ASTM F1295-24
(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.
General Information
- Status
- Published
- Publication Date
- 14-Mar-2024
- Technical Committee
- F04 - Medical and Surgical Materials and Devices
- Drafting Committee
- F04.12 - Metallurgical Materials
Relations
- Effective Date
- 15-Mar-2024
- Effective Date
- 15-Mar-2024
- Effective Date
- 15-Mar-2024
- Effective Date
- 15-Mar-2024
- Effective Date
- 15-Mar-2024
- Effective Date
- 15-Mar-2024
Overview
ASTM F1295-24: Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) sets forth the critical chemical, mechanical, and metallurgical requirements for titanium alloy materials intended for use in surgical implants. This internationally recognized specification covers various wrought mill product forms-including bar, wire, sheet, strip, and plate-in annealed, cold-worked, or hot-worked conditions. The standard ensures that materials used in orthopedic and medical device manufacturing are consistent, reliable, and suitable for surgical applications by outlining composition limits, manufacturing processes, and product properties.
Key Topics
- Alloy Composition: Specifies the acceptable chemical composition, including limits on aluminum, niobium, tantalum, iron, oxygen, carbon, nitrogen, hydrogen, and intentional restrictions on elements such as cobalt, ensuring biocompatibility and mechanical performance.
- Product Forms: Applicable to titanium-6aluminum-7niobium alloy (UNS R56700) in bar, wire, sheet, strip, and plate, furnished in various finishes and supplied in lengths and packaging as needed for medical manufacturing.
- Manufacture and Processing: Details that the alloy must be wrought and may be formed by forging, rolling, and related conventional techniques, with optional finishes such as descaled, pickled, sandblasted, ground, machined, peeled, or polished, and processed in arc furnaces like plasma arc and electron beam.
- Mechanical Properties: Outlines minimum values for tensile strength, yield strength, and ductility (elongation), ensuring surgical implants made from this alloy maintain high strength and resistance to deformation under physiological loads.
- Microstructure Requirements: Requires a fine dispersion of alpha and beta phases; prohibits continuous alpha network and coarse, elongated alpha platelets, supporting optimal implant performance.
- Testing & Inspection: Mandates tension and bend testing per referenced methods, ultrasonic inspection for flaw detection in larger sections, and rigorous chemical analysis for quality assurance.
- Quality and Certification: Requires suppliers to maintain ISO 9001 or ISO 13485-compliant quality management systems, certifying that materials meet all requirements at the time of shipment.
Applications
ASTM F1295-24 is widely used in the medical and orthopedic industry for:
- Surgical Implants: The specified titanium-6aluminum-7niobium alloy is used for fabricating critical load-bearing implants such as hip and knee prostheses, bone plates, screws, rods, and other internal fixation devices.
- Orthopedic Medical Devices: Suitable for parts exposed to soft tissue and bone, ensuring durability and biocompatibility.
- Custom Implant Manufacturing: Provides a foundation for custom and anatomically tailored implants where precise mechanical properties and strict material consistency are essential.
- Research and Development: Used as a reference standard in the development of innovative biomaterials and tissue-compatible medical devices.
Benefits of this standard include:
- Enhanced Biocompatibility: The alloy has a long clinical history of safe use with minimal adverse tissue reactions.
- Performance Reliability: Controls on composition, microstructure, and properties promote longevity and load-resistance in implants.
- Regulatory Conformity: Compliance with global medical device regulations, including reference to ISO standards, supports international market access.
Related Standards
ASTM F1295-24 references several important standards to ensure comprehensive material evaluation, including:
- ASTM B367: Specification for Titanium and Titanium Alloy Castings
- ASTM E8/E8M: Test Methods for Tension Testing of Metallic Materials
- ASTM E290: Test Methods for Bend Testing of Material for Ductility
- ASTM E539, E1409, E1447, E1941, E2371, E2994: Methods for chemical analysis of titanium alloys
- AMS 2249, AMS 2630, AMS 2631: Aerospace material standards for chemical analysis and ultrasonic inspection
- ISO 5832-11: Wrought Titanium 6-Aluminum 7-Niobium Alloy for Surgical Implants
- ISO 9001/ISO 13485: Quality management systems for general and medical device manufacturing
Organizations and manufacturers using this standard are encouraged to reference these related documents for complete compliance and up-to-date best practices in surgical implant material selection and testing.
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Frequently Asked Questions
ASTM F1295-24 is a technical specification published by ASTM International. Its full title is "Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)". This standard covers: 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.
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.
ASTM F1295-24 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F1295-24 has the following relationships with other standards: It is inter standard links to ASTM F1295-23, ASTM F2193-20, ASTM F2180-17, ASTM F384-17, ASTM F543-23, ASTM F620-20. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F1295-24 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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 − 24
Standard Specification for
Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical
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
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
This specification is under the jurisdiction of ASTM Committee F04 on
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 March 15, 2024. Published April 2024. Originally
Part 11: Wrought Titanium 6-Aluminum 7-Niobium Alloy
approved in 1992. Last previous edition approved in 2023 as F1295 – 23. DOI:
10.1520/F1295-24.
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.
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
F1295 − 24
ISO 6892-1 Metallic Materials—Tensile Testing—Part 1: 6. Materials and Manufacture
Method of Test at Room Temperature
6.1 Finish—The mill product may be supplied as specified
ISO 9001 Quality Management Systems—Requirements
by the purchaser with a descaled or pickled, abrasive-blasted,
ISO 13485 Medical Devices—Quality Management
chemically milled, ground, machined, peeled, or polished
Systems—Requirements for Regulatory Purposes
finish.
6.2 Condition—Material shall be furnished in the annealed,
3. Terminology
cold-worked, or hot-worked condition. The purchaser shall
3.1 Definitions of Terms Specific to This Standard:
include on drawings or purchase orders whether the material
3.1.1 beta transus, n—the minimum temperature at which
shall be stress-relieved.
the alpha-plus-beta phase can transform to 100 % beta phase.
7. Chemical Requirements
3.1.2 cold work—any mechanical deformation process per-
formed below the recrystallization temperature which results in
7.1 The supplier’s heat analysis shall conform to the chemi-
strain hardening of the material.
cal composition of Table 1. The supplier shall not ship material
with chemistry outside the requirements specified in Table 1.
3.1.3 hot work—any mechanical deformation process per-
Ingot analysis may be used for reporting all chemical
formed above the recrystallization temperature.
requirements, except hydrogen. Samples for hydrogen shall be
3.1.4 lot, n—the total number of mill products produced
taken from the finished mill product.
from the same melt heat under the same conditions at essen-
7.1.1 Requirements for the major and minor elemental
tially the same time.
constituents are listed in Table 1. Also listed are important
3.1.5 stress relief—thermal treatment that reduces the re-
residual elements.
sidual stresses in the material without affecting the mechanical
7.1.2 All commercial metals may contain small amounts of
properties.
elements other than those which are specified in Table 1. It is
neither practical nor necessary to specify limits for unspecified
4. Product Classification
elements that can be present. The producer is permitted to
analyze for unspecified elements and is permitted to report
4.1 Bar—Round, rectangular, or other complex shaped
such analyses. The presence of an unspecified element and the
product delivered straightened and cut to defined lengths.
reporting of an analysis for that element shall not be a basis for
4.2 Forging Bar—Bar as described in 4.1, used in the
rejection unless previously agreed to between purchaser and
production of forgings. This product may be furnished in the
supplier.
hot-worked condition.
7.1.3 Intentional elemental additions other than those speci-
4.3 Wire—Round, rectangular, or other complex shapes of
fied in Table 1 are not permitted.
uniform cross section along its entire length furnished in coils, 7.1.4 Analysis for elements not listed in Table 1 is not
or on spools, reels, or other packaging as specified.
required to certify compliance with this specification.
7.1.5 Methods and practices relating to chemical analysis
4.4 Strip—Any product 4.76 mm [0.188 in.] and under in
required by this specification shall be tested in accordance with
thickness and less than 610 mm [24 in.] in width.
Test Methods E539, E1409, E1447, E1941, E2371, and E2994,
4.5 Sheet—Any product 4.76 mm [0.188 in.] and under in
and Guide E2626.
thickness and 610 mm [24 in.] or more in width.
4.6 Plate—Any product 4.76 mm [0.188 in.] thick and over
TABLE 1 Chemical Requirements
254 mm [10 in.] wide and over, with widths greater than five
Element Composition, %
times thickness. Plate up to 101.60 mm [4 in.] thick, inclusive,
Aluminum 5.50 to 6.50
is covered by this specification.
Niobium 6.50 to 7.50
Tantalum 0.50 max
5. Ordering Information
Iron 0.25 max
Oxygen 0.20 max
5.1 Include with inquiries and orders for material under this
Carbon 0.08 max
Nitrogen 0.05 max
specification the following information:
Hydrogen 0.009 max
5.1.1 Quantity (weight or number of pieces),
Cobalt <0.10
A
5.1.2 Applicable ASTM designation, date of issue,
Other elements each 0.10 max
Other elements total 0.4 max
5.1.3 Form (bar, wire, sheet, strip, or plate),
B
Titanium Balance
5.1.4 Condition (see 6.2),
A
Other elements need not be reported unless the concentration level is greater
5.1.5 Mechanical properties (if applicable for special
than 0.1 % each, or 0.4 % total. Other elements may not be added intentionally.
conditions), Other elements may be present in titanium or titanium alloys in small quantities
and are inherent to the manufacturing process. In titanium these elements typically
5.1.6 Finish (see 6.1),
include aluminum, vanadium, tin, chromium, molybdenum, niobium, zirconium,
5.1.7 Applicable dimensions including size, thickness,
hafnium, bismuth, ruthenium, palladium, yttrium, copper, silicon, cobalt, tantalum,
nickel, boron, manganese, and tungsten.
width, or drawing number,
B
The percentage of titanium is determined by difference and need not be
5.1.8 Special tests, if any, and
determined or certified.
5.1.9 Other requirements.
F1295 − 24
7.2 Product (Check) Analysis—The product (check) analy- 8.2 Specimens for tension tests shall be machined and tested
sis tolerances shall conform to the product tolerances in Table in accordance with Test Methods E8/E8M. Tensile properties
2 per AMS 2249. Product (check) analysis tolerances do not shall be determined using a strain rate of 0.003 to 0.007
broaden the specified heat (ladle or ingot) analysis require- mm/mm/min [in./in./min] through the specified yield and then
ments but cover variations between laboratories in the mea- the crosshead speed shall be increased so as to produce fracture
surement of chemical content. in approximately one additional minute.
7.2.1 Product (check) analysis limits are not for producer’s 8.2.1 Bar, Forging Bar, and Wire—Test according to Test
use at supplier’s/producer’s acceptance testing. Product analy- Methods E8/E8M.
sis tolerances are not permitted to be applied to ladle or ingot 8.2.2 Tensile tests result for which any specimen fractures
analysis. The supplier shall not ship material that is outside the outside the gauge length shall be considered valid if both the
limits specified in Table 1. elongation and reduction of area meet the minimum require-
7.2.2 A product (check) analysis is one performed by the ments specified and all other results conform to Table 3. If
purchaser or supplier of the metal after it has been worked into either the elongation or reduction of area is less than the
one of the forms specified in Section 4, and is either for the minimum requirement, discard the test and retest. Retest one
purpose of verifying the composition of a heat or manufactur- specimen for each invalidated specimen.
ing lot or to determine variations in the composition within the
8.2.3 Should any test specimen not meet the specified
heat. requirements, test two additional test pieces representative of
7.2.3 Acceptance or rejection of a heat or manufacturing lot
the same lot, in the same manner, for each failed test specimen.
of material may be made by the purchaser on the basis of this The lot will be considered in compliance only if all additional
product (check) analysis. Product (check) analysis outside the
test pieces meet the specified requirements.
tolerance limits allowed in Table 2 are cause for rejection of the
8.3 Sheet, Strip, and Plate:
product. A referee analysis may be used if agreed by supplier
8.3.1 Test according to Test Methods E8/E8M. Perform at
and purchaser.
least one tensile test from each lot in both the longitudinal and
7.3 For referee purposes, use Test Methods E539, E1409,
transverse directions. Tests in the transverse direction need be
E1447, E1941, E2371, and E2994, and Guide E2626 or other made only on product from which a specimen not less than
analytical methods agreed upon between the purchaser and the
200 mm [8.0 in.] in length for strip can be taken. Should any of
supplier. these test specimens not meet the specified requirements, test
two additional test pieces representative of the same lot, in the
7.4 Samples for chemical analysis shall be representative of
same manner, for each failed test specimen. The lot will be
the material being tested. The
...
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 − 23 F1295 − 24
Standard Specification for
Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical
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
(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
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)
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 April 1, 2023March 15, 2024. Published April 2023April 2024. Originally approved in 1992. Last previous edition approved in 20222023 as
F1295 – 22.F1295 – 23. DOI: 10.1520/F1295-23.10.1520/F1295-24.
The boldface numbers in parentheses refer to a list of references at the end of the text.
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
F1295 − 24
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
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
2.3 ISO Standards:
ISO 5832-11 Implants for Surgery—Metallic Materials—Part 11: Wrought Titanium 6-Aluminum 7-Niobium Alloy
ISO 6892-1 Metallic Materials—Tensile Testing—Part 1: Method of Test at Room Temperature
ISO 9001 Quality Management Systems—Requirements
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
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 cold work—any mechanical deformation process performed below the recrystallization temperature which results in strain
hardening of the material.
3.1.3 hot work—any mechanical deformation process performed above the recrystallization temperature.
3.1.4 lot, n—the total number of mill products produced from the same melt heat under the same conditions at essentially the same
time.
3.1.5 stress relief—thermal treatment that reduces the residual stresses in the material without affecting the mechanical properties.
4. Product Classification
4.1 Bar—Round, rectangular, or other complex shaped product delivered straightened and cut to defined lengths.
4.2 Forging Bar—Bar as described in 4.1, used in the production of forgings. This product may be furnished in the hot-worked
condition.
4.3 Wire—Round, rectangular, or other complex shapes of uniform cross section along its entire length furnished in coils, or on
spools, reels, or other packaging as specified.
4.4 Strip—Any product 4.76 mm [0.188 in.] and under in thickness and less than 610 mm [24 in.] in width.
4.5 Sheet—Any product 4.76 mm [0.188 in.] and under in thickness and 610 mm [24 in.] or more in width.
4.6 Plate—Any product 4.76 mm [0.188 in.] thick and over 254 mm [10 in.] wide and over, with widths greater than five times
thickness. Plate up to 101.60 mm [4 in.] thick, inclusive, is covered by this specification.
5. Ordering Information
5.1 Include with inquiries and orders for material under this specification the following information:
5.1.1 Quantity (weight or number of pieces),
The last approved version of this historical standard is referenced on www.astm.org.
Available from SAE International (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
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5.1.2 Applicable ASTM designation, date of issue,
5.1.3 Form (bar, wire, sheet, strip, or plate),
5.1.4 Condition (see 6.2),
5.1.5 Mechanical properties (if applicable for special conditions),
5.1.6 Finish (see 6.1),
5.1.7 Applicable dimensions including size, thickness, width, or drawing number,
5.1.8 Special tests, if any, and
5.1.9 Other requirements.
6. Materials and Manufacture
6.1 Finish—The mill product may be supplied as specified by the purchaser with a descaled or pickled, abrasive-blasted,
chemically milled, ground, machined, peeled, or polished finish.
6.2 Condition—Material shall be furnished in the annealed, cold-worked, or hot-worked condition. The purchaser shall include on
drawings or purchase orders whether the material shall be stress-relieved.
7. Chemical Requirements
7.1 The supplier’s heat analysis shall conform to the chemical composition of Table 1. The supplier shall not ship material with
chemistry outside the requirements specified in Table 1. Ingot analysis may be used for reporting all chemical requirements, except
hydrogen. Samples for hydrogen shall be taken from the finished mill product.
7.1.1 Requirements for the major and minor elemental constituents are listed in Table 1. Also listed are important residual
elements.
TABLE 1 Chemical Requirements
Element Composition, %
Aluminum 5.50 to 6.50
Niobium 6.50 to 7.50
Tantalum 0.50 max
Iron 0.25 max
Oxygen 0.20 max
Carbon 0.08 max
Nitrogen 0.05 max
Hydrogen 0.009 max
A
Cobalt <0.10
Cobalt <0.10
B
Other elements each 0.10 max
A
Other elements each 0.10 max
Other elements total 0.4 max
C
Titanium Balance
B
Titanium Balance
A
Refer to X1.8.
A
Other elements need not be reported unless the concentration level is greater
than 0.1 % each, or 0.4 % total. Other elements may not be added intentionally.
Other elements may be present in titanium or titanium alloys in small quantities
and are inherent to the manufacturing process. In titanium these elements typically
include aluminum, vanadium, tin, chromium, molybdenum, niobium, zirconium,
hafnium, bismuth, ruthenium, palladium, yttrium, copper, silicon, cobalt, tantalum,
nickel, boron, manganese, and tungsten.
B
The percentage of titanium is determined by difference and need not be
determined or certified.
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7.1.2 All commercial metals may contain small amounts of elements other than those which are specified in Table 1. It is neither
practical nor necessary to specify limits for unspecified elements that can be present. The producer is permitted to analyze for
unspecified elements and is permitted to report such analyses. The presence of an unspecified element and the reporting of an
analysis for that element shall not be a basis for rejection unless previously agreed to between purchaser and supplier.
7.1.3 Intentional elemental additions other than those specified in Table 1 are not permitted.
7.1.4 Analysis for elements not listed in Table 1 is not required to certify compliance with this specification.
7.1.5 Methods and practices relating to chemical analysis required by this specification shall be tested in accordance with Test
Methods E539, E1409, E1447, E1941, E2371, and E2994, and Guide E2626.
7.2 Product (Check) Analysis—The product (check) analysis tolerances shall conform to the product tolerances in Table 2 per
AMS 2249. Product (check) analysis tolerances do not broaden the specified heat (ladle or ingot) analysis requirements but cover
variations between laboratories in the measurement of chemical content.
7.2.1 Product (check) analysis limits are not for producer’s use at supplier’s/producer’s acceptance testing. Product analysis
tolerances are not permitted to be applied to ladle or ingot analysis. The supplier shall not ship material that is outside the limits
specified in Table 1.
7.2.2 A product (check) analysis is one performed by the purchaser or supplier of the metal after it has been worked into one of
the forms specified in Section 4, and is either for the purpose of verifying the composition of a heat or manufacturing lot or to
determine variations in the composition within the heat.
7.2.3 Acceptance or rejection of a heat or manufacturing lot of material may be made by the purchaser on the basis of this product
(check) analysis. Product (check) analysis outside the tolerance limits allowed in Table 2 are cause for rejection of the product.
A referee analysis may be used if agreed by supplier and purchaser.
7.3 For referee purposes, use Test Methods E539, E1409, E1447, E1941, E2371, and E2994, and Guide E2626 or other analytical
methods agreed upon between the purchaser and the supplier.
7.4 Samples for chemical analysis shall be representative of the material being tested. The utmost care must be used in sampling
titanium for chemical analysis because of its ability to react with elements such as oxygen, nitrogen, and hydrogen. In cutting
samples for analysis, therefore, the operation should be carried out insofar as possible in a dust-free atmosphere. Cutting tools
should be clean and sharp. Samples for analysis should be stored in suitable containers.
8. Mechanical Requirements
8.1 The material supplied under this specification shall conform to the mechanical properties given in Table 3. Alternative
properties may be agreed upon between the purchaser and supplier.
A
TABLE 2 Product Analysis Tolerances
B
Tolerance Under the Minimum or Over the Maximum Limit (%)
Aluminum 0.40
Niobium 0.20 under min
0.25 over max
Tantalum 0.10
Iron 0.10
Oxygen 0.02
Carbon 0.02
Nitrogen 0.02
Hydrogen 0.002
C
Cobalt 0.02
A
Refer to AMS 2249.
B
Under minimum limit not applicable for elements where only a maximum
percentage is indicated.
C
Refer to Specification B367, Table 2 “Other (Each).”
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TABLE 3 Mechanical Properties for Bar and Wire
B
Ultimate Tensile Strength, Yield Strength (0.2 % Reduction of Area,
A Elongation,
Condition
min, MPa [psi] Offset), min, MPa [psi] min, % min, %
Annealed 900 [130 500] 800 [116 000] 10 25
Hot Worked 900 [130 500] 800 [116 000] 10 25
Cold Worked 1100 [159 500] 800 [116 000] 10 25
A
Mechanical properties for conditions other than those listed in this table may be established by agreement between the supplier and purchaser.
B
Elongation of material 1.6 mm [0.063 in.] or greater in diameter (D) or thickness (T) shall be measured using a gauge length of 50 mm [2 in.] or 4D or 4W. The gauge
length must be reported with the test results. The method for determining elongation of material under 1.6 mm [0.063 in.] in diameter or thickness may be negotiated.
Alternatively, a gauge length of 5.65 times the square root of So, where So is the original cross-sectional area corresponding to ISO 6892-1, may be used when agreed
upon between supplier and purchaser.
8.2 Specimens for tension tests shall be machined and test
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