ASTM F2066-00

Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

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 values stated in inch pound units are to be regarded as the standard. The SI equivalents in parentheses are for information only.

General Information

• Status: Historical
• Publication Date: 09-May-2001
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaced By: ASTM F2066-01 - Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
• Effective Date: 10-May-2001
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 10-May-2001
• Referred By: ASTM F620-20 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 10-May-2001

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 2066 – 00
Standard Specification for
Wrought Titanium-15 Molybdenum Alloy for Surgical Implant
Applications (UNS R58150)
This standard is issued under the fixed designation F 2066; 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 AMS 2249 Chemical Check Analysis Limits, Titanium and
Titanium Alloys
1.1 This specification covers the chemical, mechanical, and
2.3 American Society for Quality Standard:
metallurgical requirements for wrought titanium-15 molybde-
ASQ C1 Specification of General Requirements for a Qual-
num alloy to be used in the manufacture of surgical implants
ity Program
(1).
1.2 The values stated in inch pound units are to be regarded
3. Terminology
as the standard. The SI equivalents in parentheses are for
3.1 Definitions of Terms Specific to This Standard:
information only.
3.1.1 beta annealed, n—The condition of the material that is
2. Referenced Documents obtained if, following the final hot-working or cold-working
operation, the mill product is rapidly quenched, for example,
2.1 ASTM Standards:
3 by water quenching or pressurized helium gas quench, from a
E 8 Test Methods for Tension Testing of Metallic Materials
temperature above the beta transus of approximately 1382°F
E 112 Test Methods for Determining the Average Grain
3 (750°C).
Size
3.1.2 beta transus, n—The minimum temperature at which
E 120 Test Methods for Chemical Analysis of Titanium and
4 the alpha plus beta phase can transform to 100 % beta phase.
Titanium Alloys
E 1409 Test Method for Determination of Oxygen in Tita-
4. Product Classification
nium and Titanium Alloys by the Inert Gas Fusion Tech-
5 4.1 Strip—Any product under 0.1875 in. (4.76 mm) in
nique
thickness and under 24 in. (610 mm) wide.
E 1447 Test Method for Determination of Hydrogen in
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in
Titanium and Titanium Alloys by the Inert Gas Fusion
thickness and 24 in. (610 mm) or more in width.
Thermal Conductivity Method
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and
F 67 Specification for Unalloyed Titanium for Surgical
over and 10 in. (254 mm) wide and over, with widths greater
Implant Applications
than five times thickness. Plate up to 4 in. (101.60 mm), thick
F 748 Practice for Selecting Generic Biological Test Meth-
inclusive, is covered by this specification.
ods for Materials and Devices
4.4 Bar—Rounds or flats from ⁄16 in. (4.76 mm) to 4 in.
F 981 Practice for Assessment of Compatibility of Bioma-
(101.60 mm) in diameter or thickness. (Other sizes and shapes
terials for Surgical Implants with Respect to Effect of
6 by special order.)
Materials on Muscle and Bone
4.5 Wire—Rounds or flats less than ⁄16 in. (4.76 mm) in
F 1408 Practice for Subcutaneous Screening Test for Im-
6 diameter or thickness.
plant Materials
2.2 Aerospace Material Specification:
5. Ordering Information
5.1 Include with inquiries and orders for material under this
specification the following information.
5.1.1 Quantity,
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
5.1.2 Applicable ASTM designation,
Subcommittee F04.12 on Metallurgical Materials.
5.1.3 Form (strip, sheet, plate, bar, or wire),
Current edition approved November 10, 2000. Published January 2001.
2 5.1.4 Condition (see 3 and 6.1),
The boldface numbers in parentheses refer to the list of references at the end of
the text.
Annual Book of ASTM Standards, Vol 03.01.
Annual Book of ASTM Standards, Vol 03.05.
5 7
Annual Book of ASTM Standards, Vol 03.06. Available from the American Society of Automotive Engineers, 400 Common-
Annual Book of ASTM Standards, Vol 13.01. wealth Drive, Warrendale, PA 15096.
Available from the American Society for Quality, 161 W. Wisconsin Ave.,
Milwaukee, WI 53203.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 2066
A
TABLE 2 Product Analysis Tolerances
5.1.5 Mechanical Properties (if applicable for special con-
ditions), Tolerance Under the Minimum or Over the
Element
B
Maximum Limit , %, (mass/mass)
5.1.6 Finish (see 6.2),
Nitrogen 0.02
5.1.7 Applicable dimension including size, thickness, width,
Carbon 0.02
or drawing number,
Hydrogen 0.0020
5.1.8 Special tests, if any, and
Iron 0.10
Oxygen 0.02
5.1.9 Special requirements.
Molybdenum 0.25
A
Refer to AMS 2249.
6. Materials and Manufacture
B
Under the minimum limit not applicable for elements where only a maximum
6.1 The various titanium mill products covered in this
percentage is indicated.
specification normally are formed with the conventional forg-
ing and rolling equipment found in primary ferrous and
nonferrous plants. The alloy is usually multiple melted in arc
and hydrogen. In cutting samples for analysis, therefore, the
furnaces (including furnaces such as plasma arc and electron
operation should be carried out insofar as possible in a
beam) of a type conventionally used for reactive metals.
dust-free atmosphere. Cutting tools should be clean and sharp.
6.2 Finish—The mill product may be furnished to the
Samples for analysis should be stored in suitable containers.
implant manufacturer as descaled or pickled, sandblasted,
chemically milled, ground, machined, peeled, polished, or
8. Mechanical Requirements
combinations of these operations.
8.1 The material supplied under this specification shall
conform to the mechanical property requirements in Table 3 or
7. Chemical Requirements
Table 4.
7.1 The heat analysis shall conform to the chemical com-
8.2 Specimens for tension tests shall be machined and tested
position of Table 1. Ingot analysis may be used for reporting all
in accordance with Test Methods E 8. Tensile properties shall
chemical requirements, except hydrogen. Samples for hydro-
be determined using a strain rate of 0.003 to 0.007 in./in./
gen shall be taken from the finished mill product.
minute (mm/mm/min) through the specified yield and then the
7.1.1 Requirements for the major and minor elemental
crosshead speed shall be increased so as to produce fracture in
constituents are listed in Table 1. Also listed are important
approximately one additional minute.
residual elements. Analysis for elements not listed in Table 1 is
8.3 Number of Tests—Perform a minimum of two tension
not required to verify compliance with this specification.
tests from each lot. A lot is defined as the total number of mill
7.2 Product Analysis—Product analysis tolerances do not
products produced under the same conditions at essentially the
broaden the specified heat analysis requirements but cover
same time. Should either of the two test specimens not meet the
variations between laboratories in the measurement of chemi-
specified requirements, test two additional test pieces represen-
cal content. The manufacturer shall not ship material that is
tative of the same lot in the same manner. The lot will be
outside the limits specified in Table 1. The product analysis
considered in compliance only if both additional test pieces
tolerances shall conform to the check tolerances in Table 2.
meet the specified requirements. If a specimen fails outside the
7.2.1 The product analysis is either for the purpose of
gage, the test is null in accordance with Test Methods E 8, and
verifying the composition of a heat or lot or to determine
a retest shall be performed.
variations in the composition within the heat.
7.2.2 Acceptance or rejection of a heat or lot of material
9. Special Requirements
may be made by the purchaser on the basis of this check
9.1 The microstructure shall consist of a fully recrystallized
analysis.
beta phase structure. Primary alpha and alpha prime (also
7.3 For referee purposes, use Test Methods E 120, E 1409,
known as martensitic alpha) are not permitted in the micro-
and E 1447 or other analytical methods agreed upon between
structure w
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