1、Designation: F3046 13Standard Specification forWrought Titanium-3Aluminum-2.5Vanadium Alloy forSurgical Implant Applications (UNS R56320)1This standard is issued under the fixed designation F3046; the number immediately following the designation indicates the year oforiginal adoption or, in the case
2、 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 wrough
3、t titanium-3aluminum-2.5vanadium alloy (R56320) to be used in the manufacture ofsurgical implants.1.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard. The values stated ineach system may not be exact equivalents; therefore, eachsystem shall be used i
4、ndependently of the other. Combiningvalues of the two systems may result in nonconformancewithin the standard.2. Referenced Documents2.1 ASTM Standards:2E8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with S
5、pecificationsE290 Test Methods for Bend Testing of Material for Ductil-ityE539 Test Method 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
6、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 Direct
7、Current Plasma and Inductively CoupledPlasma Atomic Emission Spectrometry (Performance-Based Test Methodology)2.2 ISO Standards:3ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management Systems Requirements2.3 ASQ Standard:4ASQ C1 Specifications of General Require
8、ments for a Qual-ity Control Program2.4 Aerospace Material Specifications:5AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium AlloysAMS 2631 Ultrasonic InspectionTitanium and TitaniumAlloy Bar and Billet3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 beta transus, n
9、the minimum temperature at whichthe alpha plus beta phase can transform to 100 % beta phase.3.1.2 lot, nthe total number of mill products producedfrom one heat under the same conditions at essentially the sametime.4. Product Classification4.1 StripAny product under 4.75 mm (0.1875 in.) inthickness a
10、nd under 610 mm (24 in.) wide.4.2 SheetAny product under 4.75 mm (0.1875 in.) inthickness and 610 mm (24 in.) or more in width.4.3 PlateAny product 4.75 mm (0.1875 in.) thick andover and 250 mm (10 in.) wide and over, with widths greaterthan five times thickness. Plate up to 101.60 mm (4.00 in.),thi
11、ck inclusive is covered by this specification.4.4 BarRound bars and flats from 4.75 mm (0.1875 in.) to101.60 mm (4.00 in.) in diameter or thickness (other sizes andshapes by special order).1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices a
12、nd is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Dec. 1, 2013. Published January 2014. DOI: 10.1520/F3046-13.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual B
13、ook 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 for Quality (ASQ), 600 N. Plankinto
14、n Ave.,Milwaukee, WI 53203, http:/www.asq.org.5Available from SAE International (SAE), 400 Commonwealth Dr., Warrendale,PA 15096-0001, http:/www.sae.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14.5 Forging BarBar as described i
15、n 4.4, used for produc-tion of forgings, may be furnished in the hot worked condition.4.6 WireRounds, flats, or other shapes less than 4.75 mm(0.1875 in.) in diameter.4.7 OtherOther forms and shapes may be provided byagreement between purchaser and supplier.5. Ordering Information5.1 Include with in
16、quiries and orders for material under thisspecification the following information:5.1.1 Quantity,5.1.2 ASTM designation and date of issue,5.1.3 Form (sheet, strip, plate, bar, forging bar, or wire),5.1.4 Condition (see section 6.3),5.1.5 Mechanical properties (if applicable, for specialconditions),5
17、.1.6 Finish (see section 6.2),5.1.7 Applicable dimensions including size, thickness,width, length, or drawing number,5.1.8 Special tests, if any, and5.1.9 Other requirements.6. Materials and Manufacture6.1 The various titanium mill products covered in thisspecification normally are formed with the c
18、onventional forg-ing and rolling equipment found in primary ferrous andnonferrous plants. The alloy is usually multiple melted in arcfurnaces (including furnaces such as plasma arc and electronbeam) of a type conventionally used for reactive metals.6.2 FinishThe mill product may be furnished to thei
19、mplant manufacturer as mechanically descaled or pickled,abrasively blasted, chemically milled, ground, machined,peeled, polished, combinations of these operations, or asspecified by the purchaser. On billets, bars, plates, andforgings, it is permissible to remove minor surface imperfec-tions by grin
20、ding if the resultant area meets the dimensionaland surface finish requirements of this specification.6.3 ConditionMaterial shall be furnished in the annealedor cold-worked condition. Mechanical properties for condi-tions other than those listed in Table 1 may be established byagreement between the
21、supplier and the purchaser.7. Chemical Requirements7.1 The heat analysis shall conform to the chemical com-position specified in Table 2. Ingot analysis may be used forreporting all chemical requirements, except hydrogen. Samplesfor hydrogen shall be taken from the finished mill product. Thesupplier
22、 shall not ship material with chemistry outside therequirements specified in Table 2.7.1.1 Requirements for the major and minor elementalconstituents are listed in Table 2. Also listed are importantresidual elements.Analysis for elements not listed in Table 2 isnot required to verify compliance with
23、 this specification.7.2 Product Analysis:7.2.1 Product analysis tolerances do not broaden the speci-fied heat analysis requirements but cover variations betweenlaboratories in the measurement of chemical content. Theproduct analysis tolerances shall conform to the producttolerances in Table 3.7.2.2
24、The product analysis is either for the purpose ofverifying the composition of a heat or manufacturing lot ordetermining variations in the composition within the heat.TABLE 1 Annealed Mechanical Properties of Sheet, Strip, Plate, Bar, Wire, and ForgingsNominal Diameteror Distance BetweenParallel Side
25、s, mm (in.)Tensile Strengthmin,MPa (psi)Yield Strength(0.2 % offset) min,MPa (psi)ElongationAin 50 mm (2 in.),min, %Reduction of AreaBmin, %Under 4.75 (0.1875)thickness or diameter620 (90 000) 485 (70 000) 15 .4.75 (0.1875) to101.60 (4.00), incl620 (90 000) 485 (70 000) 15 25AElongation of material
26、1.6 mm (0.063 in.) greater width (W) shall be measured using a gage length of 50 mm. or 4 W. The gage length must be reported with the testresults. The method for determining elongation of material less than 1.6 mm (0.063 in.) in thickness may be negotiated. Alternatively, a gage length correspondin
27、g to ISO6892 may be used when agreed upon between supplier and purchaser. (5.65 times the square root of So, where So is the original cross sectional area.) Gage length shallbe reported with the elongation value.BApplies to plate only.TABLE 2 Chemical RequirementsElementComposition, %(mass/mass)Nitr
28、ogen, max 003Carbon, max 0.08Hydrogen, max 0.015Iron, max 0.25Oxygen, max 0.15Aluminum 2.503.50Vanadium 2.003.00TitaniumABalanceAThe percentage of titanium is determined by difference and need not bedetermined or certified.TABLE 3 Product Analysis ToleranceAElementTolerance Under the Minimum orOver
29、the Maximum LimitB% (mass/mass)Nitrogen 0.02Carbon 0.02Hydrogen 0.0020Iron 0.10Oxygen 0.02Aluminum 0.40Vanadium 0.15ASee AMS 2249.BUnder minimum limit not applicable for elements where only a minimumpercentage is indicated.F3046 1327.2.3 Acceptance or rejection of a heat or manufacturing lotof mater
30、ial may be made by the purchaser on the basis of thisproduct analysis. Product analysis outside the tolerance limitsallowed in Table 3 is cause for rejection of the product. Areferee analysis may be used if agreed upon by the supplier andpurchaser.7.2.4 For referee purposes, use Test Methods E539, E
31、1409,E1447, E1941, and E2371 or other analytical methods agreedupon between the purchaser and the supplier.7.3 Samples for chemical analysis shall be representative ofthe material being tested. The utmost care must be used insampling titanium for chemical analysis because of its affinityfor elements
32、 such as oxygen, nitrogen, and hydrogen. Incutting samples for analysis, therefore, the operation should becarried out insofar as possible in a dust-free atmosphere.Cutting tools should be clean and sharp. Samples for analysisshould be stored in suitable containers.8. Mechanical Requirements8.1 The
33、material supplied under this specification shallconform to the mechanical property requirements in Table 1.8.2 Specimens for tension tests shall be machined and testedin accordance with Test Methods E8/E8M. Tensile propertiesshall be determined using a strain rate of 0.003 to 0.007mm/mm/min (in./in.
34、/min) through yield and then the crossheadspeed may be increased so as to produce fracture in approxi-mately one additional minute.8.2.1 Bar, Forging Bar, Shapes, and WireTest accordingto Test Methods E8/E8M. Should any test specimen not meetthe specified requirements, test two additional test piece
35、srepresentative of the same lot, in the same manner, for eachfailed test specimen. The lot will be considered in complianceonly if all additional test pieces meet the specified require-ments.8.2.2 Tensile tests results for which any specimen fracturesoutside the gage length shall be considered accep
36、table, if boththe elongation and reduction of area meet the minimumrequirements specified. Refer to subsections 7.11.4 and 7.12.5of Test Methods E8/E8M. If either the elongation or reductionof area is less than the minimum requirement, discard the testand retest. Retest one specimen for each specime
37、n that did notmeet the minimum requirements.8.3 For sheet and strip, the bend test specimen shall with-stand being bent cold through an angle of 105 without fracturein the outside surface of the bent portion. The bend shall bemade around a mandrel which has a diameter equal to thatshown in Table 2.T
38、est conditions shall conform toTest MethodE290.8.3.1 Sheet, Strip, and PlateTest according to Test Meth-ods E8/E8M. Perform at least one tensile test from each lot inboth the longitudinal and transverse directions. Tests in thetransverse direction need be made only on product from whicha specimen no
39、t less than 200 mm (8 in.) in length for sheet and65 mm (2.50 in.) in length for plate can be taken. Should anyof these test specimens not meet the specified requirements,test two additional test pieces representative of the same lot, inthe same manner, for each failed test specimen. The lot will be
40、considered in compliance only if all additional test pieces meetthe specified requirements.9. Special Requirements9.1 The microstructure shall be a result of processing withinthe alpha-plus beta field. Microstructure shall essentially con-sist of an equiaxed and/or elongated primary alpha in atransf
41、ormed beta matrix with no continuous alpha network atprior beta grain boundaries.9.2 Determine the beta transus temperature for each heat bya suitable method and report on the material certification ifrequired by the purchaser.9.3 Alpha case is not permitted for products supplied with amachined, gro
42、und, or chemically milled or pickled surfacefinish. For other products, there shall be no continuous layer ofalpha case 0.0025 mm ( 0.001 in.) when examined at 100magnification.10. Ultrasonic Inspection10.1 All centerless ground or peeled and polished round bar 9.5 mm (0.375 in.) in nominal diameter
43、 shall be ultrasoni-cally inspected at final diameter according toAMS 2631, ClassA1. Equivalent test methods may be substituted when agreedupon by purchaser and supplier.NOTE 1AMS 2631 contains varying flat bottom hole (FBH) require-ments based on melting grades per AMS 2380. Since the FBH require-m
44、ents for Class 1 is the same, regardless of the melting grade, it is notnecessary to specify the melting grade.11. Significance of Numerical Limits11.1 The following applies to all specified numerical limitsin this specification. To determine conformance to these limits,an observed or calculated val
45、ue shall be rounded to the nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.12. Certification12.1 The supplier shall provide a certification that thematerial was tested in accordance with this specification. Are
46、port of the test results shall be furnished to the purchaser atthe time of shipment.13. Quality Program Requirements13.1 The producer shall maintain a quality program asdefined in ASQ C1, ISO 9001, or similar quality program.14. Keywords14.1 metals (for surgical implants); orthopedic medicaldevices;
47、 titanium alloys; titanium alloys (for surgical implants)F3046 133APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thechemical, physical, mechanical, and metallurgical properties ofwrought annealed titanium-3aluminum-2.5vanadium alloy tobe us
48、ed in the manufacture of surgical implants.X1.2 The microstructural requirements contained in thisspecification represent the current general consensus of opinionwith respect to optimization of mechanical properties forimplant applications.X1.3 The minimum mechanical properties specified ensurea bas
49、eline of strength and ductility for the highly stresseddevices for which this alloy is typically used.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this specificationhas been employed successfully in human implant applicationsin contact with soft tissue and bone for over a decade.X2.2 No known surgical implant material has ever beenshown to be completely free from adverse reactions in thehuman body. Long-term clinical experience of the use of thematerial referred to in this specification, however, has shownthat an acceptable level of biological
