ASTM F136-08e1
(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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´1
Designation: F136 – 08
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications (UNS
1
R56401)
ThisstandardisissuedunderthefixeddesignationF136;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1
´ NOTE—Subsection 8.3.1 was editorially corrected in December 2008.
1. Scope* F981 Practice forAssessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
1.1 This specification covers the chemical, mechanical, and
Materials on Muscle and Bone
metallurgical requirements for wrought annealed titanium-
3
2.2 ISO Standards:
6aluminum-4vanadium ELI (extra low interstitial) alloy
ISO 6892 Metallic Materials Tensile Testing at Ambient
(R56401) to be used in the manufacture of surgical implants.
Temperature
1.2 The values stated in inch-pound units are to be regarded
ISO 9001 Quality Management Systems Requirements
as standard. The values given in parentheses are mathematical
2.3 ASQ Standard:
conversions to SI units that are provided for information only
ASQ C1 Specifications of General Requirements for a
and are not considered standard.
4
Quality Control Program
2. Referenced Documents
2.4 Aerospace Material Specifications:
2
AMS 2249 Chemical Check Analysis Limits, Titanium and
2.1 ASTM Standards:
5
Titanium Alloys
E8/E8M Test Methods for Tension Testing of Metallic
Materials
3. Terminology
E29 Practice for Using Significant Digits in Test Data to
3.1 Definitions of Terms Specific to This Standard:
Determine Conformance with Specifications
3.1.1 beta transus, n—the minimum temperature at which
E290 Test Methods for Bend Testing of Material for Duc-
the alpha plus beta phase can transform to 100 % beta phase.
tility
3.1.2 lot, n—the total number of mill products produced
E539 Test Method for X-Ray Fluorescence Spectrometric
fromoneheatunderthesameconditionsatessentiallythesame
Analysis of 6Al-4V Titanium Alloy
time.
E1409 Test Method for Determination of Oxygen and
Nitrogen inTitanium andTitaniumAlloys by the Inert Gas
4. Product Classification
Fusion Technique
4.1 Strip—Any product under 0.1875 in. (4.76 mm) in
E1447 Test Method for Determination of Hydrogen in
thickness and under 24 in. (610 mm) wide.
Titanium and Titanium Alloys by Inert Gas Fusion Ther-
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in
mal Conductivity/Infrared Detection Method
thickness and 24 in. (610 mm) or more in width.
E1941 Test Method for Determination of Carbon in Refrac-
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and
tory and Reactive Metals and Their Alloys
over and 10 in. (254 mm) wide and over, with widths greater
E2371 Test Method for Analysis of Titanium and Titanium
than five times thickness. Plate up to 4.00 in. (101.60 mm),
Alloys by Atomic Emission Plasma Spectrometry
thick inclusive is covered by this specification.
4.4 Bar—Roundbarsandflatsfrom0.1875in.(4.76mm)to
4.00 in. (101.60 mm) in diameter or thickness (other sizes and
1
This specification is under the jurisdiction of ASTM Committee F04 on
shapes by special order).
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Nov. 1, 2008. Published December 2008. Originally
3
published in 1984. Last previous edition approved in 2002 as F136 – 02a. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F0136-08E01. 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 ----------------------
´1
F136 – 08
4.5 Forging Bar—Bar as described in 4.4, used for produc- reportingallchemicalrequirements,excepthydrogen.Samples
tion of forgings, may be furnished in the hot worked condition. for hydrogen shall be taken from the finished mill product.The
4.6 Wire—Rounds,flats,orothershapeslessthan0.1875in. supplier shall not ship material with chemistry outside the
(4.76 mm)
...
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.
´1
Designation:F136–08 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
´ NOTE—Subsection 8.3.1 was editorially corrected in December 2008.
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.
1.2 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 for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E 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 1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys 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:
4
ASQ C1 Specifications of General Requirements for a Quality Control Program
2.4 Aerospace Material Specifications:
5
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
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.
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. 1, 2008. Published December 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
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
5
Available from Society of Automotive Engineers (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 ----------------------
´1
F136–08
4. Product Classification
4.1 Strip—Any product under 0.1875 in. (4.76 mm) in thickness and under 24 in. (610 mm) wide.
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in thickness and 24 in. (610 mm) or more in width.
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and over and 10 in. (254 mm) wide and over, with widths greater than five
times thickness. Plate up to 4.00 in. (101.60 mm), thick inclusive is covered by this specification.
4.4 Bar—Round bars and flats from 0.1875 in. (4.76 mm) to 4.00 in. (101.60 mm) in diameter or thickness (other sizes and
shapes by special order).
4.5 Forging Bar—Bar as described in 4.4,
...
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.
´1
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
´ NOTE—Subsection 8.3.1 was editorially corrected in December 2008.
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 1447 Test 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 in Titanium and TitaniumAlloys 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
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 ----------------------
´1
F136–08
AMS 4930Titanium Alloy Bars, Forgings, and Rings 6AL-4V Extra Low Interstitial Annealed
2.4 Society of Automotive Engineers Standard:
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 th
...
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