ASTM F1472-14

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

ABSTRACT
This specification covers the requirements for wrought titanium-6aluminum-4vanadium alloy for use in surgical implant applications. The material shall be manufactured by multiple melting in plasma arc and electron beam furnaces into strip, sheet, plate, bar, forging bar, or wire. The material shall be available in the annealed or cold-worked condition, with the surface mechanically descaled or pickled, sandblasted, chemically milled, ground, machined, peeled, polished, or a combination of these. Heat and product analyses as well as tension and bend (for sheet, strip, and plate) tests shall be performed and shall conform to the requirements specified. In addition, the material shall have a microstructure consisting of a fine dispersion of alpha and beta phases as a result of processing in the alpha plus beta field, with no continuous alpha network at prior beta grain boundaries and no coarse, elongated alpha platelets.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium alloy (UNS R56400) to be used in the manufacture of surgical implants.  
1.2 Units—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 from the two systems may result in non-conformance with the standard.

General Information

• Status: Historical
• Publication Date: 14-Nov-2014
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F1472 −14
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical
1
Implant Applications (UNS R56400)
This standard is issued under the fixed designation F1472; 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* E2371Test Method for Analysis of Titanium and Titanium
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
1.1 This specification covers the chemical, mechanical, and
Plasma Atomic Emission Spectrometry (Performance-
metallurgical requirements for wrought annealed titanium-
Based Test Methodology)
6aluminum-4vanadium alloy (UNS R56400) to be used in the
E2626Guide for Spectrometric Analysis of Reactive and
manufacture of surgical implants.
Refractory Metals
1.2 Units—The values stated in either SI units or inch-
F136 Specification for Wrought Titanium-6Aluminum-
pound units are to be regarded separately as standard. The
4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
values stated in each system may not be exact equivalents;
Implant Applications (UNS R56401)
3
therefore,eachsystemshallbeusedindependentlyoftheother.
2.2 Aerospace Material Specifications:
Combining values from the two systems may result in non-
AMS 2249 Chemical CheckAnalysis Limits, Titanium and
conformance with the standard.
Titanium Alloys
AMS 2631Ultrasonic Inspection Titanium, and Titanium
2. Referenced Documents
Alloy Bar, Billet, and Plate
2
2.1 ASTM Standards:
AMS 4911Titanium Alloy Sheet, Strip, and Plate 6Al-4V
E8/E8MTest Methods for Tension Testing of Metallic Ma-
Annealed
terials
AMS 4928TitaniumAlloy Bars,Wire, Forgings, Rings, and
E29Practice for Using Significant Digits in Test Data to
Drawn Shapes 6Al-4VAnnealed
Determine Conformance with Specifications
AMS 4965TitaniumAlloy, Bars,Wire, Forgings, and Rings
E290Test Methods for Bend Testing of Material for Ductil-
6.0 Al 4.0 V Solution Heat Treated and Aged
4
ity
2.3 ISO Standards:
E539TestMethodforAnalysisofTitaniumAlloysbyX-Ray
ISO 5832–3Implants for Surgery—Metallic Materials—
Fluorescence Spectrometry
Part 3, Wrought Titanium-6Aluminum-4Vanadium Alloy
E527Practice for Numbering Metals and Alloys in the
ISO 6892Metallic Materials—Tensile Testing at Ambient
Unified Numbering System (UNS)
Temperature
E1409TestMethodforDeterminationofOxygenandNitro-
ISO 9001Quality Management Systems—Requirements
3,5
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
2.4 Society of Automotive Engineers Standard:
E1447Test Method for Determination of Hydrogen in Tita-
SAE J1086Practice for Numbering Metals and Alloys
nium and Titanium Alloys by Inert Gas Fusion Thermal
(UNS)
Conductivity/Infrared Detection Method
3. Terminology
E1941Test Method for Determination of Carbon in Refrac-
toryandReactiveMetalsandTheirAlloysbyCombustion
3.1 Definitions of Terms Specific to This Standard:
Analysis
3.1.1 beta transus, n—the minimum temperature at which
the alpha plus beta phase can transform to 100 % beta phase.
3.1.2 lot, n—the total number of mill products produced
1
This specification is under the jurisdiction of ASTM Committee F04 on
fromoneheatunderthesameconditionsatessentiallythesame
Medical and Surgical Materials and Devices and is the direct responsibility of
time.
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Nov. 15, 2014. Published February 2015. Originally
ε1
published in 1993. Last previous edition approved in 2008 as F1472– 08 . DOI:
3
10.1520/F1472-14. Available from Society of Automotive Engineers (SAE), 400 Commonwealth
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Dr., Warrendale, PA 15096-0001, http://www.sae.org.
4
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Standards volume information, refer to the standard’s Document Summary page on 4th Floor, New York, NY 10036, http://www.ansi.org.
5
the ASTM website. NewdesignationestablishedinaccordancewithPracticeE527andSAEJ1086.
*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 ----------------------
F1472−14
3.1.3 stress relieved—heated to a temperature below the 6.3 Condition—Material shall be furnished in the annealed,
annealing temperature with no observable change in micro- stress relieved, or cold-worked or hot worked condition.
structure. Mechanical properties for conditions other than those listed in
Table 3 may be established by agreement between the supp
...

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.
´1
Designation: F1472 − 08 F1472 − 14
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical
1
Implant Applications (UNS R56400)
This standard is issued under the fixed designation F1472; 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
ε NOTE—Editorially corrected the ISO 5832–3 designation throughout in December 2008.
1. Scope*
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-
6aluminum-4vanadium alloy (UNS R56400) to be used in the manufacture of surgical implants.
1.2 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values given
in parentheses are mathematical conversions to SI units that are provided for information only and are not considered stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in non-conformance with the standard.
2. Referenced Documents
2
2.1 ASTM Standards:
E8E8/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 X-Ray Fluorescence Spectrometry
E527 Practice for Numbering Metals and Alloys in the Unified Numbering System (UNS)
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)
E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
3
2.2 ASQ Standard:
ASQ C1 Specifications of General Requirements for a Quality Program
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 Oct. 1, 2008Nov. 15, 2014. Published October 2008February 2015. Originally published in 1993. Last previous edition approved in 20022008
ε1
as F1472 – 02a.F1472 – 08 . DOI: 10.1520/F1472-08E01.10.1520/F1472-14.
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 ----------------------
F1472 − 14
3
2.2 Aerospace Material Specifications:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 2631 Ultrasonic Inspection Titanium, and Titanium Alloy Bar, Billet, and Plate
AMS 4911 Titanium Alloy Sheet, Strip, and Plate 6Al-4V Annealed
AMS 4928 Titanium Alloy Bars, Wire, Forgings, Rings, and Drawn Shapes 6Al-4V Annealed
AMS 4965 Titanium Alloy, Bars, Wire, Forgings, and Rings 6.0Al-4.0V 6.0 Al 4.0 V Solution Heat Treated and Aged
4
2.3 ISO Standards:
ISO 5832–3 Implants for Surgery—Metallic Materials—Part 3, Wrought Titanium-6Aluminum-4Vanadium Alloy
ISO 6892 Metallic Materials—Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems—Requirements
3,5
2.4 Society of Automotive Engineers Standard:
SAE J1086 Practice for Numbering Metals and Alloys (UNS)
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 phase can transform to 100 % beta phase.
3.1.2 lot, n—the total number of mill products produced from one heat un
...