ASTM F2066-23

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).2  
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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of each 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, 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.

General Information

• Status: Published
• Publication Date: 31-Mar-2023
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Refers: ASTM F1408-20 - Standard Practice for Subcutaneous Screening Test for Implant Materials
• Effective Date: 01-Jun-2020
• Refers: ASTM F1408-20a - Standard Practice for Subcutaneous Screening Test for Implant Materials
• Effective Date: 01-Aug-2020

Standards Content (Sample)

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.
Designation: F2066 − 23
Standard Specification for
Wrought Titanium-15 Molybdenum Alloy for Surgical Implant
1
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* E290 Test Methods for Bend Testing of Material for Ductil-
ity
1.1 This specification covers the chemical, mechanical, and
E539 Test Method for Analysis of Titanium Alloys by
metallurgical requirements for wrought titanium-15 molybde-
Wavelength Dispersive X-Ray Fluorescence Spectrometry
num alloy to be used in the manufacture of surgical implants
2 E1409 Test Method for Determination of Oxygen and Nitro-
(1).
gen in Titanium and Titanium Alloys by Inert Gas Fusion
1.2 The values stated in either SI units or inch-pound units
E1447 Test Method for Determination of Hydrogen in Re-
are to be regarded separately as standard. The values stated in
active Metals and Reactive Metal Alloys by Inert Gas
each system are not necessarily exact equivalents; therefore, to
Fusion with Detection by Thermal Conductivity or Infra-
ensure conformance with the standard, each system shall be
red Spectrometry
used independently of each other, and values from the two
E1941 Test Method for Determination of Carbon in Refrac-
systems shall not be combined.
tory and Reactive Metals and Their Alloys by Combustion
1.3 This standard does not purport to address all of the
Analysis
safety concerns, if any, associated with its use. It is the E2371 Test Method for Analysis of Titanium and Titanium
responsibility of the user of this standard to establish appro-
Alloys by Direct Current Plasma and Inductively Coupled
priate safety, health, and environmental practices and deter- Plasma Atomic Emission Spectrometry (Performance-
mine the applicability of regulatory limitations prior to use.
Based Test Methodology)
1.4 This international standard was developed in accor- E2994 Test Method for Analysis of Titanium and Titanium
dance with internationally recognized principles on standard-
Alloys by Spark Atomic Emission Spectrometry and Glow
ization established in the Decision on Principles for the Discharge Atomic Emission Spectrometry (Performance-
Development of International Standards, Guides and Recom-
Based Method)
mendations issued by the World Trade Organization Technical
F67 Specification for Unalloyed Titanium, for Surgical Im-
Barriers to Trade (TBT) Committee. plant Applications (UNS R50250, UNS R50400, UNS
R50550, UNS R50700)
2. Referenced Documents
F748 Practice for Selecting Generic Biological Test Methods
3
for Materials and Devices
2.1 ASTM Standards:
F981 Practice for Assessment of Compatibility of Biomate-
E8/E8M Test Methods for Tension Testing of Metallic Ma-
rials for Surgical Implants with Respect to Effect of
terials
Materials on Muscle and Insertion into Bone
E29 Practice for Using Significant Digits in Test Data to
F1408 Practice for Subcutaneous Screening Test for Implant
Determine Conformance with Specifications
Materials
E112 Test Methods for Determining Average Grain Size
IEEE/ASTM SI 10 American National Standard for Metric
Practice
4
2.2 Aerospace Material Specifications:
1
This specification is under the jurisdiction of ASTM Committee F04 on
AMS 2249 Chemical Check Analysis Limits, Titanium and
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Titanium Alloys
Current edition approved April 1, 2023. Published April 2023. Originally
AMS 2631 Ultrasonic Inspection—Titanium and Titanium
approved in 2001. Last previous edition approved in 2018 as F2066 – 18. DOI:
Alloy Bar and Billet
10.1520/F2066-23.
2
The boldface numbers in parentheses refer to the list of references at the end of AMS 2380 Approval and Control of Premium Quality Tita-
this standard.
nium Alloys
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
4
Standards volume information, refer to the standard’s Document Summary page on Available from Society of Automotive Engineers (SAE), 400 Commonwealth
the ASTM website. Dr., Warrendale, PA 15096-0001, http://www.sae.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
1

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This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
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
1
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
2
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
3
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)
1
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.
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. 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
1

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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): Th
...