1、Designation: F 1472 02aStandard 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 (e) indicates an editorial change since the last revision or reapproval.1. Scope *1.1 This specification covers the chemical, mechanical, andmetallurgical requirements for wr
3、ought 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 the standard. The SI equivalents in parentheses are providedfor information only.2. Referenced Documents2.1 ASTM Standards:E
4、 8 Test Methods of Tension Testing of Metallic Materials2E 120 Test Methods for Chemical Analysis of Titanium andTitanium Alloys3E 290 Test Method for Bend Testing of Materials forDuctility2E 527 Practice for Numbering Metals and Alloys (UNS)4E 1409 Test Method for Determination of Oxygen in Tita-ni
5、um and Titanium Alloys by the Inert Gas Fusion Tech-nique3E 1447 Test Method for Determination of Hydrogen inTitanium and Titanium Alloys by the Inert Gas FusionThermal Conductivity Method5F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect of
6、Materials on Muscle and Bone62.2 ASQ Standard:C1 Specifications of General Requirements for a QualityProgram72.3 Aerospace Material Specifications:8AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium AlloysAMS 4911 Titanium Alloy Sheet, Strip, and Plate 6Al-4VAnnealedAMS 4928 Titanium Allo
7、y Bars, Wire, Forgings, Rings, andDrawn Shapes 6Al-4V AnnealedAMS 4965 Titanium Alloy, Bars, Wire, Forgings, and Rings6.0Al-4.0V Solution Heat Treated and Aged2.4 Society of Automotive Engineers Standard:SAE J1086 Practice for Numbering Metals and Alloys(UNS)93. Terminology3.1 Definitions of Terms S
8、pecific 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 0.1875 in. (4.75 mm) inthickness and under 24 in. (610 mm) wide.4.2 SheetAny product under 0.1875 in. (
9、4.75 mm) inthickness and 24 in. (610 mm) or more in width.4.3 PlateAny product 0.1875 in. (4.75 mm) thick andover and 10 in. (254 mm) wide and over, with widths greaterthan five times thickness. Plate up to 4.00 in. (101.60 mm)thick, inclusive, is covered by this specification.4.4 BarRound bars and
10、flats from 0.1875 in. (4.75 mm) to4.00 in. (101.60 mm) in diameter or thickness (other sizes andshapes by special order).4.5 Forging BarBar as described in 4.4, used for produc-tion of forgings, may be furnished in the hot rolled condition.4.6 WireRounds or flats less than 0.1875 in. (4.75 mm) india
11、meter.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,1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices a
12、nd is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Nov. 10, 2002. Published January 2003. Originallypublished in 1993. Last previous edition approved in 2002 as F 1472 02.2Annual Book of ASTM Standards, Vol 03.01.3Annual Book of ASTM Standards,
13、Vol 03.05.4Annual Book of ASTM Standards, Vol 01.01.5Annual Book of ASTM Standards, Vol 03.06.6Annual Book of ASTM Standards, Vol 13.01.7Available from American Society for Quality, 600 N. Plankinton Ave.,Milwaukee, WI 53203.8Available from SAE, 400 Commonwealth Dr., Warrendale, PA 15096-0001.9New d
14、esignation 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 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5.1.3 Form (sheet, strip, plate, bar, or wire),5.1.4 Cond
15、ition (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, or drawing number,5.1.8 Special tests, if any, and5.1.9 Other requirements.6. Materials and Manufacture6.1 The various titanium mil
16、l 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 electronbeam) of a type conventionally used f
17、or 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.6.3 ConditionMaterial shall be furnished in the a
18、nnealedor 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 from the finished mill product. Supplier shall
19、not 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 verify compliance with this
20、specification.7.2 Product AnalysisProduct analysis tolerances do notbroaden the specified heat analysis requirements but covervariations between laboratories in the measurement of chemi-cal content. The supplier shall not ship material that is outsidethe limits specified in Table 1. The product anal
21、ysis tolerancesshall conform to the product tolerances in Table 2.7.2.1 The product analysis is either for the purpose ofverifying the composition of a heat or manufacturing lot or todetermine variations in the composition within the heat.7.2.2 Acceptance or rejection of a heat or manufacturing loto
22、f material may be made by the purchaser on the basis of thisproduct analysis.7.2.3 For referee purposes, use Test Methods E 120, E 1409,and E 1447 or other analytical methods agreed upon betweenthe purchaser and the supplier.7.3 Ensure that the samples for chemical analysis arerepresentative of the
23、material being tested. The utmost caremust be used in sampling titanium for chemical analysisbecause of its affinity for elements such as oxygen, nitrogen,and hydrogen. In cutting samples for analysis, therefore, theoperation should be carried out insofar as possible in adust-free atmosphere. Cuttin
24、g tools should be clean and sharp.Samples for analysis should be stored in suitable containers.8. Mechanical Requirements8.1 The material supplied under this specification shallconform to the mechanical property requirements in Table 3.8.2 Specimens for tension tests shall be machined and testedin a
25、ccordance with Test Methods E 8. 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 increased so as to produce fracture in approximately oneadditional minute.8.3 For sheet and strip, the bend test specim
26、en 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 that has a diameter equal to that shownin Table 3. Test conditions shall conform to Test Method E 290.8.4 Number of Tests:8.4.1 Bar, Forging
27、Bar, Shapes, and WirePerform at leastone tension test from each lot. Should any of these testspecimens not meet the specified requirements, test two addi-tional test pieces representative of the same lot, in the samemanner, for each failed test specimen. The lot will be consid-ered in compliance onl
28、y if both additional test pieces meet thespecified requirements.8.4.2 Sheet, Strip, and PlatePerform at least one tensionand one bend test from each lot. Tension and bend propertyrequirements apply in both the longitudinal and transversedirections. Tests in the transverse direction need be made only
29、on product from which a specimen not less than 8.0 in. (200mm) in length for sheet and 2.50 in. (64 mm) in length for platecan be taken. Should any of these test specimens not meet theTABLE 1 Chemical RequirementsAElement Composition, %Nitrogen, max 0.05Carbon, max 0.08Hydrogen, maxB0.015Iron, max 0
30、.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 bedetermined or certified.TABLE 2 Product Analysis ToleranceAElementTol
31、erance 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 only a minimumpercentage is indicated.F 1472 02a2specified requireme
32、nts, test two additional test pieces represen-tative of the same lot, in the same manner, for each failed testspecimen. The lot will be considered in compliance only ifboth additional test pieces meet the specified requirements.9. Special Requirements9.1 The microstructure shall be a fine dispersion
33、 of the 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
34、the material 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. Certification10.1 The su
35、pplier shall provide a certification that thematerial was tested in accordance with this specification. Areport of the test results shall be furnished to the purchaser atthe time of shipment.11. Quality Program Requirements11.1 The producer shall maintain a quality program asdefined in ASQ C1.12. Ke
36、ywords12.1 metals (for surgical implants); orthopaedic medicaldevices; titanium alloys; titanium alloys (for surgical implants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thechemical, physical, mechanical, and metallurgical properties of
37、wrought 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 biological response since1983. (1, 2).10X1.3 This
38、alloy exhibits similar mechanical properties toSpecification F 136 required for the application of load-bearingorthopedic implants (2-18).X1.4 This titanium base alloy, UNS R56400, has been usedextensively in the aerospace industry since the 1950s. Aero-space Material Specification AMS 4928 includes
39、 the chemicaland mechanical properties for Titanium Alloy Bars, Wire,Forgings, Rings, and Drawn Shapes 6Al-4V Annealed. Aero-space Material Specification AMS 4911 includes the chemicaland mechanical properties for Titanium Alloy Sheet, Strip, andPlate 6Al-4V Annealed. ISO standard 5832-3, Implants f
40、or10The boldface numbers refer to references listed at the end of this standard.TABLE 3 Annealed Mechanical PropertiesASize, Nominal Diameter or DistanceBetween Parallel Sides,in. (mm)Tensile Strength,Bpsi, (MPa), minYield Strength,Bat 0.2 % Offset,psi (MPa), minElongationCin 2 in. (50 mm),or 4D or
41、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) 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, S
42、trip, 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), 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 . . . . .
43、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 factorG= 10TAMechanical properties for conditions other than those listed in this table may be established by agreement bet
44、ween 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 greater in diameter or thickness shall be measured using a gage length of 2 in. or 4D or 4T. Elongation of material un
45、der0.062 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.ETransverse requirements in Table 3 apply only to product from which a tensile specimen not less than 2.50 in. (63.5 mm) in le
46、ngth 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.)F 1472 02a3surgeryMeta
47、llic materialsPart 3: Wrought titanium6-aluminium4-vanadium alloy also describes titanium basealloy UNS R56400.X1.5 This alloy can be solution treated and aged to achievedifferent properties according to, for example, AMS 4965Titanium Alloy, Bars, Wire, Forgings, and Rings 6.0Al-4.0VSolution Heat Tr
48、eated and Aged.X2. BIOCOMPATIBILITYX2.1 The material composition covered by this specifica-tion has been used successfully in contact with soft tissue andbone since 1983 (12).X2.2 No known surgical implant material has ever beenshown to be completely free from adverse reactions in thehuman body. Lon
49、g-term clinical experience of the use of thematerial referred to in this specification, however, has shownthat an acceptable level of biological response can be expected,if the material is used in appropriate applications.X2.3 The material in this specification has been subjectedto animal studies and has been shown to produce a well-characterized level of biological response that is equal to orless than that produced by the reference material titanium. Thismaterial has been used clinically since 1983 (1, 2, 19).REFERENCES(1) Dobbs, H. S., and Scales, J. T., “Behavio
