Designation: F 2146 01

Standard 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 adoption 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. Scope1.1 This specification covers the chemical, mechanical, and

metallurgical requirements for wrought 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 3 for sizelimitation.

1.2 The values stated in inch pound units are to be regardedas the standard. The 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 of regulatory requirements prior to use.2. Referenced Documents

2.1 ASTM Standards:E 8 Test Methods for Tension Testing of Metallic Materials2E 120 Test Methods for Chemical Analysis of Titanium and

Titanium Alloys3E 1409 Test Method for Determination of Oxygen in Tita-

nium and Titanium Alloys by the Inert Gas Fusion Tech-nique4

E 1447 Test Method for Determination of Hydrogen inTitanium and Titanium Alloys by the Inert Gas FusionThermal Conductivity Method4

F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNSR56401) for Surgical Implant Applications5

F 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy (UNS R56400) for Surgical ImplantApplications5

2.2 Aerospace Material Specifications:

AMS 2244 Tolerances, Titanium and Titanium Alloy Tub-ing6

AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium Alloys6

AMS 2634 Ultrasonic Inspection, Thin Wall Metal Tubing6AMS 4943 Titanium Alloy, Seamless, Hydraulic Tubing,

3.0A1-2.5V Annealed6AMS 4944 Titanium Alloy, Seamless, Hydraulic Tubing,

3.0A1-2.5V Cold-Worked, Stress-Relieved62.3 ANSI Publication:ANSI/ASME B46.1 Surface Texture, Surface Roughness

Waviness and Lay72.4 American Society for Quality Standard:ASQ C1 Specifications of General Requirements for a

Quality Program82.5 Military Standard:MIL-T-9047 Titanium and Titanium Alloy Bars (Rolled or

Forged) and Reforging Stock, Aircraft Quality9

3. Classification3.1 TubingRound product with an outside diameter

greater than 0.250 in. (6.35 mm).4. Ordering Information

4.1 Include with inquiries and orders for material under thisspecification the following information:

4.1.1 Quantity,4.1.2 ASTM designation and date of issue,4.1.3 Form (seamless tubing),4.1.4 Condition (see 5.1),4.1.5 Mechanical properties (if applicable, for special con-

ditions),4.1.6 Finish (see 5.2),4.1.7 Applicable dimensions including outside diameter,

wall thickness, length (exact, random, or multiples), or drawingnumber,

1 This 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 Oct. 10, 2001. Published January 2002.2 Annual Book of ASTM Standards, Vol 03.01.3 Annual Book of ASTM Standards, Vol 03.05.4 Annual Book of ASTM Standards, Vol 03.06.5 Annual Book of ASTM Standards, Vol 13.01.

6 Available from Society of Automotive Engineers, Inc., 400 Commonwealth Dr.,Warrendale, PA 15096-0001.

7 Available from American National Standards Institute, 25 W. 43rd St., 4thFloor, New York, NY, 10036.

8 Available from American Society for Quality, 600 N. Plankinton Ave.,Milwaukee, WI 53203.

9 Available from Standardization Documents Order Desk, Bldg. 4, Section D,700 Robbins Ave., Philadelphia, PA 191115098, Attn: NPODS.

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Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.

4.1.8 Special tests (see 8.1-8.3), and4.1.9 Other requirements.

5. Materials and Manufacture5.1 Condition:5.1.1 AnnealedTubing may be annealed by heating to a

temperature within the range 1100 to 1450F (593 to 788C),holding at the selected temperature within 625F (614C) fornot less than 15 min, and cooling at a rate equivalent to air coolor slower.

5.1.2 Cold-Worked and Stress-RelievedTubing may becold-worked and stress-relieved by heating within the range700 to 1000F (371 to 538C) for not less than 30 min.

5.2 FinishMaterial surfaces will be furnished in accor-dance with the customer order, which may include pickling,polishing, or grit blasting, or a combination of these operations.

5.3 Surface CleanlinessThe inside diameter and outsidediameter surfaces of the tubing shall be free from grease andother foreign matter. Metallic flakes or particles shall not becollected by a clean, white cloth drawn through the bore of atube sample. Discoloration of the cloth, without the presence ofmetallic flakes or particles, is acceptable.

5.4 Dimensional TolerancesAll tolerances shall conformto all applicable requirements of AMS 2244, for standardtolerances.

6. Chemical Composition6.1 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 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 materialoutside the requirements specified in Table 1.

6.1.1 Requirements for major and minor elemental 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.

6.2 Product AnalysisProduct analysis tolerances do notbroaden the specified heat analysis requirements but covervariations between laboratories in the measurement of chemi-cal content. The manufacturer shall not ship material that isoutside the limits specified in Table 1. The product analysistolerances shall conform to the product tolerances in Table 2.

6.2.1 The product analysis is either for the purpose ofverifying the composition of a heat or manufacturing lot or to

determine variations in the composition within the heat.6.2.2 Acceptance or rejection of a heat or manufacturing lot

of material may be made by the purchaser on the basis of thisproduct analysis.

6.3 For referee purposes, use Test Methods E 120, E 1409,and E 1447 or other analytical methods agreed upon betweenthe purchaser and the supplier.

6.4 Ensure that the samples for chemical analysis arerepresentative of the 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. Cutting tools should be clean and sharp.Samples for analysis should be stored in suitable containers.

7. Mechanical Properties7.1 The material supplied under this specification shall

conform to the mechanical property requirements in Table 3.7.2 Specimens for tension tests shall be machined and tested

in accordance 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.

7.3 Number of TestsPerform a minimum of two tensiontests from each lot. A lot is defined as the total number of millproducts produced under the same conditions at essentially thesame time from the same heat. If both test specimens fail, thelot is unacceptable. Should either of the two test specimens notmeet the specified requirements, test two additional test piecesrepresentative of the same lot in the same manner. The lot will

TABLE 1 Chemical Requirements

ElementComposition, % (mass/mass)

Minimum Maximum

Nitrogen . . . 0.020Carbon . . . 0.050Hydrogen . . . 0.015Iron . . . 0.30Oxygen . . . 0.12Aluminum 2.50 3.50Vanadium 2.00 3.00Yttrium . . . 0.005TitaniumA balance balance

A The percentage of titanium is determined by difference and need not bedetermined or certified.

TABLE 2 Product Analysis ToleranceA

Element

Tolerance Under the Minimumor Over the Maximum Limit

as Listed in Table 1(Composition, % mass/mass)B

Nitrogen 0.02Carbon 0.02Hydrogen 0.0020Iron 0.10Oxygen (up to 0.20) 0.02Aluminum 0.40Vanadium 0.15Yttrium 0.0006

A Refer to AMS 2249.B Under the minimum limit not applicable for elements where only a maximum

limit is indicated.

TABLE 3 Mechanical PropertiesCondition Ultimate Tensile

Strength, min,psi (MPa)

Yield Strength(0.2 %), min,psi (MPa)

Elongation,A,Bmin, %

Annealed 90 000 (621) 75 000 (517) 15Cold-worked and

stress-relieved125 000 (862) 105 000 (724) 10B

A Elongation is based on a 2 in. (50.8 mm) or 4D gage length for tubing 38 in.(9.5 mm) outside diameter or larger, and 1.00 in. (25.4 mm) or 4D gage length fortubing less than 38 in. (9.5 mm) outside diameter and greater than 14 in. (6.35 mm)outside diameter.

B Elongation is 8 % minimum for tubing with wall thicknesses up to 0.016 in.(0.41 mm), inclusive.

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be considered in compliance only if both additional test piecesmeet the specified requirements. If a specimen fails outside thegage, the test is null in accordance with Test Methods E 8, anda retest shall be performed.

8. Special Tests8.1 Each tube shall be ultrasonically inspected in accor-

dance with AMS 2634 for surface (inside diameter and outsidediameter) and subsurface imperfections of all types and orien-tation (longitudinal and transverse).

8.2 Longitudinal and transverse notches not exceeding0.010 in. (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).

8.3 Any tube showing an indication in excess of thatobtained from the calibration standard in accordance with 8.2shall be set aside and be subject to rework, retest, or rejection.A tube 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 inspection if reworked so as to remove thedefect within the specified diameter and wall thickness toler-ances.

9. Microstructure9.1 The microstructure shall be a fine dispersion of the alpha

and 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 The tubing shall be free of any oxygen-rich layer, suchas alpha case, determined by metallographic examination at2003 magnification, or by another method as agreed uponbetween the purchaser and the supplier.

10. Certification10.1 The supplier shall provide a certification that the

material 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 as

defined in ASQ C1.

12. Keywords12.1 metals (for surgical implants); orthopaedic medical

devices; titanium alloys; titanium/titanium alloy; titanium/titanium alloys (for surgical implants); tube; tubing

APPENDIXES

(Nonmandatory Information)

X1. RATIONALE

X1.1 The purpose of this specification is 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 thisspecification 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 alloy is similar in microstructure to bothtitanium-6aluminum-4vanadium ELI (Specification F 136) andtitanium-6aluminum-4vanadium (Specification F 1472), but is

not as highly alloyed as either of these two titanium alloys.

X1.5 This alloy has also been characterized for aerospaceand industrial applications, and exhibits similar mechanicalproperties to titanium alloys used in load-bearing orthopedicimplant applications. Published standards include: AMS 4943Titanium Alloy, Seamless, Hydraulic Tubing, 3.0Al-2.5V An-nealed, AMS 4944 Titanium Alloy, Seamless, Hydraulic Tub-ing, 3.0Al-2.5V Cold-Worked, Stress-Relieved, and MIL-T-9047 Titanium and Titanium Alloy Bars (Rolled or Forged) andReforging Stock, Aircraft Quality.

X1.6 This alloy has also been used commercially inmedical and surgical devices since 1983.10

10 FDA 510K Application Number K926232, submitted by Howmedica, Inc.,Rutherford, NJ.

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X2. BIOCOMPATIBILITY

X2.1 The alloy composition covered by this specificationhas been employed successfully in human implant applicationsin contact with soft tissue and bone, exhibiting a well-characterized level of biological response, for over a decade.

X2.2 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. Long-term clinical experience of the use of the materialreferred to in this specification, however, has shown that an

acceptable level of biological response can be expected, if thematerial 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 by the reference material titanium. This materialhas been used clinically since 1983.

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