ASTM F136-08
(Specification)Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants. The products are classified into: strip, sheet, plate, bar, forging bar, and wire. The heat analysis shall conform to the chemical composition requirements specified. Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations between laboratories in the measurement of chemical content. Tension test and bend test shall be performed to meet the requirements specified.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants.
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
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Designation: F 136 – 08
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications (UNS
1
R56401)
This standard is issued under the fixed designation F 136; 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.
3
1. Scope* 2.2 ISO Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient
1.1 This specification covers the chemical, mechanical, and
Temperature
metallurgical requirements for wrought annealed titanium-
ISO 9001 Quality Management Systems Requirements
6aluminum-4vanadium ELI (extra low interstitial) alloy
2.3 ASQ Standard:
(R56401) to be used in the manufacture of surgical implants.
ASQ C1 Specifications of General Requirements for a
1.2 The values stated in inch-pound units are to be regarded
4
Quality Control Program
as standard. The values given in parentheses are mathematical
2.4 Aerospace Material Specifications:
conversions to SI units that are provided for information only
AMS 2249 Chemical Check Analysis Limits, Titanium and
and are not considered standard.
5
Titanium Alloys
2. Referenced Documents
3. Terminology
2
2.1 ASTM Standards:
3.1 Definitions of Terms Specific to This Standard:
E 8/E 8M Test Methods for Tension Testing of Metallic
3.1.1 beta transus, n—the minimum temperature at which
Materials
the alpha plus beta phase can transform to 100 % beta phase.
E29 Practice for Using Significant Digits in Test Data to
3.1.2 lot, n—the total number of mill products produced
Determine Conformance with Specifications
fromoneheatunderthesameconditionsatessentiallythesame
E 290 Test Methods for Bend Testing of Material for
time.
Ductility
E 539 Test Method for X-Ray Fluorescence Spectrometric
4. Product Classification
Analysis of 6Al-4V Titanium Alloy
4.1 Strip—Any product under 0.1875 in. (4.76 mm) in
E 1409 Test Method for Determination of Oxygen and
thickness and under 24 in. (610 mm) wide.
Nitrogen inTitanium andTitaniumAlloys by the Inert Gas
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in
Fusion Technique
thickness and 24 in. (610 mm) or more in width.
E 1447 Test Method for Determination of Hydrogen in
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and
Titanium and Titanium Alloys by the Inert Gas Fusion
over and 10 in. (254 mm) wide and over, with widths greater
Thermal Conductivity/Infrared Detection Method
than five times thickness. Plate up to 4.00 in. (101.60 mm),
E 1941 TestMethodforDeterminationofCarboninRefrac-
thick inclusive is covered by this specification.
tory and Reactive Metals and Their Alloys
4.4 Bar—Roundbarsandflatsfrom0.1875in.(4.76mm)to
E 2371 Test Method forAnalysis of Titanium and Titanium
4.00 in. (101.60 mm) in diameter or thickness (other sizes and
Alloys by Atomic Emission Plasma Spectrometry
shapes by special order).
F 981 Practice for Assessment of Compatibility of Bioma-
4.5 Forging Bar—Bar as described in 4.4, used for produc-
terials for Surgical Implants with Respect to Effect of
tion of forgings, may be furnished in the hot worked condition.
Materials on Muscle and Bone
4.6 Wire—Rounds,flats,orothershapeslessthan0.1875in.
(4.76 mm) in diameter.
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.
3
Current edition approved Nov. 1, 2008. Published December 2008. Originally Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
published in 1984. Last previous edition approved in 2002 as F 136 – 02a. 4th Floor, New York, NY 10036, http://www.ansi.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Milwaukee, WI 53203, http://www.asq.org.
5
Standards volume information, refer to the standard’s Document Summary page on Available from Society of Automotive Engineers (SAE), 400 Commonwealth
the ASTM website. 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 ----------------------
F136–08
5. Ordering Information 7.1.1 Requirements for the major and minor elemental
constituents are listed in Table 3. Also listed are important
5.1 Include with inquiries and orders for material under this
residual elements.Analysis for elements
...
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:F136–02a Designation: F 136 – 08
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications (UNS
1
R56401)
This standard is issued under the fixed designation F 136; 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 titanium-
6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants.
1.2The values stated in inch-pound units are to be regarded as the standard. The SI equivalents in parentheses are provided for
information only.
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
2. Referenced Documents
2
2.1 ASTM Standards:
E 8/E 8M Test Methods offor Tension Testing of Metallic Materials
E120Test Methods for Chemical Analysis of Titanium and Titanium Alloys
3
E290Test Method for Bend Testing of Materials for Ductility
29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E527Practice for Numbering Metals and Alloys (UNS) 290 Test Methods for Bend Testing of Material for Ductility
E 539 Test Method for X-Ray Fluorescence Spectrometric Analysis of 6Al-4V Titanium Alloy
E 1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by the Inert Gas Fusion
Technique
E 1447Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Thermal
3
Conductivity Method Test Method for Determination of Hydrogen inTitanium andTitaniumAlloys by the Inert Gas Fusion
Thermal Conductivity/Infrared Detection Method
E 1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys
E 2371 Test Method for Analysis of Titanium and Titanium Alloys by Atomic Emission Plasma Spectrometry
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
3
2.2 ISO Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems Requirements
2.3 ASQ Standard:
ASQ C1 Specifications of General Requirements for a Quality Control Program
4
2.3
2.4 Aerospace Material Specifications:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 4930Titanium Alloy Bars, Forgings, and Rings 6AL-4V Extra Low Interstitial Annealed
2.4 Society of Automotive Engineers Standard:
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. 10, 2002.1, 2008. Published December 2002.2008. Originally published in 1984. Last previous edition approved in 2002 as F 136 – 02a.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 03.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Annual Book of ASTM Standards, Vol 03.05.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Annual Book of ASTM Standards, Vol 01.01.
4
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.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 ----------------------
F136–08
5
SAE J1086Practice 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 under the same conditions at essentially the same time.
4. Product Classification
4.1 Strip—Any product under 0.1875 in. (4
...
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