ASTM F136-2011 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) 《外科植入设备(UNS R56401).pdf

1、Designation: F136 11Standard Specification forWrought Titanium-6Aluminum-4Vanadium ELI (Extra LowInterstitial) Alloy for Surgical Implant Applications (UNSR56401)1This standard is issued under the fixed designation F136; the number immediately following the designation indicates the year of original

2、adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the chemical, mechanical, andmetallurgica

3、l 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. The values given in parentheses are mathematicalconversions to SI un

4、its that are provided for information onlyand are not considered standard.2. Referenced Documents2.1 ASTM Standards:2E8/E8M Test Methods for Tension Testing of MetallicMaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE290 Test Methods for Ben

5、d Testing of Material for Duc-tilityE539 Test Method for Analysis of Titanium Alloys byX-Ray Fluorescence SpectrometryE1409 Test Method for Determination of Oxygen andNitrogen in Titanium and Titanium Alloys by the Inert GasFusion TechniqueE1447 Test Method for Determination of Hydrogen inTitanium a

6、nd 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 Emission Plasma Spectro

7、metryF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 ISO Standards:3ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management Systems Requirements2.3 ASQ Standard:ASQ C1 S

8、pecifications 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:3.1.1 beta transus, nthe minimum temperature at whichthe alph

9、a 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. (4.76 mm) inthickness and under 24 in. (610 mm) wide.4.2 SheetA

10、ny 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 greaterthan five times thickness. Plate up to 4.00 in. (101.60 mm),thick inclusive is covered by this specific

11、ation.4.4 BarRound 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.1This specification is under the

12、 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 Dec. 15, 2011. Published January 2012. Originallypublished in 1984. Last previous edition approved in 2008 as F1

13、36 081. DOI:10.1520/F0136-11.2For 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 Nationa

14、l Standards Institute (ANSI), 25 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

15、15096-0001, http:/www.sae.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.4.6 WireRounds, flats, or other shapes less than 0.1875 in.(4.76 mm) in diameter.4.7 Othe

16、rOther forms and shapes, including tubing, maybe provided by agreement between purchaser and supplier.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,

17、 strip, plate, bar, forging bar, or wire),5.1.4 Condition (See Section 3 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 O

18、ther 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. The alloy is usually multiple melted in arcfurnaces (including fur

19、naces such as plasma arc and electronbeam) of a type conventionally used 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 oper

20、ations, or asspecified by the purchaser. On billets, bars, plates, and forg-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 anneal

21、edor cold-worked condition. Mechanical properties for condi-tions other 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

22、 analysis may be used forreporting all chemical requirements, except hydrogen. 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 elementalconsti

23、tuents are listed in Table 3. Also listed are importantresidual elements. 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

24、variations betweenlaboratories in the measurement of chemical content. Theproduct 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 comp

25、osition 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 analysis outside the tolerance limitsallowed in Table 4 is cause for rejection of the product. Areferee analysis may be used if a

26、greed upon by the supplier andpurchaser.7.2.4 For referee purposes, use Test Methods E539, E1409,E1447, E1941, and E2371 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 car

27、e 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 possible in a dust-free atmosphere.Cutting tools should be clean and sharp. Sa

28、mples 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 1and Table 2.8.2 Specimens for tension tests shall be machined and testedin accordance with Test Method

29、s E8/E8M. Tensile propertiesshall be determined using a strain rate of 0.003 to 0.007in./in./min (mm/mm/min) through yield and then the crossheadTABLE 1 Annealed Mechanical Properties of Bar, Wire, and ForgingsNominal Diameter or DistanceBetween Parallel Sides, in. (mm)Tensile Strength min,psi (MPa)

30、Yield Strength(0.2 % offset) min,psi (MPa)ElongationAin 4D or 4W min, % Reduction of AreaBmin, %LLTSTLLTSTUnder 0.187 (4.75) thickness ordiameter125 000 (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

31、), 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 0.063 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 repor

32、ted 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. Alternatively,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, wher

33、e So is the originalcross sectional area.) Gage length shall be reported with the elongation value. L = longitudinal; LT = long transverse; ST = short transverse.BApplies to bar and forgings only. L = longitudinal; LT = long transverse; ST = short transverse. For round bar, the long and short transv

34、erse are identical tests, thereforeonly one transverse is required.CTransverse requirements in Table 1 apply only to product from which a tensile specimen not less that 2.50 in. (63.5 mm) in length can be obtained.F136 112speed may be increased so as to produce fracture in approxi-mately one additio

35、nal minute.8.2.1 Bar, Forging Bar, Shapes, and WireTest accordingto Test Methods E8/E8M. 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 complia

36、nceonly if all additional test pieces meet the specified require-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 a

37、nd 7.12.5of Test Methods E8/E8M. If either the elongation or 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

38、cold through an angle of 105 without fracturein the outside surface 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 MethodE290.8.3.1 Sheet, Strip, and PlateTest according to Test Meth-ods E8/E8M. Pe

39、rform at least one tensile test from each lot inboth the longitudinal 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 th

40、ese test specimens not meet the specified require-ments, test two additional test pieces representative of the samelot, in the same manner, for each failed test specimen. The lotwill be considered in compliance only if all additional testpieces meet the specified requirements.9. Special Requirements

41、9.1 The microstructure shall 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

42、 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 case$0.001 in. whe

43、n examined at 1003 magnification.TABLE 2 Annealed Mechanical Properties of Sheet, Strip, and PlateNominal Diameteror Distance BetweenParallel Sides, in. (mm)Tensile Strengthmin,psi (MPa)Yield Strength(0.2 % offset) min,psi (MPa)ElongationAin 2 in. (50 mm),min, %Reduction of AreaBmin, %Bend TestMandr

44、el 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 under1.75 (44.45), incl125 000 (860) 115 000 (795) 10 . . 25 . . . .1.75 (44.45) to under2.50 (

45、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 measured using a gage length of 2 in. or 4 W. The gage length must be reported with the tes

46、tresults. 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 supplier and purchaser. (5.65 times the square root of So, where So is the original cros

47、s 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 transverse.CThe bend test is applicable to sheet and strip products.DT equals the thickn

48、ess of the bend test specimen. Refer to Test Methods E290. 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 tensile specimen not less that 2.50 in. (63.5 mm) in length can be obtained.TABLE 3 Chemic

49、al 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 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 0.10Oxygen 0.02Aluminum 0.40Vanadium 0.15ASee AMS 2