ASTM F136-2013 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)《外科植入物用锻制钛-6铝-4钒ELI .pdf

1、Designation: F136 12aF136 13Standard 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

2、originaladoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the chemical, mechanical, and metallu

3、rgical 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 regarded as standard. The values given in parentheses are mathematicalconversions t

4、o SI units that are provided for information only and are not considered standard.2. Referenced Documents2.1 ASTM Standards:2E8/E8M Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsE290 Test Metho

5、ds for Bend Testing of Material for DuctilityE539 Test Method for Analysis of Titanium Alloys by X-Ray Fluorescence SpectrometryE1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas FusionE1447 Test Method for Determination of Hydrogen in Titanium an

6、d Titanium Alloys by Inert Gas Fusion ThermalConductivity/Infrared Detection MethodE1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion AnalysisE2371 Test Method for Analysis of Titanium and Titanium Alloys by Direct Current Plasma and Induct

7、ively Coupled PlasmaAtomic Emission Spectrometry (Performance-Based Test Methodology)F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials onMuscle and Bone2.2 ISO Standards:3ISO 6892 Metallic Materials Tensile Testing at Ambient Temp

8、eratureISO 9001 Quality Management Systems Requirements2.3 ASQ Standard:ASQ C1 Specifications of General Requirements for a Quality Control Program42.4 Aerospace Material Specifications:5AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium AlloysAMS 2631 Ultrasonic InspectionTitanium and T

9、itanium Alloy Bar and BilletAMS 2380 Approval and Control of Premium Quality Titanium Alloys3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 beta transus, nthe minimum temperature at which the alpha plus beta phase can transform to 100 % beta phase.1 This specification is under

10、 the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Dec. 1, 2012Nov. 1, 2013. Published December 2012December 2013. Originally published in 1984. Last previous

11、 edition approved in 2012 asF136 12.F136 12a. DOI: 10.1520/F0136-12A.10.1520/F0136-13.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary

12、page on the ASTM website.3 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.4 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.org.5 Available from Society of Au

13、tomotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http:/www.sae.org.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possi

14、ble to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the end of this standardCopy

15、right ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.2 lot, nthe total number of mill products produced from one heat under the same conditions at essentially the same time.4. Product Classification4.1 StripAny product under 0.1875 in. (4.

16、76 mm) in thickness and under 24 in. (610 mm) wide.4.2 SheetAny product under 0.1875 in. (4.76 mm) in thickness and 24 in. (610 mm) or more in width.4.3 PlateAny product 0.1875 in. (4.76 mm) thick and over and 10 in. (254 mm) wide and over, with widths greater than fivetimes thickness. Plate up to 4

17、.00 in. (101.60 mm), thick inclusive is covered by this specification.4.4 BarRound bars and flats from 0.1875 in. (4.76 mm) to 4.00 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 production of forgings, may be furnis

18、hed in the hot worked condition.4.6 WireRounds, flats, or other shapes less than 0.1875 in. (4.76 mm) in diameter.4.7 OtherOther forms and shapes, including tubing, may be provided by agreement between purchaser and supplier.5. Ordering Information5.1 Include with inquiries and orders for material u

19、nder this specification 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 and 6.3),5.1.5 Mechanical properties (if applicable, for special conditions),5.1.6 Finish (See 6.2),5.1

20、.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 mill products covered in this specification normally are formed with the conventional forging androlling

21、equipment found in primary ferrous and nonferrous plants. The alloy is usually multiple melted in arc furnaces (includingfurnaces such as plasma arc and electron beam) of a type conventionally used for reactive metals.6.2 FinishThe mill product may be furnished to the implant manufacturer as mechani

22、cally descaled or pickled, abrasivelyblasted, chemically milled, ground, machined, peeled, polished, combinations of these operations, or as specified by the purchaser.On billets, bars, plates, and forgings, it is permissible to remove minor surface imperfections by grinding if the resultant area me

23、etsthe dimensional and surface finish requirements of this specification.6.3 ConditionMaterial shall be furnished in the annealed or cold-worked condition. Mechanical properties for conditions otherthan those listed in Table 1 and Table 2 may be established by agreement between the supplier and the

24、purchaser.7. Chemical Requirements7.1 The heat analysis shall conform to the chemical composition specified in Table 3. Ingot analysis may be used for reportingall chemical requirements, except hydrogen. Samples for hydrogen shall be taken from the finished mill product. The supplier shallnot ship m

25、aterial with chemistry outside the requirements specified in Table 3.TABLE 1 Annealed 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)ElongationA in 4D or 4W min, % Red

26、uction of AreaB min, %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), incl 120 000 (825) 110 000 (760) 8 . . 20 . .2.50 (63.50) to 4.00 (101.

27、60), incl 120 000 (825) 110 000 (760) 8 8C 8C 15 15C 15CA Elongation 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 reported with the test results. The method for determining elongation of ma

28、terial 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, where So is the originalcross sectional area.) Gage length shall be report

29、ed with the elongation value. L = longitudinal; LT = long transverse; ST = short transverse.B Applies 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.C

30、Transverse 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 1327.1.1 Requirements for the major and minor elemental constituents are listed in Table 3. Also listed are important residualelements. Analysis for

31、elements not listed in Table 3 is not required to verify compliance with this specification.7.2 Product Analysis:7.2.1 Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations betweenlaboratories in the measurement of chemical content. The product anal

32、ysis tolerances shall conform to the product tolerances inTable 4.7.2.2 The product analysis is either for the purpose of verifying the composition of a heat or manufacturing lot or determiningvariations in the composition within the heat.TABLE 2 Annealed Mechanical Properties of Sheet, Strip, and P

33、lateNominal Diameteror Distance BetweenParallel Sides, in. (mm)Tensile Strengthmin,psi (MPa)Yield Strength(0.2 % offset) min,psi (MPa)ElongationA in 2 in. (50 mm),min, % Reduction of AreaB min, %Bend TestMandrel DiameterC,DLLTSTLLTSTUnder0.070 in.(1.78 mm)inThickness0.070 to0.1875 in.(1.78 to4.75 mm

34、)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 (63.50), incl120 000 (825) 110 000 (760) 8 . . 20 . . . .2.50 (63.50) to4.00 (101.60), incl1

35、20 000 (825) 110 000 (760) 8 8E 8E 15 15E 15E . .A Elongation 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 testresults. The method for determining elongation of material less than 0.063 in. (1.6 m

36、m) in thickness may be negotiated. Alternatively, a gage length corresponding to ISO6892 may be used when agreed upon between supplier and purchaser. (5.65 times the square root of So, where So is the original cross sectional area.) Gage length shallbe reported with the elongation value. L = longitu

37、dinal; LT = long transverse; ST = short transverse.B Applies to plate only. L = longitudinal; LT = long transverse; ST = short transverse.C The bend test is applicable to sheet and strip products.D T equals the thickness of the bend test specimen. Refer to Test Methods E290. Bend tests are not appli

38、cable to material over 0.187 in. (4.75 mm) in thickness.E Transverse 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 Chemical RequirementsElement Composition, %(mass/mass)Nitrogen, max 0.05Carbon, max 0.08

39、Hydrogen, max 0.012AIron, max 0.25Oxygen, max 0.13Aluminum 5.56.50Vanadium 3.54.5TitaniumB balanceA Material 0.032 in. (0.813 mm) and under may have hydrogen content up to0.0150 %.B The percentage of titanium is determined by difference and need not bedetermined or certified.TABLE 4 Product Analysis

40、 ToleranceAElementTolerance Under the Minimum orOver the Maximum LimitB% (mass/mass)Nitrogen 0.02Carbon 0.02Hydrogen 0.0020Iron 0.10Oxygen 0.02Aluminum 0.40Vanadium 0.15A See AMS 2249.B Under minimum limit not applicable for elements where only a minimumpercentage is indicated.F136 1337.2.3 Acceptan

41、ce or rejection of a heat or manufacturing lot of material may be made by the purchaser on the basis of thisproduct analysis. Product analysis outside the tolerance limits allowed in Table 4 is cause for rejection of the product. A refereeanalysis may be used if agreed upon by the supplier and purch

42、aser.7.2.4 For referee purposes, use Test Methods E539, E1409, E1447, E1941, and E2371 or other analytical methods agreed uponbetween the purchaser and the supplier.7.3 Samples for chemical analysis shall be representative of the material being tested. The utmost care must be used in samplingtitaniu

43、m for chemical analysis because of its affinity for elements such as oxygen, nitrogen, and hydrogen. In cutting samples foranalysis, therefore, the operation should be carried out insofar as possible in a dust-free atmosphere. Cutting tools should be cleanand sharp. Samples for analysis should be st

44、ored in suitable containers.8. Mechanical Requirements8.1 The material supplied under this specification shall conform to the mechanical property requirements in Table 1 and Table2.8.2 Specimens for tension tests shall be prepared and tested in accordance with Test Methods E8/E8M. Tensile properties

45、 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 may beincreased so as to produce fracture in approximately one additional minute.8.2.1 Bar, Forging Bar, Shapes, and WireTest according to Test Methods E8/E8M. Should any test

46、 specimen not meet thespecified requirements, test two additional test pieces representative of the same lot, in the same manner, for each failed testspecimen. The lot will be considered in compliance only if all additional test pieces meet the specified requirements.8.2.2 Tensile tests results for

47、which any specimen fractures outside the gage length shall be considered acceptable, if both theelongation and reduction of area meet the minimum requirements specified. Refer to subsections 7.11.4 and 7.12.5 of Test MethodsE8/E8M. If either the elongation or reduction of area is less than the minim

48、um requirement, discard the test and retest. Retest onespecimen for each specimen that did not meet the minimum requirements.8.3 For sheet and strip, the bend test specimen shall withstand being bent cold through an angle of 105 without fracture in theoutside surface of the bent portion. The bend sh

49、all be made around a mandrel which has a diameter equal to that shown in Table2. Test conditions shall conform to Test Method E290.8.3.1 Sheet, Strip, and PlateTest according to Test Methods E8/E8M. Perform at least one tensile test from each lot in boththe longitudinal and transverse directions. Tests in the transverse direction need be made only on product from which a specimennot less than 8.0 in. (200 mm) in length for sheet and 2.50 in. (64 mm) in length for plate can be taken. Should any of these testspecimens not meet the specified requir