ASTM F136-12a
(Specification)Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium 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:F136 −12a
StandardSpecification for
Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications (UNS
1
R56401)
ThisstandardisissuedunderthefixeddesignationF136;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* F981Practice for Assessment 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 6892Metallic Materials Tensile Testing at Ambient
(R56401) to be used in the manufacture of surgical implants.
Temperature
1.2 Thevaluesstatedininch-poundunitsaretoberegarded
ISO 9001Quality 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
ASQC1SpecificationsofGeneralRequirementsforaQual-
and are not considered standard.
4
ity Control Program
5
2. Referenced Documents 2.4 Aerospace Material Specifications:
AMS 2249Chemical Check Analysis Limits, Titanium and
2
2.1 ASTM Standards:
Titanium Alloys
E8/E8MTest Methods for Tension Testing of Metallic Ma-
AMS 2631Ultrasonic Inspection—Titanium and Titanium
terials
Alloy Bar and Billet
E29Practice for Using Significant Digits in Test Data to
AMS 2380Approval and Control of Premium Quality Tita-
Determine Conformance with Specifications
nium Alloys
E290Test Methods for Bend Testing of Material for Ductil-
ity
3. Terminology
E539TestMethodforAnalysisofTitaniumAlloysbyX-Ray
3.1 Definitions of Terms Specific to This Standard:
Fluorescence Spectrometry
3.1.1 beta transus, n—the minimum temperature at which
E1409TestMethodforDeterminationofOxygenandNitro-
the alpha plus beta phase can transform to 100% beta phase.
gen in Titanium and Titanium Alloys by the Inert Gas
Fusion Technique
3.1.2 lot, n—the total number of mill products produced
E1447Test Method for Determination of Hydrogen in Tita-
fromoneheatunderthesameconditionsatessentiallythesame
nium and Titanium Alloys by Inert Gas Fusion Thermal
time.
Conductivity/Infrared Detection Method
4. Product Classification
E1941Test Method for Determination of Carbon in Refrac-
toryandReactiveMetalsandTheirAlloysbyCombustion
4.1 Strip—Any product under 0.1875 in. (4.76 mm) in
Analysis
thickness and under 24 in. (610 mm) wide.
E2371Test Method for Analysis of Titanium and Titanium
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in
Alloys by Atomic Emission Plasma Spectrometry
thickness and 24 in. (610 mm) or more in width.
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and
1
This specification is under the jurisdiction of ASTM Committee F04 on
over and 10 in. (254 mm) wide and over, with widths greater
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2012. Published December 2012. Originally
3
published in 1984. Last previous edition approved in 2012 as F136–12. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F0136-12A. 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 fromAmerican Society for Quality (ASQ), 600 N. PlankintonAve.,
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 ----------------------
F136−12a
than five times thickness. Plate up to 4.00 in. (101.60 mm), tions by grinding if the resultant area meets the dimensional
thick inclusive is covered by this specification. and surface finish requirements of this specification.
4.4 Bar—Roundbarsandflatsfrom0.1875in.(4.76mm)to 6.3 Condition—Material shall be furnished in the annealed
4.00 in. (101.60 mm) in diameter or thickness (other sizes and or cold-worked condition. Mechanical properties for condi-
shapes by special order). tions other than those listed in Table 1 and Table 2 may be
established by agreement between the supplier and the pur-
4.
...
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: F136 − 12 F136 − 12a
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 F136; 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.
1.2 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:
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 X-Ray Fluorescence Spectrometry
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
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 Atomic Emission Plasma Spectrometry
F981 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
5
2.4 Aerospace Material Specifications:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 2631 Ultrasonic Inspection—Titanium and Titanium Alloy Bar and Billet
AMS 2380 Approval and Control of Premium Quality 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.
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, 2012Dec. 1, 2012. Published November 2012December 2012. Originally published in 1984. Last previous edition approved in 20112012
as F136 – 11.F136 – 12. DOI: 10.1520/F0136-12.10.1520/F0136-12A.
2
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.
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 ----------------------
F136 − 12a
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. (4.76 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.
...
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