1、Designation: F 2146 07Standard Specification forWrought Titanium-3Aluminum-2.5Vanadium Alloy SeamlessTubing for Surgical Implant Applications (UNS R56320)1This standard is issued under the fixed designation F 2146; the number immediately following the designation indicates the year oforiginal adopti
2、on or, in the case 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 req
3、uirements for wrought and annealed or cold-worked and stress-relieved titanium-3aluminum-2.5vanadiumalloy (UNS R56320) seamless tubing to be used in themanufacture of surgical implants. See Section 4 for sizelimitations.1.2 The values stated in inch pound units are to be regardedas the standard. The
4、 SI equivalents in parentheses are forinformation only.1.3 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility
5、 of regulatory requirements prior to use.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 1409 Test Method for Determination of Oxygen andNitrogen in
6、 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 Conductivity/Infrared Detection MethodE 2371 Test Method for Analysis of Titanium and TitaniumAlloys by Atomic Emission Plasma
7、SpectrometryF 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)2.2 Aerospace Material Specificati
8、ons:3AMS 2244 Tolerances, Titanium and Titanium Alloy Tub-ingAMS 2249 Chemical Check Analysis Limits, Titanium andTitanium AlloysAMS 2634 Ultrasonic Inspection, Thin Wall Metal TubingAMS 4943 Titanium Alloy, Seamless, Hydraulic Tubing,3.0A1-2.5V AnnealedAMS 4944 Titanium Alloy, Seamless, Hydraulic T
9、ubing,3.0A1-2.5V Cold-Worked, Stress-RelievedAMS 6940 Titanium Alloy Bars, Forgings, and ForgingStock, 3.0Al-2.5V Annealed-UNS R563202.3 American Society for Quality Standard:4ASQ C1 Specifications of General Requirements for aQuality Program2.4 ISO Standards:5ISO 6892 Metallic Materials Tensile Tes
10、ting at AmbientTemperatureISO 9001 Quality Management Systems Requirements3. Terminology3.1 Definitions of Terms Specific to This Standard:3.2 beta transus, nthe minimum temperature at which thealpha plus beta phase can transform to 100 % beta phase onheating.3.3 cold work, nany mechanical deformati
11、on processperformed below the recrystallization temperature which re-sults in strain hardening of the material.3.4 lot, ntotal number of tubes produced from the sameheat under the same conditions at essentially the same time.4. Product Classification4.1 TubingTubular product with an outside diameter
12、greater than 0.250 in. (6.35 mm).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 approved Feb. 1, 2007. Published February 2007. Original
13、lyapproved in 2001. Last previous edition approved in 2001 as F 2146 01.2For 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 AS
14、TM website.3Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.5Available from American National Standards Institute
15、(ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.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.5. Ordering Information5.1 Include with inquir
16、ies and orders for material under thisspecification the following information:5.1.1 Quantity,5.1.2 ASTM designation and date of issue (for example,F 2146 07),5.1.3 Form (seamless tubing),5.1.4 Applicable dimensions including outside diameter,wall thickness, length (exact, random, or multiples), or d
17、rawingnumber,5.1.5 Finish (see 6.1),5.1.6 Condition (see 6.2),5.1.7 Mechanical properties (if applicable, for special con-ditions),5.1.8 Special tests (see Section 9), and5.1.9 Other requirements.6. Materials and Manufacture6.1 FinishThe mill product shall be furnished to theimplant manufacturer as
18、descaled or pickled, abrasive blasted,chemically milled, ground, machined, peeled, polished, or asspecified by the purchaser.6.2 Condition:6.2.1 AnnealedTubing may be annealed by heating to atemperature within the range of 1100 to 1450F (593 to788C), holding at the selected temperature within 625F(6
19、14C) for not less than 15 min, and cooling at a rateequivalent to air cool or slower.6.2.2 Cold-Worked and Stress-RelievedTubing may becold-worked then stress-relieved by heating within the range700 to 1000F (371 to 538C) for not less than 30 min.6.3 Surface CleanlinessThe inside and outside surface
20、s ofthe tubing shall be free from grease and other foreign matter.Metallic flakes or particles shall not be collected by a clean,white cloth drawn through the bore of a tube sample. Discol-oration of the cloth, without the presence of metallic flakes orparticles, is acceptable.6.4 Dimensional Tolera
21、ncesAll tolerances shall conformto all applicable requirements of AMS 2244, for standardtolerances.7. Chemical Composition7.1 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
22、-gen shall be taken from each lot of finished mill product. Thenumber of samples per lot shall be as agreed upon between thesupplier and the purchaser. The supplier shall not ship materialwith a composition outside the requirements specified in Table1.7.1.1 Requirements for major and minor elemental
23、 constitu-ents are listed in Table 1. Also listed are important residualelements. Analysis for elements not listed in Table 1 is notrequired 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 bu
24、t cover variations betweenlaboratories in the measurement of chemical content. Theproduct analysis tolerances shall conform to the 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 todetermine variations in
25、 the composition 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 analyses outside the tolerance limitsallowed in Table 2 are cause for rejection of the product. Areferee analysis may be
26、 used if agreed upon by supplier andpurchaser.7.2.4 For referee purposes, use Test Methods E1409,E 1447, and E 2371 or other 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 mus
27、t 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. Samples
28、 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 3.8.2 Specimens for tension tests shall be machined and testedin accordance with Test Methods E8. Tensile pr
29、operties 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.TABLE 1 Chemical RequirementsElementComposition, % (mass/mass)Minimum MaximumNitrogen .
30、. . 0.020Carbon . . . 0.050Hydrogen . . . 0.015Iron . . . 0.30Oxygen . . . 0.12Aluminum 2.50 3.50Vanadium 2.00 3.00Yttrium . . . 0.005TitaniumAbalance balanceAThe percentage of titanium is determined by difference and need not bedetermined directly or certified.TABLE 2 Product Analysis TolerancesAEl
31、ementTolerance Under the Minimumor Over the Maximum LimitBNitrogen 0.02Carbon 0.02Hydrogen 0.0020Iron 0.10Oxygen (up to 0.20) 0.02Aluminum 0.40Vanadium 0.15Yttrium 0.0006ARefer to AMS 2249.BUnder the minimum limit not applicable for elements where only a maximumlimit is indicated.F21460728.3 Tensile
32、 tests results for which any specimen fracturesoutside the gauge 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 Method E8. If either the elongation or reduction of area isless than
33、the minimum requirement, discard the test and retest.Retest one specimen for each specimen that did not meet theminimum requirements.8.4 Number of TestsShould any test result not meet thespecified requirements, two additional samples representativeof the same lot shall be tested in the same manner,
34、for eachfailed test piece. The lot will be considered in compliance onlyif all additional test pieces meet the specified requirements.9. Special Requirements9.1 The microstructure shall be a fine dispersion of the alphaand beta phases resulting from processing in the alpha plus betafield. There shal
35、l be no continuous alpha network at prior betagrain boundaries. There shall be no coarse, elongated alphaplatelets.9.2 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 casewhe
36、n examined at 1003 magnification.9.3 Number of TestsExamine two samples from each loton a transverse plane for alpha and beta phases and for alphacase.9.4 If required by the purchaser, determine the beta transustemperature for each heat by a suitable method and report onthe material certification.9.
37、5 Ultrasonic Testing:9.5.1 Each tube shall be inspected ultrasonically in accor-dance with AMS 2634 for surface (inside diameter and outsidediameter) and subsurface imperfections of all types and orien-tation (longitudinal and transverse).9.6 Longitudinal and transverse notches not exceeding0.010 in
38、. (0.25 mm) in width and 10 % of the nominal tubewall or 0.004 in. (0.102 mm), whichever is greater, in depthshall be machined on the inner and outer surfaces of the tube.The length of the notches shall not exceed 0.125 in. (3.18 mm).9.7 Any tube showing an indication in excess of thatobtained from
39、the calibration standard in accordance with 9.6shall be set aside and be subject to rework, retest, or rejection.Atube thus set aside may be examined further for confirmationof the presence of a defect and may be resubmitted forinspection if no defect is found. Any tube may also beresubmitted for in
40、spection if reworked so as to remove thedefect within the specified diameter and wall thickness toler-ances.10. Significance of Numerical Limits10.1 The following applies to all specified numerical limitsin this specification. To determine conformance to these limits,an observed or calculated value
41、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. Certification11.1 The supplier shall provide a certification that thematerial was tested in accordance with this specification andmet
42、all requirements. A report of the test results shall befurnished to the purchaser at the time of shipment.12. Quality Program Requirements12.1 The producer shall maintain a quality program asdefined in ASQ C1 or ISO 9001.13. Keywords13.1 metals (for surgical implants); orthopaedic medicaldevices; ti
43、tanium alloys; titanium/titanium alloys (for surgicalimplants); tube; tubingTABLE 3 Mechanical PropertiesACondition Ultimate TensileStrength, min,psi (MPa)Yield Strength(0.2 %), min,psi (MPa)Elongation,Bmin, %Annealed 90 000 (621) 75 000 (517) 15Cold-worked andstress-relieved125 000 (862) 105 000 (7
44、24) 10CAMechanical properties for conditions other than those listed in this table maybe established by agreement between the supplier and purchaser.BElongation is based on a 2 in. (50.8 mm) or 4D gauge length for tubing38 in.(9.5 mm) outside diameter or larger, and 1.00 in. (25.4 mm) or 4D gauge le
45、ngth fortubing less than38 in. (9.5 mm) outside diameter and greater than14 in. (6.35mm) outside diameter.CElongation is 8 % minimum for tubing with wall thicknesses up to 0.016 in.(0.41 mm), inclusive.F2146073APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is
46、 to characterize thechemical, mechanical, and metallurgical properties of wroughtannealed or cold-worked and stress-relieved titanium-3aluminum-2.5vanadium alloy (UNS R56320) seamless tubingto be used in the manufacture of surgical implants.X1.2 The microstructural requirements contained in thisspec
47、ification represent the current general consensus withrespect to optimization of mechanical properties for implantapplications.X1.3 The minimum mechanical properties specified ensurea baseline of strength and ductility for the highly stresseddevices for which this alloy is typically used.X1.4 This a
48、lloy is similar in microstructure to bothtitanium-6aluminum-4vanadium ELI (Specification F 136) andtitanium-6aluminum-4vanadium (Specification F 1472), but isnot as highly alloyed as either of these two titanium alloys.X1.5 This alloy has also been characterized for aerospaceand industrial applicati
49、ons, and exhibits similar mechanicalproperties to titanium alloys used in load-bearing orthopedicimplant applications. Published standards include: AMS 4943,AMS 4944, and AMS 6940.X1.6 This alloy has also been used commercially inmedical and surgical devices for over a decade.6X1.7 ISO standards are listed for reference only. AlthoughISO 6892 listed in 2.4 is similar to the corresponding ASTMstandard, it is not identical. Use of the ISO standard instead ofthe preferred ASTM standard (Test Methods E8) may beagreed upon between the purchaser and supplier.X1.8 T
