1、Designation: F1295 11Standard Specification forWrought Titanium-6Aluminum-7Niobium Alloy for SurgicalImplant Applications (UNS R56700)1This standard is issued under the fixed designation F1295; the number immediately following the designation indicates the year oforiginal adoption or, in the case of
2、 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 the chemical, mechanical, andmetallurgical requirements for wrought
3、annealed, cold-worked,or hot-worked titanium-6aluminum-7niobium alloy bar, wire,sheet, strip, and plate to be used in the manufacture of surgicalimplants (1-4).21.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard. The values stated ineach system may
4、not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.2. Referenced Documents2.1 ASTM Standards:3E8/E8M Test Methods for Tension Testing of MetallicMaterialsE29 Practice for Using
5、Significant Digits in Test Data toDetermine Conformance with SpecificationsE290 Test Methods for Bend Testing of Material for Duc-tilityE1409 Test Method for Determination of Oxygen andNitrogen in Titanium and Titanium Alloys by the Inert GasFusion TechniqueE1447 Test Method for Determination of Hyd
6、rogen inTitanium and Titanium Alloys by Inert Gas Fusion Ther-mal Conductivity/Infrared Detection MethodE1941 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 Emiss
7、ion Plasma SpectrometryE2626 Guide for Spectrometric Analysis of Reactive andRefractory MetalsSI 10 American National Standard for Use of the Interna-tional System of units (SI): The Modern Metric System2.2 Aerospace Material Specification:4AMS 2249 Chemical Check Analysis Limits, Titanium andTitani
8、um AlloysAMS 2630 Inspection, Ultrasonic Product Over 0.5 Inch(12.7 mm) ThickAMS 2631 Ultrasonic Inspection-Titanium and TitaniumAlloy Bar and Billet2.3 ISO Standards:5ISO 583211 Implants for SurgeryMetallic MaterialsPart 11: Wrought Titanium 6Aluminum 7Niobium Al-loyISO 6892 Metallic MaterialsTensi
9、le TestingPart 1:Method of Test at Room TemperatureISO 9001 Quality Management SystemsRequirements3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 beta transus, nthe minimum temperature at whichthe alpha plus beta phase can transform to 100 % beta phase.3.1.2 cold workany mecha
10、nical deformation process per-formed below the recrystallization temperature which results instrain hardening of the material.3.1.3 lot, nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.3.1.4 hot workany mechanical deformation
11、 process per-formed above the recrystallization temperature.3.1.5 stress reliefthermal treatment that reduces the re-sidual stresses in the material without affecting the mechanicalproperties.4. Product Classification4.1 BarRounds, or flats, or other shapes from 0.188 in.(4.76 mm) to 4.0 in. (102 mm
12、) in diameter or thickness. Othersizes and shapes by special order.1This 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 Materials.Current edition approved Nov. 15, 2011
13、. Published December 2011. Originallyapproved in 1992. Last previous edition approved in 2005 as F1295 05. DOI:10.1520/F1295-11.2The boldface numbers in parentheses refer to a list of references at the end ofthe text.3For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact AST
14、M Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.4Available from SAE International (SAE), 400 Commonwealth Dr., Warrendale,PA 15096-0001, http:/www.sae.org.5Available from American National Sta
15、ndards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.2 Forging BarBar as describ
16、ed in 4.1, used in theproduction of forgings. This product may be furnished in thehot-worked condition.4.3 WireRounds, flats, or other shapes less than 0.188 in.(4.76 mm) in diameter or thickness.4.4 StripAny product 0.188 in. (4.76 mm) and under inthickness and less than 24 in. (610 mm) in width.4.
17、5 SheetAny product 0.188 in. (4.76 mm) and under inthickness and 24 in. (610 mm) or more in width.4.6 PlateAny product 0.188 in (4.76 mm) thick and over10 in. (254 mm) wide and over, with widths greater than fivetimes thickness. Plate up to 4 in. (101.60 mm), thick inclusiveis covered by this specif
18、ication.5. Ordering Information5.1 Include with inquiries and orders for material under thisspecification the following information:5.1.1 Quantity (weight or number of pieces),5.1.2 Applicable ASTM designation, date of issue.5.1.3 Form (bar, wire, sheet, strip, or plate),5.1.4 Condition (see 6.2),5.
19、1.5 Mechanical Properties (if applicable for special con-ditions),5.1.6 Finish (see 6.1),5.1.7 Applicable dimensions including size, thickness,width, or drawing number,5.1.8 Special tests, if any,5.1.9 Other requirements.6. Materials and Manufacture6.1 FinishThe mill product may be supplied as speci
20、fiedby the purchaser with a descaled or pickled, abrasive-blasted,chemically milled, ground, machined, peeled, or polishedfinish.6.2 ConditionMaterial shall be furnished in the annealed,cold-worked, or hot-worked condition. The purchaser shallinclude on drawings or purchase orders whether the materi
21、alshall be stress-relieved.7. Chemical Requirements7.1 The heat analysis shall conform to the chemical com-position of Table 1. Ingot analysis may be used for reporting allchemical requirements, except hydrogen. Samples for hydro-gen shall be taken from the finished mill product. The suppliershall n
22、ot ship material with chemistry outside the requirementsspecified in Table 1.7.1.1 Requirements for the major and minor elementalconstituents are listed in Table 1. Also listed are importantresidual elements. Analysis for elements not listed in Table 1 isnot required to certify compliance with this
23、specification.7.2 Product Analysis:7.2.1 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 2.7.2.2 The pr
24、oduct analysis is either for the purpose ofverifying the composition of a heat or manufacturing lot or todetermine variations in the composition within the heat.7.2.3 Acceptance or rejection of a heat or manufacturing lotof material may be made by the purchaser on the basis of thisproduct analysis.
25、Product analysis outside the tolerance limitsallowed in Table 2 are cause for rejection of the product. Areferee analysis may be used if agreed by supplier andpurchaser.7.3 For referee purposes, use Test Methods E1409, E1447,E1941, E2371, and E2626 or other analytical methods agreedupon between the
26、purchaser and the supplier.7.4 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 such as oxygen, nitrogen, and hydrogen. Incutting samples for analysis, therefo
27、re, 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 material supplied under this specification shallconform to the mechanical proper
28、ties given in Table 3.Alternative properties may be agreed upon between the pur-chaser and supplier.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 0.007in./in./min (mm/mm/min) t
29、hrough the specified yield and thenthe crosshead speed shall be increased so as to produce fracturein approximately one additional minute.8.2.1 Bar, Forging Bar, and WireTest according to TestMethods E8/E8M.8.2.2 Tensile tests result for which any specimen fracturesoutside the gauge length shall be
30、considered valid, if both theTABLE 1 Chemical RequirementsElement Composition, %Aluminum 5.50 to 6.50Niobium 6.50 to 7.50Tantalum 0.50 maxIron 0.25 maxOxygen 0.20 maxCarbon 0.08 maxNitrogen 0.05 maxHydrogen 0.009 maxTitaniumABalanceAThe percentage of titanium is determined by difference and need not
31、 bedetermined or certified.TABLE 2 Product Analysis TolerancesATolerance Under the MinimumBor Over the Maximum LimitAluminum 0.10Niobium 0.10Tantalum 0.10Iron 0.10Oxygen 0.02Carbon 0.02Nitrogen 0.02Hydrogen 0.002ARefer to AMS 2249.BUnder minimum limit not applicable for elements where only a maximum
32、percentage is indicated.F1295 112elongation 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.8.2.3 Should any test sp
33、ecimen not meet the specifiedrequirements, test two additional test pieces representative ofthe same lot, in the same manner, for each failed test specimen.The lot will be considered in compliance only if all additionaltest pieces meet the specified requirements.8.3 Sheet, Strip, and Plate:8.3.1 Tes
34、t according to Test Methods E8/E8M. Perform atleast one tensile test from each lot in both the longitudinal andtransverse directions. Tests in the transverse direction need bemade only on product from which a specimen not less than 8.0in. (200 mm) in length for strip can be taken. Should any ofthese
35、 test specimens not meet the specified requirements, testtwo additional test pieces representative of the same lot, in thesame manner, for each failed test specimen. The lot will beconsidered in compliance only if all additional test pieces meetthe specified requirements.8.3.2 For sheet and strip, t
36、he bend test specimen shallwithstand being bent cold through an angle of 105 withoutfracture in the outside surface of the bent portion. The bendshall be made around a mandrel which has a diameter equal tothat shown in Table 4. Test conditions shall conform to TestMethod E290.9. Dimensions and Permi
37、ssible Variations9.1 Units of Measure:9.1.1 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 severa
38、l alternate forms listed in order ofprecedence.9.1.1.1 If the purchaser and supplier have a history of usingspecific units, these units shall continue to be certified untilexpressly changed by the purchaser.9.1.1.2 In the absence of historic precedence, if the unitsused to define the product on the
39、purchasers PO, specification,and engineering drawing are consistent, these units shall beused by the supplier for product certification9.1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between purchaser andsupplier.9.1.2 Conversion of UnitsIf the suppl
40、iers test equipmentdoes 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 f
41、or the use of SIunits. Annex A provides conversion tables and Annex Bprovides rules for conversion and significance.10. Special Requirements10.1 The microstructure shall be a fine dispersion of thealpha and beta phases resulting from processing in the alphaplus beta field. There shall be no continuo
42、us alpha network atprior beta grain boundaries. There shall be no coarse, elongatedalpha platelets.10.2 Determine the beta transus temperature for each heatby a suitable method and report on the material certification ifrequired by the purchaser.TABLE 3 Mechanical Properties for Bar and WireConditio
43、nAUltimate Tensile Strength,min, psi, (MPa)Yield Strength (0.2 %Offset), min, psi, (MPa)Elongation,Bmin, %Reductionof Area,min, %Annealed 130 500 (900) 116 000 (800) 10 25Hot Worked 130 500 (900) 116 000 (800) 10 25Cold Worked 159 500 (1100) 116 000 (800) 10 25AMechanical properties for conditions o
44、ther than those listed in this table may be established by agreement between the supplier and purchaser.BElongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or thickness (T) shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge lengthmust be reported with the test r
45、esults. The method for determining elongation of material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated.Alternatively,a gauge length of 5.65 times the square root of So, where So is the original cross-sectional area corresponding to ISO 6892 may be used when agreed upon between
46、supplier and purchaser.TABLE 4 Mechanical Properties for Sheet, Strip, and PlateConditionAUltimate Tensile Strengthmin, psi (MPa)Yield Strength (0.2 % offset),min, psi (MPa)ElongationBin 2 in. (50 mm),min %Bend Test Mandrel DiameterCUnder 0.070 in.(1.78 mm)in Thickness0.070 to 0.188 in.(1.78to4.76mm
47、)in ThicknessAnnealed 130 500(900)130 500(900)10 9T 10TAMechanical properties for conditions other than those listed in this table may be established by agreement between the supplier and purchaser.BElongation of material 0.063 inches (1.6 mm) or greater in thickness shall be measured using a gauge
48、length of 2 inches (50 mm). The gauge length must be reportedwith the test results. The method for determining elongation of material under 0.063 inches (1.6 mm) in thickness may be negotiated. Alternatively, a gauge lengthcorresponding to ISO 6892 may be used when agreed upon between supplier and p
49、urchaser. (5.65 times the square root of So, where So is the original cross sectionalarea.) Gauge length will be reported with the elongation value.CT equals the thickness of the bend test specimen. Bend tests are not applicable to material over 0.188 in. (4.76 mm) in thickness. The limits listed apply to tests takenboth longitudinal and transverse to the direction of rolling.F1295 11310.3 Alpha case is not permitted for products supplied witha machined, ground, or chemically milled surface finish. Forother products, there shall be no continuous laye
