ASTM F2066-07

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

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants. The product shall be classified as: strip; sheet; plate; bar; or wire. The heat analysis shall conform to the chemical composition prescribed. Material shall be furnished in the beta annealed condition. Bend tests and tension tests shall be performed to conform to the specified requirements.
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: 31-Mar-2007
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaces: ASTM F2066-01 - Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
• Effective Date: 01-Apr-2007
• Replaced By: ASTM F2066-08 - Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
• Effective Date: 01-Oct-2008
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Apr-2007
• Referred By: ASTM F620-20 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 01-Apr-2007

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 2066 – 07
Standard Specification for
Wrought Titanium-15 Molybdenum Alloy for Surgical Implant
1
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* F 981 Practice for Assessment of Compatibility of Bioma-
terials for Surgical Implants with Respect to Effect of
1.1 This specification covers the chemical, mechanical, and
Materials on Muscle and Bone
metallurgical requirements for wrought titanium-15 molybde-
F 1408 Practice for Subcutaneous Screening Test for Im-
num alloy to be used in the manufacture of surgical implants
2
plant Materials
(1).
2.2 Aerospace Material Specification:
1.2 The values stated in inch-pound units are to be regarded
AMS 2249 Chemical Check Analysis Limits, Titanium and
as the standard. The SI equivalents in parentheses are for
4
Titanium Alloys
information only.
5
2.3 ISO Standards:
2. Referenced Documents ISO 6892 Metallic Materials — Tensile Testing
3
ISO 9001 Quality Management Systems
2.1 ASTM Standards:
2.4 American Society for Quality Standard:
E8 Test Methods for Tension Testing of Metallic Materials
ASQ C1 Specification of General Requirements for a Qual-
E29 Practice for Using Significant Digits in Test Data to
6
ity Program
Determine Conformance with Specifications
E112 Test Methods for Determining Average Grain Size
3. Terminology
E 290 Test Methods for Bend Testing of Material for
3.1 Definitions of Terms Specific to This Standard:
Ductility
3.1.1 beta annealed, n—the condition of the material that is
E 1409 Test Method for Determination of Oxygen and
obtained if, following the final hot-working or cold-working
Nitrogen inTitanium andTitaniumAlloys by the Inert Gas
operation, the mill product is rapidly quenched, for example,
Fusion Technique
by water quenching or pressurized helium gas quench, from a
E 1447 Test Method for Determination of Hydrogen in
temperature above the beta transus of approximately 1382°F
Titanium and Titanium Alloys by the Inert Gas Fusion
(750°C).
Thermal Conductivity/Infrared Detection Method
3.1.2 beta transus, n—the minimum temperature at which
E 2371 Test Method forAnalysis of Titanium and Titanium
the alpha plus beta phase can transform to 100 % beta phase.
Alloys by Atomic Emission Plasma Spectrometry
F67 Specification for Unalloyed Titanium, for Surgical
4. Product Classification
Implant Applications (UNS R50250, UNS R50400, UNS
4.1 Strip—Any product under 0.1875 in. (4.76 mm) in
R50550, UNS R50700)
thickness and under 24 in. (610 mm) wide.
F 748 Practice for Selecting Generic Biological Test Meth-
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in
ods for Materials and Devices
thickness and 24 in. (610 mm) or more in width.
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and
over and 10 in. (254 mm) wide and over, with widths greater
1
This specification is under the jurisdiction of ASTM Committee F04 on
than five times the thickness. Any plate up to 4 in. (101.60
Medical and Surgical Materials and Devices and is the direct responsibility of
mm), thick inclusive, is covered by this specification.
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved April 1, 2007. Published June 2007. Originally
approved in 2001. Last previous edition approved in 2001 as F 2066 – 01.
2 4
The boldface numbers in parentheses refer to the list of references at the end of Available from Society of Automotive Engineers (SAE), 400 Commonwealth
this standard. Dr., Warrendale, PA 15096-0001, http://www.sae.org.
3 5
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
6
Standards volume information, refer to the standard’s Document Summary page on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
the ASTM website. Milwaukee, WI 53203, http://www.asq.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.
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F2066–07
4.4 Bar—Rounds, flats, or other shapes from 0.1875 in. specified in Table 1. The product analysis tolerances shall
(4.76 mm) to 4 in. (101.60 mm) in diameter or thickness. conform to the product tolerances in Table 2.
(Other sizes and shapes by special order.) 7.2.2 The product analysis is either for the
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