-fied in Table 1 are not permitted.6.1.5 Analysis for elements not listed in Table 1 is notrequired to verify compliance with

38、 this specification.6.2 Product Analysis:6.2.1 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 producttolerances in Table 2.6.2.2

39、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 this product analyses.6.2.3 Sam

40、ples for chemical analysis shall be representativeof the component being tested. The utmost care must be usedin sampling titanium for chemical analysis because of itsaffinity for elements such as oxygen, nitrogen, and hydrogen.In cutting samples for analysis, therefore, the operation shouldbe carrie

41、d out insofar as possible in a dust-free atmosphere.Cutting tools should be clean and sharp. Samples for analysisshould be stored in suitable containers.6.2.4 Product analysis outside the tolerance limits allowedin Table 2 is cause for rejection of the product. A refereeanalysis may be used if agree

42、d upon by supplier and purchaser.6.2.5 For referee purposes, use Test Methods E539, E1409,E1447, E1941, 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 components supplied under this specif

43、icationshall 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 used if the component configuration is

44、such thata tensile specimen cannot be obtained from the component.7.2 Representative samples or molded tensile specimensshall be produced from the same feedstock batch, debound,sintered and post processed concurrently with finished compo-nents that they represent.7.2.1 Specimens machined from compon

45、ents or representa-tive samples shall be ground, or machined to final dimensionsin accordance with Test Methods 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 St

46、andard 10 and Standard 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 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 i

47、n approximately oneadditional minute.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 beTABLE 2 Product Analysis ToleranceAElementTolerance Under the MinimumorOver the Maximum Li

48、mitComposition (% 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 maximumpercentage is indicated.TABLE 3 Mechanical RequirementsType 1DensifiedType 2SinteredU

49、ltimate 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 (0.062 in.) in diameter or thickness may be negotiated.Alternatively, a ga