ASTM F1295-23
(Specification)Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
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 (1-7).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 nonconformance with 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.
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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: F1295 − 23
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* E29 Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
1.1 This specification covers the chemical, mechanical, and
E290 Test Methods for Bend Testing of Material for Ductil-
metallurgical requirements for wrought annealed, cold-worked,
ity
or hot-worked titanium-6aluminum-7niobium alloy bar, wire,
E539 Test Method for Analysis of Titanium Alloys by
sheet, strip, and plate to be used in the manufacture of surgical
2 Wavelength Dispersive X-Ray Fluorescence Spectrometry
implants (1-7).
E1409 Test Method for Determination of Oxygen and Nitro-
1.2 The SI units in this standard are the primary units. The
gen in Titanium and Titanium Alloys by Inert Gas Fusion
values stated in either primary SI units or secondary inch-
E1447 Test Method for Determination of Hydrogen in Re-
pound units are to be regarded separately as standard. The
active Metals and Reactive Metal Alloys by Inert Gas
values stated in each system may not be exact equivalents;
Fusion with Detection by Thermal Conductivity or Infra-
therefore, each system shall be used independently of the other.
red Spectrometry
Combining values from the two systems may result in noncon-
E1941 Test Method for Determination of Carbon in Refrac-
formance with the standard.
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- E2626 Guide for Spectrometric Analysis of Reactive and
4
dance with internationally recognized principles on standard-
Refractory Metals (Withdrawn 2017)
ization established in the Decision on Principles for the
E2994 Test Method for Analysis of Titanium and Titanium
Development of International Standards, Guides and Recom- Alloys by Spark Atomic Emission Spectrometry and Glow
mendations issued by the World Trade Organization Technical
Discharge Atomic Emission Spectrometry (Performance-
Barriers to Trade (TBT) Committee. Based Method)
IEEE/ASTM SI 10 American National Standard for Metric
2. Referenced Documents
Practice
3 5
2.1 ASTM Standards: 2.2 Aerospace Material Specification:
B367 Specification for Titanium and Titanium Alloy Cast- AMS 2249 Chemical Check Analysis Limits, Titanium and
ings Titanium Alloys
E8/E8M Test Methods for Tension Testing of Metallic Ma- AMS 2630 Inspection, Ultrasonic Product Over 0.5 Inch
terials (12.7 mm) Thick
AMS 2631 Ultrasonic Inspection—Titanium and Titanium
Alloy Bar and Billet
1
This specification is under the jurisdiction of ASTM Committee F04 on
6
2.3 ISO Standards:
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
ISO 5832-11 Implants for Surgery—Metallic Materials—
Current edition approved April 1, 2023. Published April 2023. Originally
Part 11: Wrought Titanium 6-Aluminum 7-Niobium Alloy
approved in 1992. Last previous edition approved in 2022 as F1295 – 22. DOI:
10.1520/F1295-23.
2 4
The boldface numbers in parentheses refer to a list of references at the end of The last approved version of this historical standard is referenced on
the text. www.astm.org.
3 5
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from SAE International (SAE), 400 Commonwealth Dr., Warrendale,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM PA 15096-0001, http://www.sae.org.
6
Standards volume information, refer to the standard’s Document Summary page on Available from American 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 Internati
...
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 − 22 F1295 − 23
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
(1-7).
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 nonconformance with 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
3
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 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 Nov. 15, 2022April 1, 2023. Published November 2022April 2023. Originally approved in 1992. Last previous edition approved in 20162022
as F1295 – 16.F1295 – 22. DOI: 10.1520/F1295-22.10.1520/F1295-23.
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 service@astm.org. 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 ----------------------
F1295 − 23
4
E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals (Withdrawn 2017)
E2994 Test Method for Analysis of Titanium and Titanium Alloys by Spark Atomic Emission Spectrometry and Glow Discharge
Atomic Emission Spectrometry (Performance-Based Method)
IEEE/ASTM SI 10 American National Standard for Metric Practice
5
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
6
2.3 ISO Standards:
ISO 5832-11 Implants for Surgery—Metallic Materials—Part 11: Wrought Titanium 6-Aluminum 7-Niobium Alloy
ISO 689
...
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 − 23
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* E29 Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
1.1 This specification covers the chemical, mechanical, and
E290 Test Methods for Bend Testing of Material for Ductil-
metallurgical requirements for wrought annealed, cold-worked,
ity
or hot-worked titanium-6aluminum-7niobium alloy bar, wire,
E539 Test Method for Analysis of Titanium Alloys by
sheet, strip, and plate to be used in the manufacture of surgical
2 Wavelength Dispersive X-Ray Fluorescence Spectrometry
implants (1-7).
E1409 Test Method for Determination of Oxygen and Nitro-
1.2 The SI units in this standard are the primary units. The
gen in Titanium and Titanium Alloys by Inert Gas Fusion
values stated in either primary SI units or secondary inch-
E1447 Test Method for Determination of Hydrogen in Re-
pound units are to be regarded separately as standard. The
active Metals and Reactive Metal Alloys by Inert Gas
values stated in each system may not be exact equivalents;
Fusion with Detection by Thermal Conductivity or Infra-
therefore, each system shall be used independently of the other.
red Spectrometry
Combining values from the two systems may result in noncon-
E1941 Test Method for Determination of Carbon in Refrac-
formance with the standard.
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-
E2626 Guide for Spectrometric Analysis of Reactive and
4
dance with internationally recognized principles on standard-
Refractory Metals (Withdrawn 2017)
ization established in the Decision on Principles for the E2994 Test Method for Analysis of Titanium and Titanium
Development of International Standards, Guides and Recom-
Alloys by Spark Atomic Emission Spectrometry and Glow
mendations issued by the World Trade Organization Technical Discharge Atomic Emission Spectrometry (Performance-
Barriers to Trade (TBT) Committee.
Based Method)
IEEE/ASTM SI 10 American National Standard for Metric
2. Referenced Documents
Practice
3 5
2.1 ASTM Standards: 2.2 Aerospace Material Specification:
B367 Specification for Titanium and Titanium Alloy Cast- AMS 2249 Chemical Check Analysis Limits, Titanium and
ings Titanium Alloys
E8/E8M Test Methods for Tension Testing of Metallic Ma- AMS 2630 Inspection, Ultrasonic Product Over 0.5 Inch
terials (12.7 mm) Thick
AMS 2631 Ultrasonic Inspection—Titanium and Titanium
Alloy Bar and Billet
1
This specification is under the jurisdiction of ASTM Committee F04 on
6
2.3 ISO Standards:
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
ISO 5832-11 Implants for Surgery—Metallic Materials—
Current edition approved April 1, 2023. Published April 2023. Originally
Part 11: Wrought Titanium 6-Aluminum 7-Niobium Alloy
approved in 1992. Last previous edition approved in 2022 as F1295 – 22. DOI:
10.1520/F1295-23.
2 4
The boldface numbers in parentheses refer to a list of references at the end of The last approved version of this historical standard is referenced on
the text. www.astm.org.
3 5
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from SAE International (SAE), 400 Commonwealth Dr., Warrendale,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM PA 15096-0001, http://www.sae.org.
6
Standards volume information, refer to the standard’s Document Summary page on Available from American 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 ----------------------
...
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