ASTM F3046-21

Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320)

ABSTRACT
This specification establishes the chemical, physical, mechanical, and metallurgical requirements for wrought titanium-3aluminum-2.5vanadium alloy (R56320) to be used in the manufacture of surgical implants. It covers various titanium mill products that are normally formed with the conventional forging and rolling equipment found in primary ferrous and nonferrous plants. The alloy is usually multiple melted in arc furnaces (including furnaces such as plasma arc and electron beam) of a type conventionally used for reactive metals.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-3aluminum-2.5vanadium alloy (R56320) to be used in the manufacture of surgical implants.  
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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values of the two systems may result in nonconformance within the standard.  
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: 30-Sep-2021
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

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:F3046 −21
Standard Specification for
Wrought Titanium-3Aluminum-2.5Vanadium Alloy for
1
Surgical Implant Applications (UNS R56320)
This standard is issued under the fixed designation F3046; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* E539Test Method for Analysis of Titanium Alloys by
WavelengthDispersiveX-RayFluorescenceSpectrometry
1.1 This specification covers the chemical, mechanical, and
E1409TestMethodforDeterminationofOxygenandNitro-
metallurgical requirements for wrought titanium-3aluminum-
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
2.5vanadium alloy (R56320) to be used in the manufacture of
E1447Test Method for Determination of Hydrogen in Tita-
surgical implants.
nium and Titanium Alloys by Inert Gas Fusion Thermal
1.2 The values stated in either SI units or inch-pound units
Conductivity/Infrared Detection Method
are to be regarded separately as standard. The values stated in
E1941Test Method for Determination of Carbon in Refrac-
each system may not be exact equivalents; therefore, each
toryandReactiveMetalsandTheirAlloysbyCombustion
system shall be used independently of the other. Combining
Analysis
values of the two systems may result in nonconformance
E2371Test Method for Analysis of Titanium and Titanium
within the standard.
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
1.3 This standard does not purport to address all of the
Plasma Atomic Emission Spectrometry (Performance-
safety concerns, if any, associated with its use. It is the Based Test Methodology)
responsibility of the user of this standard to establish appro-
E2994Test Method for Analysis of Titanium and Titanium
priate safety, health, and environmental practices and deter- AlloysbySparkAtomicEmissionSpectrometryandGlow
mine the applicability of regulatory limitations prior to use.
Discharge Atomic Emission Spectrometry (Performance-
1.4 This international standard was developed in accor- Based Method)
3
dance with internationally recognized principles on standard-
2.2 ISO Standards:
ization established in the Decision on Principles for the
ISO 6892Metallic Materials Tensile Testing at Ambient
Development of International Standards, Guides and Recom-
Temperature
mendations issued by the World Trade Organization Technical
ISO 9001Quality Management Systems—Requirements
Barriers to Trade (TBT) Committee.
ISO 13485 Medical Devices—Quality Management
Systems—Requirements for Regulatory Purposes
2. Referenced Documents
4
2.3 Aerospace Material Specifications:
2
2.1 ASTM Standards:
AMS 2249Chemical Check Analysis Limits, Titanium and
B367Specification for Titanium and Titanium Alloy Cast-
Titanium Alloys
ings
AMS 2631Ultrasonic Inspection—Titanium and Titanium
E8/E8MTest Methods for Tension Testing of Metallic Ma-
Alloy Bar and Billet
terials
E29Practice for Using Significant Digits in Test Data to
3. Terminology
Determine Conformance with Specifications
3.1 Definitions of Terms Specific to This Standard:
E290Test Methods for Bend Testing of Material for Ductil-
3.1.1 beta transus, n—the minimum temperature at which
ity
the alpha-plus-beta phase can transform to 100% beta phase.
1
3.1.2 lot, n—the total number of mill products produced
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
fromoneheatunderthesameconditionsatessentiallythesame
Subcommittee F04.12 on Metallurgical Materials.
time.
Current edition approved Oct. 1, 2021. Published November 2021. Originally
approved in 2013. Last previous edition approved in 2013 as F3046–13. DOI:
10.1520/F3046-21.
2 3
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.
4
Standards volume information, refer to the standard’s Document Summary page on AvailablefromSAEInternational(SAE),400CommonwealthDr.,Warrendale,
the ASTM website. 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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F3046−21
4. Product Classification peeled, polished, combinations of these operations, or
...

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: F3046 − 13 F3046 − 21
Standard Specification for
Wrought Titanium-3Aluminum-2.5Vanadium Alloy for
1
Surgical Implant Applications (UNS R56320)
This standard is issued under the fixed designation F3046; 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 Scope*
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-3aluminum-
2.5vanadium alloy (R56320) to be used in the manufacture of surgical implants.
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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values of the
two systems may result in nonconformance within the standard.
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
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
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 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)
E2994 Test Method for Analysis of Titanium and Titanium Alloys by Spark Atomic Emission Spectrometry and Glow Discharge
Atomic Emission Spectrometry (Performance-Based Method)
1
This test method 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 Dec. 1, 2013Oct. 1, 2021. Published January 2014November 2021. Originally approved in 2013. Last previous edition approved in 2013 as
F3046 – 13. DOI: 10.1520/F3046-13.10.1520/F3046-21.
2
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

---------------------- Page: 1 ----------------------
F3046 − 21
3
2.2 ISO Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems RequirementsSystems—Requirements
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
4
2.3 ASQ Standard:
ASQ C1 Specifications of General Requirements for a Quality Control Program
4
2.3 Aerospace Material Specifications:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 2631 Ultrasonic Inspection—Titanium and Titanium Alloy Bar and Billet
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.
3.1.2 lot, n—the total number of mill products produced from one heat un
...