1、Designation: F 1472 081Standard Specification forWrought Titanium-6Aluminum-4Vanadium Alloy for SurgicalImplant Applications (UNS R56400)1This standard is issued under the fixed designation F 1472; the number immediately following the designation indicates the year oforiginal adoption or, in the cas
2、e 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.1NOTEEditorially corrected the ISO 58323 designation throughout in December 2008.1. Scope*1.1 This spec
3、ification covers the chemical, mechanical, andmetallurgical requirements for wrought annealed titanium-6aluminum-4vanadium alloy (UNS R56400) to be used in themanufacture of surgical implants.1.2 The values stated in inch-pound units are to be regardedas standard. The values given in parentheses are
4、 mathematicalconversions to SI units that are provided for information onlyand are not considered standard.2. Referenced Documents2.1 ASTM Standards:2E8 Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with Specifica
5、tionsE 290 Test Methods for Bend Testing of Material forDuctilityE 527 Practice for Numbering Metals and Alloys in theUnified Numbering System (UNS)E 1409 Test Method for Determination of Oxygen andNitrogen in Titanium and Titanium Alloys by the Inert GasFusion TechniqueE 1447 Test Method for Determ
6、ination of Hydrogen inTitanium and Titanium Alloys by the Inert Gas FusionThermal Conductivity/Infrared Detection MethodE 2371 Test Method for Analysis of Titanium and TitaniumAlloys by Atomic Emission Plasma Spectrometry2.2 ASQ Standard:3ASQ C1 Specifications of General Requirements for aQuality Pr
7、ogram2.3 Aerospace Material Specifications:4AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium AlloysAMS 4911 Titanium Alloy Sheet, Strip, and Plate 6Al-4VAnnealedAMS 4928 TitaniumAlloy Bars, Wire, Forgings, Rings, andDrawn Shapes 6Al-4V AnnealedAMS 4965 TitaniumAlloy, Bars, Wire, Forging
8、s, and Rings6.0Al-4.0V Solution Heat Treated and Aged2.4 ISO Standards:5ISO 58323 Implants for SurgeryMetallic MaterialsPart 3, Wrought Titanium-6Aluminum-4Vanadium AlloyISO 9001 Quality Management SystemsRequirements2.5 Society of Automotive Engineers Standard:4, 6SAE J1086 Practice for Numbering M
9、etals and Alloys(UNS)3. Terminology3.1 Definitions of Terms Specific to This Standard:3.2 lot, nthe total number of mill products produced fromone heat under the same conditions at essentially the sametime.4. Product Classification4.1 StripAny product under 0.188 in. (4.76 mm) inthickness and under
10、24 in. (610 mm) wide.4.2 SheetAny product under 0.188 in. (4.76 mm) inthickness and 24 in. (610 mm) or more in width.4.3 PlateAny product 0.188 in. (4.76 mm) thick and overand 10 in. (254 mm) wide and over, with widths greater thanfive times thickness. Plate up to 4.00 in. (102 mm) thick,inclusive,
11、is covered by this specification.4.4 BarRound bars and flats from 0.188 in. (4.76 mm) to4.00 in. (102 mm) in diameter or thickness (other sizes andshapes by special order).1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the dire
12、ct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Oct. 1, 2008. Published October 2008. Originallypublished in 1993. Last previous edition approved in 2002 as F 1472 02a.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Cus
13、tomer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.4Available from Society of Automoti
14、ve Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.6New designation established in accordance with E 527 and SAE J1086.1*A Summary of Chan
15、ges 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.4.5 Forging BarBar as described in 4.4, used in theproduction of forgings. This product may be furnished in thehot worked condition.4.6 Wi
16、reRounds, flats, or other shapes less than 0.188 in.(4.76 mm) in diameter or thickness.5. Ordering Information5.1 Include with inquiries 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 (strip, sheet, plate,
17、bar, forging bar, or wire),5.1.4 Condition (see 6.3),5.1.5 Mechanical properties (if applicable, for special con-ditions),5.1.6 Finish (see 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. Material
18、s and Manufacture6.1 The various titanium mill products covered in thisspecification normally are formed with the conventional 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
19、electronbeam) of a type conventionally used for reactive metals.6.2 FinishThe mill product may be furnished to thepurchaser as mechanically descaled or pickled, sandblasted,chemically milled, ground, machined, peeled, polished, com-binations of these operations, or as specified by the purchaser.On b
20、illets, bars, plates, and forgings, it is permissible toremove minor surface imperfections by grinding if the resultantarea meets the dimensional and surface finish requirements ofthis specification.6.3 ConditionMaterial shall be furnished in the annealedor cold-worked condition.7. Chemical Requirem
21、ents7.1 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. Supplier shallnot ship material with chemistry outside the require
22、mentsspecified 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 verify compliance with this specification.7.2 Product Analysis:7.2.1 Product ana
23、lysis 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 product analysis is either for the purpose ofverifying
24、 the composition of a heat or manufacturing lot or fordetermining 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. Product analyses outside the tolerance limitsallo
25、wed in Table 2 are cause for rejection of the product. Areferee analysis may be used if agreed upon by supplier andpurchaser.7.2.4 For referee purposes, use Test Methods E1409,E 1447, and E 2371 or other analytical methods agreed uponbetween the purchaser and the supplier.7.3 Samples for chemical an
26、alysis 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, therefore, the operation should becarried out insofar as poss
27、ible 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 property requirements in Table 3.Alternative properties may
28、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. Tensile properties shallbe determined using a strain rate of 0.003 to 0.007 in./in./min(mm/mm/min) through yield and then the crosshead speed maybe incre
29、ased so as to produce fracture in approximately oneadditional minute.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 beTABLE 1 Chemical RequirementsAElement Composition
30、, %Nitrogen, max 0.05Carbon, max 0.08Hydrogen, maxB0.015Iron, max 0.30Oxygen, max 0.20Aluminum 5.56.75Vanadium 3.54.5Yttrium, max 0.005TitaniumCbalanceARefer to AMS 4928.BBillets shall have a maximum of 0.01 % hydrogen content.CThe percentage of titanium is determined by difference and need not bede
31、termined or certified.TABLE 2 Product Analysis ToleranceAElementTolerance Under the Minimum orOver the Maximum Limit(Composition %)BNitrogen 0.02Carbon 0.02Hydrogen 0.002Iron 0.10Oxygen 0.02Aluminum 0.40Vanadium 0.15Yttrium 0.0006ASee AMS 2249.BUnder minimum limit not applicable for elements where o
32、nly a minimumpercentage is indicated.F14720812made over a mandrel with a diameter equal to that shown inTable 3. Test conditions shall conform to Test Method E 290.8.4 Number of Tests:8.4.1 Bar, Forging Bar, Shapes, and WirePerform at leastone tension test from each lot in the longitudinal direction
33、.Should any of these test specimens 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 both additionaltest pieces meet the specified requirements.8.4.2 T
34、ensile tests results for which any specimen fracturesoutside the gage length shall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequirements specified. Refer to Sections 7.11.4 and 7.12.5 ofTest Methods E8. If either the elongation or reduction of areais less
35、 than the minimum requirement, discard the test andretest. Retest one specimen for each specimen that did not meetthe minimum requirements.8.4.3 Sheet, Strip, and PlatePerform at least one tensiontest from each lot in the longitudinal direction. Perform at leastone bend test from each lot in both th
36、e 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 sheet and 2.50 in. (64 mm) in lengthfor plate can be taken. Should any of these test pieces not meetthe specified requirements, tes
37、t two additional test piecesrepresentative of the same lot, in the same manner, for eachfailed test specimen. The lot shall be considered in complianceonly if both additional test pieces meet the specified require-ments.9. Special Requirements9.1 The microstructure shall be a fine dispersion of the
38、alphaand beta phases resulting from processing in the alpha plus betafield. There shall be no continuous alpha network at prior betagrain boundaries. There shall be no coarse, elongated alphaplatelets.9.2 Determine the beta transus temperature for each heat bya suitable method and report on the mate
39、rial certification ifrequired by the purchaser.9.3 Alpha case is not permitted for products supplied with amachined, ground, or chemically milled surface finish. Forother products, there will be no continuous layer of alpha casewhen examined at 1003 magnification.10. Significance of Numerical Limits
40、10.1 The following applies to all specified numerical limitsin this specification. To determine conformance to these limits,an observed or calculated value shall be rounded to the nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding meth
41、od ofPractice E29.11. Certification11.1 The supplier shall provide a certification that thematerial was tested in accordance with this specification andmet all requirements. A report of the test results shall befurnished to the purchaser at the time of shipment.12. Quality Program Requirements12.1 T
42、he supplier shall maintain a quality program such asdefined in ASQ C1, ISO 9001, or similar.13. Keywords13.1 metals (for surgical implants); orthopaedic medicaldevices; titanium alloys; titanium alloys (for surgical implants)TABLE 3 Annealed Mechanical PropertiesASize, Nominal Diameter or DistanceBe
43、tween Parallel Sides,in. (mm)Tensile Strength,Bpsi, (MPa), minYield Strength,Bat 0.2 % Offset,psi (MPa), minElongationCin 2 in. (50 mm),or 4D or 4T, %, minReduction of Area, %, minDLLTESTE,FLLTESTE,FBars and Forgings:Up to 2.0 (50), incl 135 000 (930) 125 000 (860) 10 . . 25 . .Over 2.0 to 4.0 (50 t
44、o 100), incl 130 000 (895) 120 000 (825) 10 10 10 25 20 15Over 4.0 to 6.0 (100 to 150), incl 130 000 (895) 120 000 (825) 10 10 8 20 15 15Sheet, Strip, and Plate:Up to 0.008 (0.2), excl 134 000 (924) 126 000 (869) . . . . . .0.008 to 0.025 (0.2 to 0.6), excl 134 000 (924) 126 000 (869) 6 . . . . .0.0
45、25 to 0.063 (0.6 to 1.6), excl 134 000 (924) 126 000 (869) 8 . . . . .0.063 to 0.1875 (1.6 to 4.8), excl 134 000 (924) 126 000 (869) 10 . . . . .0.1875 to 4.00 (4.8 to 101.6), incl 130 000 (895) 120 000 (825) 10 10 10 20 20 15Bending Parameters:Up to 0.07 (1.875), incl bend factorG=9TOver 0.07 to 0.
46、1875 (4.8), excl bend factorG= 10TAMechanical properties for conditions other than those listed in this table may be established by agreement between the supplier and the purchaser.BTensile and yield strength requirements apply in both the longitudinal and transverse directions.CElongation of materi
47、al 0.062 in. (1.575 mm) or greater in diameter or thickness shall be measured using a gage length of 2 in. or 4D or 4T. Elongation of material under0.062 in. in diameter or thickness may be obtained by negotiation.DApplies to bar, plate, and forgings only. L = longitudinal; LT = long transverse; ST
48、= short transverse.ETransverse requirements in Table 3 apply only to product from which a tensile specimen not less than 2.50 in. (63.5 mm) in length can be obtained.FMaterial tested in the short transverse direction need not be tested in the long transverse direction.GBend test applicable to sheet
49、and strip products: T = thickness of bend specimen in reference to diameter of bend. (Bend factor is the mandrel diameter.)F14720813APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thechemical, physical, mechanical, and metallurgical properties ofwrought annealed titanium-6aluminum-4vanadium alloy to beused in the manufacture of surgical implants.X1.2 The alloy composition covered by this specificationhas been used successfully in human implants, exhibiting awell-characterized level of local biologi
