ASTM F2146-22

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it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2146 − 13 F2146 − 22
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 F2146; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope*
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought and 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 4 for size limitations.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each
system aremay not necessarilybe exact equivalents; therefore, to ensure conformance with the standard, each system shall be used
independently of the other, and values from the two systems shall not be combined.
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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory requirementslimitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
B367 Specification for Titanium and Titanium Alloy Castings
E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas Fusion
E1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
E1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Direct Current Plasma and Inductively Coupled Plasma
Atomic Emission Spectrometry (Performance-Based Test Methodology)
E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals (Withdrawn 2017)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved March 1, 2013Jan. 1, 2022. Published April 2013January 2022. Originally approved in 2001. Last previous edition approved in 20072013 as
F2146 – 07.F2146 – 13. DOI: 10.1520/F2146-13.10.1520/F2146-22.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
The last approved version of this historical standard is referenced on www.astm.org.
*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
F2146 − 22
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
IEEE/ASTM SI 10 American National Standard for Metric Practice
2.2 Aerospace Material Specifications:
AMS 2244 Tolerances, Titanium and Titanium Alloy Tubing
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 2634 Ultrasonic Inspection, Thin Wall Metal Tubing
AMS 4943 Titanium Alloy, Seamless, Hydraulic Tubing, 3.0A1-2.5V Annealed
AMS 4944 Titanium Alloy, Seamless, Hydraulic Tubing, 3.0A1-2.5V Cold-Worked, Stress-Relieved
AMS 6940 Titanium Alloy Bars, Forgings, and Forging Stock, 3.0Al-2.5V Annealed-UNS R56320
2.3 ISO Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems Requirements
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
F2146 − 22
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 beta transus, n—the minimum temperature at which the alpha plus beta alpha-plus-beta phase can transform to 100 % beta
phase on heating.
3.1.2 cold work, n—any mechanical deformation process performed below the recrystallization temperature which results in strain
hardening of the material.
3.1.3 lot, n—total number of tubes produced from the same heat under the same conditions at essentially the same time.
4. Product Classification
4.1 Tubing—Tubular product with an outside diameter greater than 0.250 in. [6.35 mm].6.35 mm [0.250 in.].
5. Ordering Information
5.1 Include with inquiries and orders for material under this specification the following information:
5.1.1 Quantity,
5.1.2 ASTM designation and date of issue (for example, F2146–13),F2146–22),
5.1.3 Form (seamless tubing),
5.1.4 Applicable dimensions including outside diameter, wall thickness, length (exact, random, or multiples), or drawing number,
5.1.5 Finish (see 6.1),
5.1.6 Condition (see 6.2),
5.1.7 Mechanical properties (if applicable, for special conditions),
5.1.8 Special tests (see Section 10), and
5.1.9 Other requirements.
6. Materials and Manufacture
6.1 Finish—The mill product shall be furnished to the implant manufacturer as descaled or pickled, abrasive blasted, chemically
milled, ground, machined, peeled, polished, or as specified by the purchaser.
6.2 Condition:
6.2.1 Annealed—Tubing may be annealed by heating to a temperature within the range of 1100593 to 1450°F [593788 °C [1100
to 788°C],1450 °F], holding at the selected temperature within 625°F [614°C]614 °C [625 °F] for not less than 15 min, and
cooling at a rate equivalent to air cool or slower.
6.2.2 Cold-Worked and Stress-Relieved—Tubing may be cold-worked then stress-relieved by heating within the range 700 to
1000°F [371 to 538°C]of 371 to 538 °C [700 to 1000 °F] for not less than 30 min.
6.3 Surface Cleanliness—The inside and outside surfaces of the 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. Discoloration of the cloth,
without the presence of metallic flakes or particles, is acceptable.
6.4 Dimensional Tolerances—All tolerances shall conform to all applicable requirements of AMS 2244,2244 for standard
tolerances.
F2146 − 22
7. Chemical Composition
7.1 The supplier’s heat analysis shall conform to the chemical composition of prescribed in Table 1. Ingot analysis may be used
for reporting all chemical requirements, except hydrogen. Samples for hydrogen shall be taken from each lot of finished mill
product. The number of samples per lot shall be as agreed upon between the supplier and the purchaser. The supplier shall not ship
material with a composition outside the requirements specified in Table 1.
7.1.1 Requirements for major and minor elemental constituents are listed in Table 1. Also listed are important residual elements.
Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.
7.1.2 All commercial metals may contain small amounts of elements other than those which are specified. It is neither practical
nor necessary to specify limits for unspecified elements that can be present. The supplier/producer is permitted to analyze for
unspecified elements and is permitted to report such analyses. The presence of an unspecified element and the reporting of an
analysis for that element shall not be a basis for rejection unless previously agreed to between supplier and purchaser.
7.1.3 Intentional elemental additions other than those specified in Table 1 are not permitted.
7.1.4 Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.
7.1.5 Methods and practices relating to chemical analysis required by this specification shall be tested in accordance with Test
Methods E1409, E1447, E1941, E2371, and Guide E2626.
7.2 Product (Check) Analysis:
7.2.1 The product (check) analysis tolerances shall conform to the product tolerances in Table 2 per AMS 2249. Product analysis
tolerances do not broaden the specified heat (ladle or ingot) analysis requirements but cover variations between laboratories in the
measurement of chemical content between laboratories. The product analysis tolerances shall conform to the product tolerances
in content. Table 2.
7.2.2 Product (check) analysis limits are not for supplier’s/producer’s use at supplier’s/producer’s acceptance testing. Product
analysis tolerances are not permitted to be applied to ladle or ingot analysis. The supplier/producer shall not ship material that is
outside the limits specified in Table 1.
7.2.3 TheA product analysis is (check) analysis is one performed by purchaser or supplier of the metal after it has been worked
into semi-finished or finished forms or fabricated into parts, and is either for the purpose of verifying the composition of a heat
or manufacturing lot or to determine variations in the composition within the heat. In the analysis of finished parts, these values
TABLE 1 Chemical RequirementsRequirements, Heat Analysis
Composition, % (mass/mass)
Element
Minimum Maximum
Nitrogen . . . 0.020
Carbon . . . 0.050
Hydrogen . . . 0.015
Iron . . . 0.30
Oxygen . . . 0.12
Aluminum 2.50 3.50
Vanadium 2.00 3.00
Yttrium . . . 0.005
Cobalt . . . <0.1 %
B
Other elements each . . . 0.10
Other elements total . . . 0.4
A
Titanium balance balance
A
The percentage of titanium is determined by difference and need not be
determined directly or certified.
B
Other elements need not be reported unless the concentration level is greater
than 0.1 % each, or 0.4 % total. Other elements may not be added intentionally.
Other elements may be present in titanium or titanium alloys in small quantities
and are inherent to the manufacturing process. In titanium these elements typically
include aluminum, vanadium, tin, chromium, molybdenum, niobium, zirconium,
hafnium, bismuth, ruthenium, palladium, yttrium, copper, silicon, cobalt, tantalum,
nickel, boron, manganese, and tungsten.
F2146 − 22
A
TABLE 2 Product Analysis Tolerances
Tolerance Under the Minimum
Element
B
or Over the Maximum Limit
Nitrogen 0.02
Carbon 0.02
Hydrogen 0.0020
Iron 0.10
Oxygen (up to 0.20) 0.02
Aluminum 0.40
Vanadium 0.15
Yttrium 0.0006
C
Cobalt 0.02
A
Refer to AMS 2249.
B
Under the minimum limit not applicable for elements where only a maximum limit
is indicated.
C
Refer to Specification B367, Table 2 “Other (Each).”
do not apply to elements whose percentage can be varied by fabricating techniques employed (for example oxygen, nitrogen,
hydrogen) unless the sample is sufficiently large to produce a reliable result.
7.2.4 Acceptance or rejection of a heat or manufacturing lot of material may be made by the purchaser on the basis of this product
analysis. Product (check) analyses outside the tolerance limits allowed in Table 2 are cause for rejection of the product. A referee
analysis may be used if agreed upon by supplier and purchaser.
7.2.5 Samples for chemical analysis shall be representative of the material being tested. The utmost care must be used in sampling
titanium for chemical analysis because of its ability to react with elements such as oxygen, nitrogen, and hydrogen. Therefore,
when cutting samples for analysis, the operation should be carried out insofar as possible in a dust-free atmosphere. Cutting tools
should be clean and sharp. Samples for analysis should be stored in suitable containers.
7.2.6 For referee purposes, use Test Methods E1409, E1447, E1941, E2371, and Guide E2626 or other analytical methods agreed
upon between 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 s
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