ASTM F136-13

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.

General Information

• Status: Historical
• Publication Date: 31-Oct-2013
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F136 −13
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications (UNS
R56401)
ThisstandardisissuedunderthefixeddesignationF136;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* Based Test Methodology)
F981Practice for Assessment of Compatibility of Biomate-
1.1 This specification covers the chemical, mechanical, and
rials for Surgical Implants with Respect to Effect of
metallurgical requirements for wrought annealed titanium-
Materials on Muscle and Bone
6aluminum-4vanadium ELI (extra low interstitial) alloy
(R56401) to be used in the manufacture of surgical implants. 2.2 ISO Standards:
ISO 6892Metallic Materials Tensile Testing at Ambient
1.2 Thevaluesstatedininch-poundunitsaretoberegarded
Temperature
as standard. The values given in parentheses are mathematical
ISO 9001Quality Management Systems Requirements
conversions to SI units that are provided for information only
2.3 ASQ Standard:
and are not considered standard.
ASQC1SpecificationsofGeneralRequirementsforaQual-
2. Referenced Documents
ity Control Program
2.1 ASTM Standards:
2.4 Aerospace Material Specifications:
E8/E8MTest Methods for Tension Testing of Metallic Ma-
AMS 2249Chemical Check Analysis Limits, Titanium and
terials
Titanium Alloys
E29Practice for Using Significant Digits in Test Data to
AMS 2631Ultrasonic Inspection—Titanium and Titanium
Determine Conformance with Specifications
Alloy Bar and Billet
E290Test Methods for Bend Testing of Material for Ductil-
AMS 2380Approval and Control of Premium Quality Tita-
ity
nium Alloys
E539TestMethodforAnalysisofTitaniumAlloysbyX-Ray
Fluorescence Spectrometry
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
3.1.2 lot, n—the total number of mill products produced
Conductivity/Infrared Detection Method
fromoneheatunderthesameconditionsatessentiallythesame
E1941Test Method for Determination of Carbon in Refrac-
time.
toryandReactiveMetalsandTheirAlloysbyCombustion
Analysis
4. Product Classification
E2371Test Method for Analysis of Titanium and Titanium
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
4.1 Strip—Any product under 0.1875 in. (4.76 mm) in
Plasma Atomic Emission Spectrometry (Performance-
thickness and under 24 in. (610 mm) wide.
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in
1 thickness and 24 in. (610 mm) or more in width.
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, 2013. Published December 2013. Originally
published in 1984. Last previous edition approved in 2012 as F136–12a. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F0136-13. 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 [e-mail]. For Annual Book of ASTM Milwaukee, WI 53203, http://www.asq.org.
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
F136−13
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and forgings, it is permissible to remove minor surface imperfec-
over and 10 in. (254 mm) wide and over, with widths greater tions by grinding if the resultant area meets the dimensional
than five times thickness. Plate up to 4.00 in. (101.60 mm), and surface finish requirements of this specification.
thick inclusive is covered by this specification.
6.3 Condition—Material shall be furnished in the annealed
4.4 Bar—Roundbarsandflatsfrom0.1875in.(4.76mm)to or cold-worked condition. Mechanical properties for condi-
4.00 in. (101.60 mm) in diameter or thickness (other sizes and tions other than those listed in Table 1 and Table 2 may be
shapes by special order). established by agreement between the supplier and the pur-
chaser.
4.5 Forging Bar—Bar as described in 4.4, used for produc-
tionofforgings,maybefurnishedinthehotworkedcondition.
7. Chemical Requirements
4.6 Wire—Rounds,flats,orothershapeslessthan0.1875in.
7.1 The heat analysis shall conform to the chemical com-
(4.76 mm) in diameter.
position specified in Table 3. Ingot analysis may be used for
reportingallchemicalrequirements,excepthydrogen.Samples
4.7 Other—Other forms and shapes, including tubing, may
forhydrogenshallbetakenfromthefinishedmillproduct.The
be provided by agreement between purchaser and supplier.
supplier shall not ship material with chemistry outside the
5. Ordering Information
requirements specified in Table 3.
7.1.1 Requirements for the major and minor elemental
5.1 Include with inquiries and orders for material under this
constituents are listed in Table 3. Also listed are important
specification the following information:
residualelements.AnalysisforelementsnotlistedinTable3is
5.1.1 Quantity,
not required to verify compliance with this specification.
5.1.2 ASTM designation and date of issue,
5.1.3 Form (sheet, strip, plate, bar, forging bar, or wire),
7.2 Product Analysis:
5.1.4 Condition (See Section 3 and 6.3),
7.2.1 Product analysis tolerances do not broaden the speci-
5.1.5 Mechanical properties (if applicable, for special
fied heat analysis requirements but cover variations between
conditions),
laboratories in the measurement of chemical content. The
5.1.6 Finish (See 6.2),
product analysis tolerances shall conform to the product
5.1.7 Applicable dimensions including size, thickness,
tolerances in Table 4.
width, length, or drawing number,
7.2.2 The product analysis is either for the purpose of
5.1.8 Special tests, if any, and
verifying the composition of a heat or manufacturing lot or
5.1.9 Other requirements.
determining variations in the composition within the heat.
7.2.3 Acceptanceorrejectionofaheatormanufacturinglot
6. Materials and Manufacture
of material may be made by the purchaser on the basis of this
6.1 The various titanium mill products covered in this product analysis. Product analysis outside the tolerance limits
specification normally are formed with the conventional forg- allowed in Table 4 is cause for rejection of the product. A
ing and rolling equipment found in primary ferrous and refereeanalysismaybeusedifagreeduponbythesupplierand
nonferrous plants. The alloy is usually multiple melted in arc purchaser.
furnaces (including furnaces such as plasma arc and electron 7.2.4 For referee purposes, use Test Methods E539, E1409,
beam) of a type conventionally used for reactive metals. E1447, E1941, and E2371 or other analytical methods agreed
upon between the purchaser and the supplier.
6.2 Finish—The mill product may be furnished to the
implant manufacturer as mechanically descaled or pickled, 7.3 Samplesforchemicalanalysisshallberepresentativeof
abrasively blasted, chemically milled, ground, machined, the material being tested. The utmost care must be used in
peeled, polished, combinations of these operations, or as sampling titanium for chemical analysis because of its affinity
specified by the purchaser. On billets, bars, plates, and for elements such as oxygen, nitrogen, and hydrogen. In
TABLE 1 Annealed Mechanical Properties of Bar, Wire, and Forgings
A B
Elongation in 4D or 4W min, % Reduction of Area min, %
Yield Strength
Nominal Diameter or Distance Tensile Strength min,
(0.2 % offset) min,
L LT ST L LT ST
Between Parallel Sides, in. (mm) psi (MPa)
psi (MPa)
— — — — — —
Under 0.187 (4.75) thickness or 125 000 (860) 115 000 (795) 10 . . . . .
diameter
0.187 (4.75) to under 1.75 (44.45), incl 125 000 (860) 115 000 (795) 10 . . 25 . .
1.75 (44.45) to under 2.50 (63.50), incl 120 000 (825) 110 000 (760) 8 . . 20 . .
C C C C
2.50 (63.50) to 4.00 (101.60), incl 120 000 (825) 110 000 (760) 8 8 8 15 15 15
A
Elongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W) shall be measured using a gage length of 2 in. or4Dor4W. The gage length must
be reported with the test results. The method for determining elongation of material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated. Alternatively,
a gage length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser. (5.65 times the square root of So, where So is the original
cross sectional area.) Gage length shall be reported with the elongation value. L = longitudinal; LT = long transverse; ST = short transverse.
B
Applies to bar and forgings only. L = longitudinal; LT = long transverse; ST = short transverse. For round bar, the long and short transverse are identical tests, therefore
only one transverse is required.
C
Transverse requirements in Table 1 apply only to product from which a tensile specimen not less that 2.50 in. (63.5 mm) in length can be obtained.
F136−13
TABLE 2 Annealed Mechanical Properties of Sheet, Strip, and
...

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 − 12a F136 − 13
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications (UNS
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
2.1 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 Inert Gas Fusion
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 Direct Current Plasma and Inductively Coupled Plasma
Atomic Emission Spectrometry (Performance-Based Test Methodology)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
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
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.
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 Dec. 1, 2012Nov. 1, 2013. Published December 2012December 2013. Originally published in 1984. Last previous edition approved in 2012 as
F136 – 12.F136 – 12a. DOI: 10.1520/F0136-12A.10.1520/F0136-13.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
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
F136 − 13
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. (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, used for production of forgings, may be furnished in the hot worked condition.
4.6 Wire—Rounds, flats, or other shapes less than 0.1875 in. (4.76 mm) in diameter.
4.7 Other—Other forms and shapes, including tubing, may be provided by agreement between purchaser and supplier.
5. Ordering Information
5.1 Include with inquiries and orders for material under this specification the following information:
5.1.1 Quantity,
5.1.2 ASTM designation and date of issue,
5.1.3 Form (sheet, strip, plate, bar, forging bar, or wire),
5.1.4 Condition (See Section 3 and 6.3),
5.1.5 Mechanical properties (if applicable, for special conditions),
5.1.6 Finish (See 6.2),
5.1.7 Applicable dimensions including size, thickness, width, length, or drawing number,
5.1.8 Special tests, if any, and
5.1.9 Other requirements.
6. Materials and Manufacture
6.1 The various titanium mill products covered in this specification normally are formed with the conventional forging and
rolling equipment found in primary ferrous and nonferrous plants. The alloy is usually multiple melted in arc furnaces (including
furnaces such as plasma arc and electron beam) of a type conventionally used for reactive metals.
6.2 Finish—The mill product may be furnished to the implant manufacturer as mechanically descaled or pickled, abrasively
blasted, chemically milled, ground, machined, peeled, polished, combinations of these operations, or as specified by the purchaser.
On billets, bars, plates, and forgings, it is permissible to remove minor surface imperfections by grinding if the resultant area meets
the dimensional and surface finish requirements of this specification.
6.3 Condition—Material shall be furnished in the annealed or cold-worked condition. Mechanical properties for conditions other
than those listed in Table 1 and Table 2 may be established by agreement between the supplier and the purchaser.
7. Chemical Requirements
7.1 The heat analysis shall conform to the chemical composition specified in Table 3. Ingot analysis may be used for reporting
all chemical requirements, except hydrogen. Samples for hydrogen shall be taken from the finished mill product. The supplier shall
not ship material with chemistry outside the requirements specified in Table 3.
TABLE 1 Annealed Mechanical Properties of Bar, Wire, and Forgings
A B
Elongation in 4D or 4W min, % Reduction of Area min, %
Yield Strength
Nominal Diameter or Distance Tensile Strength min,
(0.2 % offset) min,
L LT ST L LT ST
Between Parallel Sides, in. (mm) psi (MPa)
psi (MPa)
— — — — — —
Under 0.187 (4.75) thickness or 125 000 (860) 115 000 (795) 10 . . . . .
diameter
0.187 (4.75) to under 1.75 (44.45), incl 125 000 (860) 115 000 (795) 10 . . 25 . .
1.75 (44.45) to under 2.50 (63.50), incl 120 000 (825) 110 000 (760) 8 . . 20 . .
C C C C
2.50 (63.50) to 4.00 (101.60), incl 120 000 (825) 110 000 (760) 8 8 8 15 15 15
A
Elongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W) shall be measured using a gage length of 2 in. or 4 D or 4 W. The gage length must
be reported with the test results. The method for determining elongation of material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated. Alternatively,
a gage length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser. (5.65 times the square root of So, where So is the original
cross sectional area.) Gage length shall be reported with the elongation value. L = longitudinal; LT = long transverse; ST = short transverse.
B
Applies to bar and forgings only. L = longitudinal; LT = long transverse; ST = short transverse. For round bar, the long and short transverse are identical tests, therefore
only one transverse is required.
C
Transverse requirements in Table 1 apply only to product from which a tensile specimen not less that 2.50 in. (63.5 mm) in length can be obtained.
F136 − 13
TABLE 2 Annealed Mechanical Properties of Sheet, Strip, and Plate
A
Bend Test
Elongation in 2 in. (50 mm), B
Reduction of Area min, %
C,D
min, % Mandrel Diameter
0.070 to
Nominal Diameter Tensile Strength Yield Strength
Under
0.1875 in.
or Distance Between min, (0.2 % offset) min,
0.070 in.
L LT ST L LT ST (1.78 to
Parallel Sides, in. (mm) psi (MPa) psi (MPa)
(1.78 mm)
— — — — — — 4.75 mm)
in
in
Thickness
Thickness
Under 0.187 (4.75) 125 000 (860) 115 000 (795) 10 . . . . . 9T 10T
thickness or diameter
0.187 (4.75) to under 125 000 (860) 115 000 (795) 10 . . 25 . . . .
1.75 (44.45), incl
1.75 (44.45) to under 120 000 (825) 110 000 (760) 8 . . 20 . . . .
2.50 (63.50), incl
E E E E
2.50 (63.50) to 120 000 (825) 110 000 (760) 8 8 8 15 15 15 . .
4.00 (101.60), incl
A
Elongation of material 0.063 in. (1.6 mm) or greater width (W) shall be measured using a gage length of 2 in. or 4 W. The gage length must be reported with the test
results. The method for determining elongation of material less than 0.063 in. (1.6 mm) in thickness may be negotiated. Alternatively, a gage length corresponding to ISO
6892 may be used when agreed upon between supplier and purchaser. (5.65 times the square root of So, where So is the original cross sectional area.) Gage length shall
be reported with the elongation value. L = longitudinal; LT = long transverse; ST = short transverse.
B
Applies to plate only. L = longitudinal; LT = long transverse; ST = short trans
...