ASTM F1295-16

Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold worked, or hot rolled titanium-6aluminum-7niobium alloy (UNS R56700) bar and wire to be used in the manufacture of surgical implants. Titanium mill products covered in this specification shall be formed with the conventional forging and rolling equipment found in primary ferrous and nonferrous plants, and may be furnished as descaled or pickled, sandblasted, chemically milled, ground, machined, peeled, polished, or cold drawn. The alloy shall be multiple melted in arc furnaces (including furnaces such as plasma arc and electron beam) of a type conventionally used for reactive metals. Heat analysis shall conform to the chemical composition requirements prescribed for aluminum, niobium, tantalum, iron, oxygen, carbon, nitrogen, hydrogen, and titanium. The material shall conform to the specified requirements for mechanical properties such as ultimate tensile strength, yield strength, and elongation. A minimum of two tension tests from each lot shall be performed. Special requirements for the microstructure are detailed as well.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold-worked, or hot-worked titanium-6aluminum-7niobium alloy bar, wire, sheet, strip, and plate to be used in the manufacture of surgical implants (1-4).2  
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 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: 30-Sep-2016
• 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F1295 −16
Standard Specification for
Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical
1
Implant Applications (UNS R56700)
This standard is issued under the fixed designation F1295; 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-
metallurgicalrequirementsforwroughtannealed,cold-worked,
Based Test Methodology)
or hot-worked titanium-6aluminum-7niobium alloy bar, wire,
E2626Guide for Spectrometric Analysis of Reactive and
sheet, strip, and plate to be used in the manufacture of surgical
2 Refractory Metals
implants (1-4).
IEEE/ASTM SI 10American National Standard for Use of
1.2 The SI units in this standard are the primary units. The
theInternationalSystemofUnits(SI):TheModernMetric
values stated in either primary SI units or secondary inch-
System
pound units are to be regarded separately as standard. The
4
2.2 Aerospace Material Specification:
values stated in each system may not be exact equivalents;
AMS 2249Chemical Check Analysis Limits, Titanium and
therefore,eachsystemshallbeusedindependentlyoftheother.
Titanium Alloys
Combining values from the two systems may result in non-
AMS 2630Inspection, Ultrasonic Product Over 0.5 Inch
conformance with the standard.
(12.7 mm) Thick
AMS 2631Ultrasonic Inspection--Titanium and Titanium
2. Referenced Documents
Alloy Bar and Billet
3
2.1 ASTM Standards:
5
2.3 ISO Standards:
E8/E8MTest Methods for Tension Testing of Metallic Ma-
ISO 5832–11Implants for Surgery—Metallic Materials—
terials
Part 11: Wrought Titanium 6–Aluminum 7–Niobium Al-
E29Practice for Using Significant Digits in Test Data to
loy
Determine Conformance with Specifications
ISO 6892–1Metallic Materials—Tensile Testing—Part 1:
E290Test Methods for Bend Testing of Material for Ductil-
Method of Test at Room Temperature
ity
ISO 9001Quality Management Systems—Requirements
E1409TestMethodforDeterminationofOxygenandNitro-
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
3. Terminology
E1447Test Method for Determination of Hydrogen in Tita-
3.1 Definitions of Terms Specific to This Standard:
nium and Titanium Alloys by Inert Gas Fusion Thermal
3.1.1 beta transus, n—the minimum temperature at which
Conductivity/Infrared Detection Method
the alpha plus beta phase can transform to 100% beta phase.
E1941Test Method for Determination of Carbon in Refrac-
toryandReactiveMetalsandTheirAlloysbyCombustion 3.1.2 cold work—any mechanical deformation process per-
formedbelowtherecrystallizationtemperaturewhichresultsin
Analysis
strain hardening of the material.
3.1.3 lot, n—the total number of mill products produced
1
This specification is under the jurisdiction of ASTM Committee F04 on from the same melt heat under the same conditions at essen-
Medical and Surgical Materials and Devices and is the direct responsibility of
tially the same time.
Subcommittee F04.12 on Metallurgical Materials.
3.1.4 hot work—any mechanical deformation process per-
Current edition approved Oct. 1, 2016. Published October 2016. Originally
approved in 1992. Last previous edition approved in 2011 as F1295–11. DOI:
formed above the recrystallization temperature.
10.1520/F1295-16.
2
The boldface numbers in parentheses refer to a list of references at the end of
the text.
3 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or AvailablefromSAEInternational(SAE),400CommonwealthDr.,Warrendale,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM PA 15096-0001, http://www.sae.org.
5
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.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

---------------------- Page: 1 ----------------------
F1295−16
TABLE 1 Chemical Requirements
3.1.5 stress relief—thermal treatment that reduces the re-
sidual stresses in the material without affecting the mechanical Element Composition, %
properties. Aluminum 5.50 to 6.50
Niobium 6.50 to 7.50
Tantalum 0.50 max
4. Product Classification
Iron 0.25 max
Oxygen 0.20 max
4.1 Bar—Rounds, or flats, or other shapes from 0.188 in.
Carbon 0.08 max
(4.76 mm) to 4.0 in. (102 mm) in diameter or thi
...

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: F1295 − 11 F1295 − 16
Standard Specification for
Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical
1
Implant Applications (UNS R56700)
This standard is issued under the fixed designation F1295; 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 annealed, cold-worked, or
hot-worked titanium-6aluminum-7niobium alloy bar, wire, sheet, strip, and plate to be used in the manufacture of surgical implants
2
(1-4).
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 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
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
E290 Test Methods for Bend Testing of Material for Ductility
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
IEEE/ASTM SI 10 American National Standard for Use of the International System of unitsUnits (SI): The Modern Metric
System
4
2.2 Aerospace Material Specification:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 2630 Inspection, Ultrasonic Product Over 0.5 Inch (12.7 mm) Thick
AMS 2631 Ultrasonic Inspection--Titanium and Titanium Alloy Bar and Billet
5
2.3 ISO Standards:
ISO 5832–11 Implants for Surgery—Metallic Materials—Part 11: Wrought Titanium 6–Aluminum 7–Niobium Alloy
ISO 68926892–1 Metallic Materials—Tensile Testing—Part 1: Method of Test at Room Temperature
ISO 9001 Quality Management Systems—Requirements
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.
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 Nov. 15, 2011Oct. 1, 2016. Published December 2011October 2016. Originally approved in 1992. Last previous edition approved in 20052011
as F1295 – 05.F1295 – 11. DOI: 10.1520/F1295-11.10.1520/F1295-16.
2
The boldface numbers in parentheses refer to a list of references at the end of the text.
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.
4
Available from SAE International (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
5
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.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

---------------------- Page: 1 ----------------------
F1295 − 16
3.1.2 cold work—any mechanical deformation process performed below the recrystallization temperature which results in strain
hardening of the material.
3.1.3 lot, n—the total number of mill products produced from the same melt heat under the same conditions at essentially the
same time.
3.1.4 hot work—any mechanical deformation process performed above the recrystallization temperature.
3.1.
...