ASTM F1295-11
(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 titanium-6 aluminum-7 niobium alloy bar and wire to be used in the manufacture of surgical implants (1-4).
1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents in parentheses are for information only.
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Designation:F1295 −11
StandardSpecification 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* Plasma Atomic Emission Spectrometry (Performance-
Based Test Methodology)
1.1 This specification covers the chemical, mechanical, and
E2626Guide for Spectrometric Analysis of Reactive and
metallurgicalrequirementsforwroughtannealed,cold-worked,
Refractory Metals
or hot-worked titanium-6aluminum-7niobium alloy bar, wire,
SI 10American National Standard for Use of the Interna-
sheet, strip, and plate to be used in the manufacture of surgical
2 tional System of units (SI): The Modern Metric System
implants (1-4).
4
2.2 Aerospace Material Specification:
1.2 The values stated in either SI units or inch-pound units
AMS 2249Chemical Check Analysis Limits, Titanium and
are to be regarded separately as standard. The values stated in
Titanium Alloys
each system may not be exact equivalents; therefore, each
AMS 2630Inspection, Ultrasonic Product Over 0.5 Inch
system shall be used independently of the other. Combining
(12.7 mm) Thick
values from the two systems may result in non-conformance
AMS 2631Ultrasonic Inspection--Titanium and Titanium
with the standard.
Alloy Bar and Billet
5
2. Referenced Documents 2.3 ISO Standards:
3 ISO 5832–11Implants for Surgery—Metallic Materials—
2.1 ASTM Standards:
Part 11: Wrought Titanium 6–Aluminum 7–Niobium Al-
E8/E8MTest Methods for Tension Testing of Metallic Ma-
loy
terials
ISO 6892 Metallic Materials—Tensile Testing—Part 1:
E29Practice for Using Significant Digits in Test Data to
Method of Test at Room Temperature
Determine Conformance with Specifications
ISO 9001Quality Management Systems—Requirements
E290Test Methods for Bend Testing of Material for Ductil-
ity
3. Terminology
E1409TestMethodforDeterminationofOxygenandNitro-
3.1 Definitions of Terms Specific to This Standard:
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
3.1.1 beta transus, n—the minimum temperature at which
E1447Test Method for Determination of Hydrogen in Tita-
the alpha plus beta phase can transform to 100% beta phase.
nium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
3.1.2 cold work—any mechanical deformation process per-
E1941Test Method for Determination of Carbon in Refrac-
formedbelowtherecrystallizationtemperaturewhichresultsin
toryandReactiveMetalsandTheirAlloysbyCombustion
strain hardening of the material.
Analysis
3.1.3 lot, n—the total number of mill products produced
E2371Test Method for Analysis of Titanium and Titanium
from the same melt heat under the same conditions at essen-
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
tially the same time.
3.1.4 hot work—any mechanical deformation process per-
1
This specification is under the jurisdiction of ASTM Committee F04 on
formed above the recrystallization temperature.
Medical and Surgical Materials and Devices and is the direct responsibility of
3.1.5 stress relief—thermal treatment that reduces the re-
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Nov. 15, 2011. Published December 2011. Originally sidual stresses in the material without affecting the mechanical
approved in 1992. Last previous edition approved in 2005 as F1295–05. DOI:
properties.
10.1520/F1295-11.
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 service@astm.org. 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 ----------------------
F1295−11
TABLE 1 Chemical Requirements
4. Product Classification
Element Composition, %
4.1 Bar—Rounds, or flats, or other shapes from 0.188 in.
Aluminum 5.50 to 6.50
(4.76 mm) to 4.0 in. (102 mm) in diameter or thickness. Other
Niobium 6.50 to 7.50
sizes and shapes by special order.
Tantalum 0.50 max
Iron 0.25 max
4.2 Forging Bar—Bar as described in 4.1, used i
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F1295–05 Designation: F1295 – 11
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 rolled hot-worked titanium-6aluminum-7niobium alloy bar, wire, sheet, strip, and wireplate to be used in the manufacture of
2
surgical implants (1-4).
1.2Thevaluesstatedininch-poundunitsaretoberegardedasthestandard.TheSIequivalentsinparenthesesareforinformation
only.
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 from the
two systems may result in non-conformance with the standard.
2. Referenced Documents
3
2.1 ASTM Standards:
E88/E8M Test Methods for Tension Testing of Metallic Materials
E120TestMethodsforChemicalAnalysisofTitaniumandTitaniumAlloys29 PracticeforUsingSignificantDigitsinTestData
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 the Inert Gas Fusion
Technique
E1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
F981Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
E1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and TheirAlloys by CombustionAnalysis
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Atomic Emission Plasma Spectrometry
E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals
SI 10 American National Standard for Use of the International System of units (SI): The Modern Metric System
2.2 ISO Standards:
ISO5832–11Implants for Surgery—Metallic Materials—Part 11: Wrought Titanium 6–Aluminum 7–Niobium Alloy
ISO 6892 Metallic Materials—Tensile Testing
4
2.3 Aerospace Material Specification:
AMS 2249Chemical Check Analysis Limits, Titanium and Titanium Alloys
2.4 American Society for Quality Standard:
ASQC1Specification of General Requirements for a Quality Program Chemical CheckAnalysis Limits,Titanium andTitanium
Alloys
AMS 2630 Inspection, Ultrasonic Product Over 0.5 Inch (12.7 mm) Thick
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 Jan. 1, 2005. Published January 2005. Originally approved in 1992. Last previous edition approved in 2001 as F1295–01. DOI:
10.1520/F1295-05.
Current edition approved Nov. 15, 2011. Published December 2011. Originally approved in 1992. Last previous edition approved in 2005 as F1295 – 05. DOI:
10.1520/F1295-11.
2
The boldface numbers in parentheses refer to a list of references at the end of the text.
3
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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.
4
Available from SAE International (SAE), 400 Commonwealth Dr., Warrendale, 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
---------------------- Page: 1 ----------------------
F1295 – 11
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 6892 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 minim
...
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