1、Designation: F 1472 08Standard 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 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. Scope*1.1 This specification covers the chemical, mechanical, andmetallurgical requirements for wroug
3、ht 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 mathematicalconversions to SI units that are provided for information onlyand are
4、 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 SpecificationsE 290 Test Methods for Bend Testing of Material forDuctilityE 527 Practice fo
5、r 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 Determination of Hydrogen inTitanium and Titanium Alloys by the Inert Gas FusionThermal
6、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 Program2.3 Aerospace Material Specifications:4AMS 2249 Chemical Check Analysis Limit
7、s, 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, Forgings, and Rings6.0Al-4.0V Solution Heat Treated and Aged2.4 ISO Standards:5ISO 58233
8、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 Metals and Alloys(UNS)3. Terminology3.1 Definitions of Terms Specific to This Stand
9、ard: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 24 in. (610 mm) wide.4.2 SheetAny product under 0.188 in. (4.76 mm) inthickness an
10、d 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, is covered by this specification.4.4 BarRound bars and flats from 0.188 in. (4.76
11、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 direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition
12、 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 Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume informat
13、ion, 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 Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.
14、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 Changes section appears at the end of this standard.Copyright ASTM International, 100
15、Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Copyright by ASTM Intl (all rights reserved); Mon Nov 3 21:40:02 EST 2008Downloaded/printed byGuo Dehua (CNIS) pursuant to License Agreement. No further reproductions authorized.4.5 Forging BarBar as described in 4.4, us
16、ed in theproduction of forgings. This product may be furnished in thehot worked condition.4.6 WireRounds, 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 infor
17、mation:5.1.1 Quantity,5.1.2 ASTM designation and date of issue,5.1.3 Form (strip, sheet, plate, 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
18、, 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 conventional forg-ing and rolling equipment found in primary ferrous andnonferrous plants.
19、 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 thepurchaser as mechanically descaled or pickled, sandblasted,chemically milled, ground, mach
20、ined, peeled, polished, com-binations of these operations, or as specified by the purchaser.On billets, 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 C
21、onditionMaterial shall be furnished in the annealedor cold-worked condition.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 fr
22、om the finished mill product. Supplier shallnot 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 is
23、not required to verify compliance with this 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 t
24、he producttolerances in Table 2.7.2.2 The product analysis is either for the purpose ofverifying 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 p
25、urchaser on the basis of thisproduct analysis. Product analyses outside the tolerance limitsallowed 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
26、analytical methods agreed uponbetween 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 such as oxygen, nitrogen, and hydroge
27、n. 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 material supplied under this specifica
28、tion shallconform to the mechanical property requirements 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. Tensile properties shallbe determined using a strain rate
29、 of 0.003 to 0.007 in./in./min(mm/mm/min) through yield and then the crosshead speed maybe increased 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
30、 surface of the bent portion. The bend shall beTABLE 1 Chemical RequirementsAElement Composition, %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
31、.01 % hydrogen content.CThe percentage of titanium is determined by difference and need not bedetermined 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 0.40V
32、anadium 0.15Yttrium 0.0006ASee AMS 2249.BUnder minimum limit not applicable for elements where only a minimumpercentage is indicated.F1472082Copyright by ASTM Intl (all rights reserved); Mon Nov 3 21:40:02 EST 2008Downloaded/printed byGuo Dehua (CNIS) pursuant to License Agreement. No further reprod
33、uctions authorized.made 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.Should any of these test s
34、pecimens 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 Tensile tests results for wh
35、ich 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 than the minimum requireme
36、nt, 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 the longitudinal andtransvers
37、e 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, test two additional test piece
38、srepresentative 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 alphaand beta phases result
39、ing 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 material certification ifrequir
40、ed 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 Limits10.1 The following applies
41、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 method ofPractice E29.11. Certi
42、fication11.1 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 The supplier shall maintain
43、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 DistanceBetween Parallel Sides,in. (m
44、m)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 to 100), incl 130 000 (895)
45、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 . . . . .0.025 to 0.063 (0.6 to 1.6), e
46、xcl 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 0.1875 (4.8), excl bend facto
47、rG= 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 material 0.062 in. (1.575 mm) or
48、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 = short transverse.ETransve
49、rse 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 and strip products: T = thickness of bend specimen in reference to diameter of bend. (Bend factor is the mandrel diameter.)F1472083Copyright by ASTM Intl (all rights reserved); Mon Nov 3 21:40:02 EST 2008Downloaded/printed byGuo Dehua (CNIS) pursuant to License Agreement. No further reproduc
