ASTM F2146-01
(Specification)Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed or cold-worked and stress-relieved titanium-3aluminum-2.5vanadium alloy (UNS R56320) seamless tubing to be used in the manufacture of surgical implants. See Section 3 for size limitation.
1.2 The values stated in inch pound units are to be regarded as the standard. The SI equivalents in parentheses are for information only.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.
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Designation: F 2146 – 01
Standard Specification for
Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless
Tubing for Surgical Implant Applications (UNS R56320)
This standard is issued under the fixed designation F 2146; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 2.2 Aerospace Material Specifications:
AMS 2244 Tolerances, Titanium and Titanium Alloy Tub-
1.1 This specification covers the chemical, mechanical, and
ing
metallurgical requirements for wrought annealed or cold-
AMS 2249 Chemical Check Analysis Limits, Titanium and
worked and stress-relieved titanium-3aluminum-2.5vanadium
Titanium Alloys
alloy (UNS R56320) seamless tubing to be used in the
AMS 2634 Ultrasonic Inspection, Thin Wall Metal Tubing
manufacture of surgical implants. See Section 3 for size
AMS 4943 Titanium Alloy, Seamless, Hydraulic Tubing,
limitation.
3.0A1-2.5V Annealed
1.2 The values stated in inch pound units are to be regarded
AMS 4944 Titanium Alloy, Seamless, Hydraulic Tubing,
as the standard. The SI equivalents in parentheses are for
3.0A1-2.5V Cold-Worked, Stress-Relieved
information only.
2.3 ANSI Publication:
1.3 This standard does not purport to address all of the
ANSI/ASME B46.1 Surface Texture, Surface Roughness
safety concerns, if any, associated with its use. It is the
Waviness and Lay
responsibility of the user of this standard to establish appro-
2.4 American Society for Quality Standard:
priate safety and health practices and determine the applica-
ASQ C1 Specifications of General Requirements for a
bility of regulatory requirements prior to use.
Quality Program
2. Referenced Documents
2.5 Military Standard:
MIL-T-9047 Titanium and Titanium Alloy Bars (Rolled or
2.1 ASTM Standards:
Forged) and Reforging Stock, Aircraft Quality
E 8 TestMethodsforTensionTestingofMetallicMaterials
E 120 Test Methods for ChemicalAnalysis of Titanium and
3. Classification
Titanium Alloys
3.1 Tubing—Round product with an outside diameter
E 1409 Test Method for Determination of Oxygen in Tita-
greater than 0.250 in. (6.35 mm).
nium and Titanium Alloys by the Inert Gas Fusion Tech-
nique
4. Ordering Information
E 1447 Test Method for Determination of Hydrogen in
4.1 Include with inquiries and orders for material under this
Titanium and Titanium Alloys by the Inert Gas Fusion
4 specification the following information:
Thermal Conductivity Method
4.1.1 Quantity,
F 136 Specification for Wrought Titanium-6Aluminum-
4.1.2 ASTM designation and date of issue,
4Vanadium ELI (Extra Low Interstitial) Alloy (UNS
5 4.1.3 Form (seamless tubing),
R56401) for Surgical Implant Applications
4.1.4 Condition (see 5.1),
F 1472 Specification for Wrought Titanium-6Aluminum-
4.1.5 Mechanical properties (if applicable, for special con-
4Vanadium Alloy (UNS R56400) for Surgical Implant
5 ditions),
Applications
1 6
This specification is under the jurisdiction of ASTM Committee F04 on AvailablefromSocietyofAutomotiveEngineers,Inc.,400CommonwealthDr.,
Medical and Surgical Materials and Devices and is the direct responsibility of Warrendale, PA 15096-0001.
Subcommittee F04.12 on Metallurgical Materials. Available from American National Standards Institute, 25 W. 43rd St., 4th
Current edition approved Oct. 10, 2001. Published January 2002. Floor, New York, NY, 10036.
2 8
Annual Book of ASTM Standards, Vol 03.01. Available from American Society for Quality, 600 N. Plankinton Ave.,
Annual Book of ASTM Standards, Vol 03.05. Milwaukee, WI 53203.
4 9
Annual Book of ASTM Standards, Vol 03.06. Available from Standardization Documents Order Desk, Bldg. 4, Section D,
Annual Book of ASTM Standards, Vol 13.01. 700 Robbins Ave., Philadelphia, PA 19111–5098, Attn: NPODS.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 2146
4.1.6 Finish (see 5.2), cal content. The manufacturer shall not ship material that is
4.1.7 Applicable dimensions including outside diameter, outside the limits specified in Table 1. The product analysis
wallthickness,length(exact,random,ormultiples),ordrawing tolerances shall conform to the product tolerances in Table 2.
number, 6.2.1 The product analysis is either for the purpose of
4.1.8 Special tests (see 8.1-8.3), and verifying the composition of a heat or manufacturing lot or to
4.1.9 Other requirements. determine variations in the composition within the heat.
6.2.2 Acceptance or rejection of a heat or manufacturing lot
5. Materials and Manufacture
of material may be made by the purchaser on the basis of this
product analysis.
5.1 Condition:
6.3 For referee purposes, use Test Methods E 120, E 1409,
5.1.1 Annealed—Tubing may be annealed by heating to a
and E 1447 or other analytical methods agreed upon between
temperature within the range 1100 to 1450°F (593 to 788°C),
the purchaser and the supplier.
holding at the selected temperature within 625°F (614°C) for
6.4 Ensure that the samples for chemical analysis are
notlessthan15min,andcoolingatarateequivalenttoaircool
representative of the material being tested. The utmost care
or slower.
must be used in sampling titanium for chemical analysis
5.1.2 Cold-Worked and Stress-Relieved—Tubing may be
because of its affinity for elements such as oxygen, nitrogen,
cold-worked and stress-relieved by heating within the range
and hydrogen. In cutting samples for analysis, therefore, the
700 to 1000°F (371 to 538°C) for not less than 30 min.
operation should be carried out insofar as possible in a
5.2 Finish—Material surfaces will be furnished in accor-
dust-free atmosphere. Cutting tools should be clean and sharp.
dance with the customer order, which may include pickling,
Samples for analysis should be stored in suitable containers.
polishing,orgritblasting,oracombinationoftheseoperations.
5.3 Surface Cleanliness—The inside diameter and outside
7. Mechanical Properties
diameter surfaces of the tubing shall be free from grease and
7.1 The material supplied under this specification shall
other foreign matter. Metallic flakes or particles shall not be
conform to the mechanical property requirements in Table 3.
collected by a clean, white cloth drawn through the bore of a
7.2 Specimensfortensiontestsshallbemachinedandtested
tubesample.Discolorationofthecloth,withoutthepresenceof
in accordance with Test Methods E 8. Tensile properties shall
metallic flakes or particles, is acceptable.
be determined using a strain rate of 0.003 to 0.007 in./in./min
5.4 Dimensional Tolerances—All tolerances shall conform
(mm/mm/min)throughyieldandthenthecrossheadspeedmay
to all applicable requirements of AMS 2244, for standard
be increased so as to produce fracture in approximately one
tolerances.
additional minute.
7.3 Number of Tests—Perform a minimum of two tension
6. Chemical Composition
tests from each lot.Alot is defined as the total number of mill
6.1 The heat analysis shall conform to the chemical com-
products produced under the same conditions at essentially the
positionofTable1.Ingotanalysismaybeusedforreportingall
same time from the same heat. If both test specimens fail, the
chemical requirements, except hydrogen. Samples for hydro-
lot is unacceptable. Should either of the two test specimens not
gen shall be taken from each lot of finished mill product. The
meet the specified requirements, test two additional test pieces
number of samples per lot shall be as agreed upon between the
representative of the same lot in the same manner. The lot will
supplier and the purchaser. The supplier shall not ship mater
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