ASTM F2066-23

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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: F2066 − 18 F2066 − 23
Standard Specification for
Wrought Titanium-15 Molybdenum Alloy for Surgical Implant
Applications (UNS R58150)
This standard is issued under the fixed designation F2066; 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 titanium-15 molybdenum
alloy to be used in the manufacture of surgical implants (1).
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inch-pound units
are to be regarded separately as standard. The values stated in each system may not beare not necessarily exact equivalents;
therefore, to ensure conformance with the standard, each system shall be used independently of each other. Combiningother, and
values from the two systems may result in non-conformance with the standard.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, health, and environmental practices and determine the applicability of
regulatory limitations 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:
E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E112 Test Methods for Determining Average Grain Size
E290 Test Methods for Bend Testing of Material for Ductility
E539 Test Method for Analysis of Titanium Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
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 Reactive Metals and Reactive Metal Alloys by Inert Gas Fusion with
Detection by Thermal Conductivity or Infrared Spectrometry
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)
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 Feb. 15, 2018April 1, 2023. Published March 2015April 2023. Originally approved in 2001. Last previous edition approved in 20132018 as
ɛ1
F2066 – 13F2066 – 18. . DOI: 10.1520/F2066–18.10.1520/F2066-23.
The boldface numbers in parentheses refer to the list of references at the end of this standard.
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.
*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
F2066 − 23
E2994 Test Method for Analysis of Titanium and Titanium Alloys by Spark Atomic Emission Spectrometry and Glow Discharge
Atomic Emission Spectrometry (Performance-Based Method)
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
F1408 Practice for Subcutaneous Screening Test for Implant Materials
IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric
SystemMetric Practice
2.2 Aerospace Material Specifications:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 2631 Ultrasonic Inspection — Titanium Inspection—Titanium and Titanium Alloy Bar and Billet
AMS 2380 Approval and Control of Premium Quality Titanium Alloys
2.3 ISO Standards:
ISO 68926892-1 Metallic Materials — Tensile Materials—Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems Requirements
2.4 American Society for Quality Standard:
ASQ C1 Specification of General Requirements for a Quality Control Program
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 alpha + beta annealed, n—the condition of the material that is obtained if, following the final hot-working or cold-working
operation, the mill product may be rapidly quenched, for example, by water quenching or pressurized helium gas, from a
temperature below the beta transus of approximately 750°C [1382°F].750 °C [1382 °F].
3.1.2 alpha + beta annealed + aged, n—the condition of the material that is obtained by reheating the alpha + beta annealed
material to a time-temperature combination below the beta transus to increase the strength of the alloy.
3.1.3 beta annealed, n—the condition of the material that is obtained if, following the final hot-working or cold-working operation,
the mill product is rapidly quenched, for example, by water quenching or pressurized helium gas quench, from a temperature above
the beta transus of approximately 750°C [1382°F].750 °C [1382 °F].
3.1.4 beta transus, n—the minimum temperature at which the alpha plus beta alpha-plus-beta phase can transform to 100 % beta
phase.
4. Product Classification
4.1 Strip—Any product under 4.76 mm [0.1875 in.] in thickness and under 610 mm [24 in.] wide.
4.2 Sheet—Any product under 4.76 mm [0.1875 in.] in thickness and 610 mm [24 in.] or more in width.
4.3 Plate—Any product 4.76 mm [0.1875 in.] thick and over and 254 mm [10 in.] wide and over, with a width greater than five
times the thickness. Any plate up to 101.60 mm [4 in.], thick [4 in.] thick, inclusive, is covered by this specification.
4.4 Bar—Rounds, flats, or other shapes from 4.76 mm [0.1875 in.] to 101.60 mm [4 in.] in diameter or thickness. (Other sizes and
shapes by special order.)Round, rectangular, or other complex-shaped product delivered straightened and cut to defined lengths.
4.5 Forging Bar—Bar as described in 4.4 used for production of forgings, may be furnished in the hot worked hot-worked
condition.
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.
F2066 − 23
4.6 Wire—Rounds, flats,Round, rectangular, or other shapes less than 4.76 mm [complex shapes of uniform cross section along ⁄16
in.] in diameter or thickness.its entire length furnished in coils, or on spools, reels, or other packaging as specified.
4.7 Other—Other forms and shapes, including tubing, may be provided by agreement between purchaser and supplier.
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 Applicable ASTM designation and date of issue,
5.1.3 Form (strip, sheet, plate, bar, forging bar, wire, other),
5.1.4 Condition (see Section 3 and 6.2),
5.1.5 Mechanical properties (if applicable for special conditions),
5.1.6 Finish (see 6.1),
5.1.7 Applicable dimensions including size, thickness, width, length, or drawing number,
5.1.8 Unit of measurement,
5.1.9 Special tests, if any, and
5.1.10 Special requirements.
6. Materials and Manufacture
6.1 Finish—The mill product may be furnished to the implant manufacturer as descaled or pickled, abrasive-blasted, 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 localized grinding if the resultant area meets the
dimensional and surface finish requirements of this specification.
6.2 Condition:
6.2.1 Beta Annealed—Material shall be furnished in the beta annealed condition. Two classes of beta annealed sheet, strip, and
plate are available. If no class is chosen, Class 1 product shall be provided.
6.2.2 Alpha + Beta Annealed—Material shall be furnished in the alpha + beta annealed condition.
6.2.3 Alpha + Beta Annealed + Aged—Material shall be furnished in the alpha + beta annealed + aged condition.
7. Chemical Requirements
7.1 The heat analysis shall conform to the chemical composition of Table 1. Ingot analysis may be used for reporting all chemical
requirements, except hydrogen. Samples for hydrogen shall be taken from the finished mill product, and the supplier shall not ship
material with chemistry outside the requirements specified in Table 1.
7.1.1 Requirements for the 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 producer is permitted to analyze for unspecified
F2066 − 23
TABLE 1 Chemical Requirements
Element Composition, %, (Mass/Mass)
Nitrogen, max 0.05
Carbon, max 0.10
Hydrogen, max 0.015
Iron, max 0.10
Oxygen, max 0.20
A
Cobalt <0.1
Molybdenum 14.00-16.00
Molybdenum 14.00–16.00
A
Titanium balance
B
Titanium balance
A
Refer to X1.7.
B
Approximately equal to the difference between 100 % and the sum percentage
of the other specified elements. The percentage titanium content by difference is
not required to be reported.
elements and is permitted to report such analyses. The presence of an unspecified element and reporting of an analysis for that
element shall not be a basis for rejection unless previously agreed to between purchaser and supplier.
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, unless previously
agreed to between purchaser and supplier.
7.1.5 Cobalt content must be reported. Refer to X1.7.
7.2 Product (Check) Analysis:
7.2.1 Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations between laboratories
in the measurement of chemical content. The manufacturercheck analysis limits are not for producer’s use as supplier’s/producer’s
acceptance testing. Product analysis limits are not permitted to be applied to ladle or ingot analysis. The supplier/producer shall
not ship material that is outside of the limits specified in Table 1. The product analysisGiven in Table 2 tolerances shall conform
to the product tolerances inis the amount an individual determination for a Table 2.specified element may vary under or over the
specified composition limit. In no case shall the several determinations of any element in a heat, using the same analytical
procedure, vary both above and below the specified range.
7.2.2 The product analysis is (check) analysis is one performed by purchaser or supplier of the metal after it has been worked into
one of the forms specified in Section 4 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.
7.2.3 Acceptance or rejection of a heat or manufacturing lot of material may be made by the purchaser on the basis of this product
(check) analysis. Product (check) analyses outside the tolerancevariation limits allowed in Table 2 are cause for rejection of the
product. A referee analysis may be used if agreed upon by the supplier and purchaser.
TABLE 2 Product Analysis Tolerances(Check) Analysis Variation
A
Limits
ToleranceVariation Under the Minimum or
B
Element
Over the Maximum Limit, , %, % (Mass/
Mass)
Nitrogen 0.02
Carbon 0.02
Hydrogen 0.0020
Iron 0.10
Oxygen 0.02
Cobalt 0.02
Molybdenum 0.25
A
Refer to AMS 2249.
B
Under the minimum limit not applicable for elements in which only a maximum
percentage is indicated.
F2066 − 23
7.2.4 For referee purposes, use Test Methods,Methods E539, E1409, E1447, E1941, E2994, and E2371 or other analytical
methods agreed upon between the purchaser and the supplier.
7.3 Samples for chemical analysis are representative of the material being tested. The utmost care must be used in sampling
titanium for chemical analysis because of its affinity for ability to react with elements such as oxygen, nitrogen, and hydrogen. In
cutting samples for analysis, therefore, 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.
8. Mechanical Requirements
8.1 The material supplied under this specification shall conform to the mechanical property requirements in Table 3 or Table 4.
8.2 Specimens for tension tests shall be machined and tested in accordance with Test Methods E8/E8M. Tensile properties shall
be determined using a strain rate of 0.003 to 0.007 in./in./min [mm/mm/min]mm/mm/min [in./in./min] through the specified yield
and then the crosshead speed shall be increased so as to produce fracture in approximately one additional minute.
8.3 For sheet and strip, the bend test specimen shall withstand being bent cold through an angle of 105° without fracture in the
outside surface of the bend portion. The bend shall be made over a mandrel with a diameter equal to that shown in Table 4. Test
conditions shall conform to Test Method E290.
8.4 Number of Tests:
8.4.1 Bar, Forging Bar, Shapes, and Wire—Test according to Test Methods E8/E8M. Perform at least one tension test from eachthe
lot in the longitudinal direction. Should any test specimen not meet the specified requirements, test two additional test pieces
representative of the same lot, in the same manner, for each failed test specimen. The lot shall be considered in compliance only
if all additional test pieces meet the specified requirements.
8.4.2 Tensile test results for which any specimen fractures outside the gauge length shall be considered acceptable if both the
elongation and the reduction of area meet the minimum requirements specified. specified and all other results conform to Table
3. Refer to sectionssubsections 7.11.4 and 7.12.5 of Test Methods E8/E8M. If either the elongation or reduction of area is less than
the minimum requirement, discard the test and retest. Retest one specimen for each specimen that did not meet the minimum
requirements.
8.4.3 Sheet, Strip, and Plate—Test according to Test Methods E8/E8M. Perform at least one tension test from each lot in the
longitudinal direction. Perform at least one bend test from each lot in both the longitudinal and transverse directions. Tests in the
transverse direction need be made only on product from which a specimen not less than 200 mm (8.0 in.) 200 mm [8.0 in.] in length
for sheet, and 64 mm (2.50 in.)[2.50 in.] in length for plate can be taken. Should any of these test pieces not meet the specified
requirements, test two additional test pieces representative of the same lot, in the same manner,
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