1、Designation: F 136 081Standard Specification forWrought Titanium-6Aluminum-4Vanadium ELI (Extra LowInterstitial) Alloy for Surgical Implant Applications (UNSR56401)1This standard is issued under the fixed designation F 136; the number immediately following the designation indicates the year oforigin
2、al adoption or, in the case 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.1NOTESubsection 8.3.1 was editorially corrected in December 2008.1. Scope*1.1
3、 This specification covers the chemical, mechanical, andmetallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy(R56401) to be used in the manufacture of surgical implants.1.2 The values stated in inch-pound units are to be regardedas standard.
4、The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.2. Referenced Documents2.1 ASTM Standards:2E 8/E 8M Test Methods for Tension Testing of MetallicMaterialsE29 Practice for Using Significant Digits in Test Dat
5、a toDetermine Conformance with SpecificationsE 290 Test Methods for Bend Testing of Material forDuctilityE 539 Test Method for X-Ray Fluorescence SpectrometricAnalysis of 6Al-4V Titanium AlloyE 1409 Test Method for Determination of Oxygen andNitrogen in Titanium and Titanium Alloys by the Inert GasF
6、usion TechniqueE 1447 Test Method for Determination of Hydrogen inTitanium and Titanium Alloys by the Inert Gas FusionThermal Conductivity/Infrared Detection MethodE 1941 Test Method for Determination of Carbon in Refrac-tory and Reactive Metals and Their AlloysE 2371 Test Method for Analysis of Tit
7、anium and TitaniumAlloys by Atomic Emission Plasma SpectrometryF 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 ISO Standards:3ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quali
8、ty Management Systems Requirements2.3 ASQ Standard:ASQ C1 Specifications of General Requirements for aQuality Control Program42.4 Aerospace Material Specifications:AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium Alloys53. Terminology3.1 Definitions of Terms Specific to This Standard:3.
9、1.1 beta transus, nthe 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 0.1875 in. (4.7
10、6 mm) inthickness and under 24 in. (610 mm) wide.4.2 SheetAny product under 0.1875 in. (4.76 mm) inthickness and 24 in. (610 mm) or more in width.4.3 PlateAny product 0.1875 in. (4.76 mm) thick andover and 10 in. (254 mm) wide and over, with widths greater1This specification is under the jurisdictio
11、n 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. 1, 2008. Published December 2008. Originallypublished in 1984. Last previous edition approved in 2002 as F 136 02a.2For
12、 referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25
13、W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.5Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.1*A
14、 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.than five times thickness. Plate up to 4.00 in. (101.60 mm),thick inclusive is covered by this specification.4.4 BarRound
15、bars and flats from 0.1875 in. (4.76 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 worked condition.4.6 WireRounds, flats, or other shapes less than 0.
16、1875 in.(4.76 mm) in diameter.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 (sheet, strip, plate, bar, forging bar, or wire),5.1.4 Condition (See Section 3
17、 and 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. Materials and Manufacture6.1 The various titanium m
18、ill 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
19、 for reactive metals.6.2 FinishThe mill product may be furnished to theimplant 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, and f
20、org-ings, it is permissible to remove minor surface imperfectionsby grinding if the resultant area meets the dimensional andsurface finish requirements of this specification.6.3 ConditionMaterial shall be furnished in the annealedor cold-worked condition. Mechanical properties for condi-tions other
21、than those listed in Table 1 and Table 2 may beestablished by agreement between the supplier and the pur-chaser.7. Chemical Requirements7.1 The heat analysis shall conform to the chemical com-position specified in Table 3. Ingot analysis may be used forreporting all chemical requirements, except hyd
22、rogen. Samplesfor hydrogen shall be taken from the finished mill product. Thesupplier shall not ship material with chemistry outside therequirements specified in Table 3.7.1.1 Requirements for the major and minor elementalconstituents are listed in Table 3. Also listed are importantresidual elements
23、. Analysis for elements not listed in Table 3 isnot 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 betweenlaboratories in the measurement of chemical content. T
24、heproduct analysis tolerances shall conform to the producttolerances in Table 4.7.2.2 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.7.2.3 Acceptance or rejection of a heat or manuf
25、acturing lotof material may be made by the purchaser on the basis of thisproduct analysis. Product analysis outside the tolerance limitsallowed in Table 4 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
26、Test Methods E 539, E 1409,E 1447, E 1941, and E 2371 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
27、 its affinityfor elements 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.TABLE 1 A
28、nnealed Mechanical Properties of Bar, Wire, and ForgingsNominal Diameter or DistanceBetween Parallel Sides, in. (mm)Tensile Strength min,psi (MPa)Yield Strength(0.2 % offset) min,psi (MPa)ElongationAin 4D or 4W min, % Reduction of AreaBmin, %LLTSTLLTSTUnder 0.187 (4.75) thickness ordiameter125 000 (
29、860) 115 000 (795) 10 . . . . .0.187 (4.75) to under 1.75 (44.45), incl 125 000 (860) 115 000 (795) 10 . . 25 . .1.75 (44.45) to under 2.50 (63.50), incl 120 000 (825) 110 000 (760) 8 . . 20 . .2.50 (63.50) to 4.00 (101.60), incl 120 000 (825) 110 000 (760) 8 8C8C15 15C15CAElongation of material 0.0
30、63 in. (1.6 mm) or greater in diameter (D) or width (W) shall be measured using a gage length of 2 in. or 4 D or 4 W. The gage length mustbe reported with the test results. The method for determining elongation of material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated. Alternat
31、ively,a gage length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser. (5.65 times the square root of So, where So is the originalcross sectional area.) Gage length shall be reported with the elongation value. L = longitudinal; LT = long transverse; ST = short tra
32、nsverse.BApplies to bar and forgings only. L = longitudinal; LT = long transverse; ST = short transverse. For round bar, the long and short transverse are identical tests, thereforeonly one transverse is required.CTransverse requirements in Table 1 apply only to product from which a tensile specimen
33、 not less that 2.50 in. (63.5 mm) in length can be obtained.F13608128. Mechanical Requirements8.1 The material supplied under this specification shallconform to the mechanical property requirements in Table 1and Table 2.8.2 Specimens for tension tests shall be machined and testedin accordance with T
34、est Methods E 8/E 8M. Tensile propertiesshall be determined using a strain rate of 0.003 to 0.007in./in./min (mm/mm/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 according
35、to Test Methods E 8/E 8M. Should any test specimen not meetthe specified requirements, test two additional test piecesrepresentative 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 requir
36、e-ments.8.2.2 Tensile 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 subsections 7.11.4 and 7.12.5of Test Methods E 8/E 8M. If either the elongation or
37、reductionof area is less than the minimum requirement, discard the testand retest. Retest one specimen for each specimen 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 s
38、urface of the bent portion. The bend shall bemade around a mandrel which has a diameter equal to thatshown in Table 2. Test conditions shall conform to Test MethodE 290.8.3.1 Sheet, Strip, and PlateTest according to Test Meth-ods E 8/E 8M. Perform at least one tensile test from each lot inboth the l
39、ongitudinal and transverse directions. Tests in thetransverse direction need be made only on product from whicha specimen not less than 8.0 in. (200 mm) in length for sheetand 2.50 in. (64 mm) in length for plate can be taken. Shouldany of these test specimens not meet the specified require-ments, t
40、est two additional test pieces representative of the samelot, in the same manner, for each failed test specimen. The lotTABLE 2 Annealed Mechanical Properties of Sheet, Strip, and PlateNominal Diameteror Distance BetweenParallel Sides, in. (mm)Tensile Strengthmin,psi (MPa)Yield Strength(0.2 % offset
41、) min,psi (MPa)ElongationAin 2 in. (50 mm),min, %Reduction of AreaBmin, %Bend TestMandrel DiameterC,DLLTSTLLTSTUnder0.070 in.(1.78 mm)inThickness0.070 to0.1875 in.(1.78 to4.75 mm)inThicknessUnder 0.187 (4.75)thickness or diameter125 000 (860) 115 000 (795) 10 . . . . . 9T 10T0.187 (4.75) to under1.7
42、5 (44.45), incl125 000 (860) 115 000 (795) 10 . . 25 . . . .1.75 (44.45) to under2.50 (63.50), incl120 000 (825) 110 000 (760) 8 . . 20 . . . .2.50 (63.50) to4.00 (101.60), incl120 000 (825) 110 000 (760) 8 8E8E15 15E15E. .AElongation of material 0.063 in. (1.6 mm) or greater width (W) shall be meas
43、ured using a gage length of 2 in. or 4 W. The gage length must be reported with the testresults. The method for determining elongation of material less than 0.063 in. (1.6 mm) in thickness may be negotiated. Alternatively, a gage length corresponding toISO 6892 may be used when agreed upon between s
44、upplier and purchaser. (5.65 times the square root of So, where So is the original cross sectional area.) Gage lengthshall be reported with the elongation value. L = longitudinal; LT = long transverse; ST = short transverse.BApplies to plate only. L = longitudinal; LT = long transverse; ST = short t
45、ransverse.CThe bend test is applicable to sheet and strip products.DT equals the thickness of the bend test specimen. Refer to Test Methods E 290. Bend tests are not applicable to material over 0.187 in. (4.75 mm) in thickness.ETransverse requirements in Table 2 apply only to product from which a te
46、nsile specimen not less that 2.50 in. (63.5 mm) in length can be obtained.TABLE 3 Chemical RequirementsElementComposition, %(mass/mass)Nitrogen, max 0.05Carbon, max 0.08Hydrogen, max 0.012AIron, max 0.25Oxygen, max 0.13Aluminum 5.56.50Vanadium 3.54.5TitaniumBbalanceAMaterial 0.032 in. (0.813 mm) and
47、 under may have hydrogen content up to0.0150 %.BThe percentage of titanium is determined by difference and need not bedetermined or certified.TABLE 4 Product Analysis ToleranceAElementTolerance Under the Minimum orOver the Maximum LimitB% (mass/mass)Nitrogen 0.02Carbon 0.02Hydrogen 0.0020Iron 0.10Ox
48、ygen 0.02Aluminum 0.40Vanadium 0.15ASee AMS 2249.BUnder minimum limit not applicable for elements where only a minimumpercentage is indicated.F1360813will be considered in compliance only if all additional testpieces meet the specified requirements.9. Special Requirements9.1 The microstructure shall
49、 be a fine dispersion 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 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 shall be no continuous layer of alpha
