ASTM F136-13(2021)e1
(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.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Relations
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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Designation:F136 −13 (Reapproved 2021)
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.
ε NOTE—X2.2 was updated editorially in August 2021.
1. Scope nium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
1.1 This specification covers the chemical, mechanical, and
E1941Test Method for Determination of Carbon in Refrac-
metallurgical requirements for wrought annealed titanium-
toryandReactiveMetalsandTheirAlloysbyCombustion
6aluminum-4vanadium ELI (extra low interstitial) alloy
Analysis
(R56401) to be used in the manufacture of surgical implants.
E2371Test Method for Analysis of Titanium and Titanium
1.2 Thevaluesstatedininch-poundunitsaretoberegarded
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
as standard. The values given in parentheses are mathematical
Plasma Atomic Emission Spectrometry (Performance-
conversions to SI units that are provided for information only
Based Test Methodology)
and are not considered standard.
F981Practice for Assessment of Compatibility of Biomate-
1.3 This international standard was developed in accor-
rials for Surgical Implants with Respect to Effect of
dance with internationally recognized principles on standard- Materials on Muscle and Insertion into Bone
ization established in the Decision on Principles for the 3
2.2 ISO Standards:
Development of International Standards, Guides and Recom-
ISO 6892Metallic Materials Tensile Testing at Ambient
mendations issued by the World Trade Organization Technical
Temperature
Barriers to Trade (TBT) Committee.
ISO 9001Quality Management Systems Requirements
2.3 ASQ Standard:
2. Referenced Documents
2 ASQC1SpecificationsofGeneralRequirementsforaQual-
2.1 ASTM Standards:
ity Control Program
E8/E8MTest Methods for Tension Testing of Metallic Ma-
2.4 Aerospace Material Specifications:
terials
AMS 2249Chemical Check Analysis Limits, Titanium and
E29Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications Titanium Alloys
AMS 2631Ultrasonic Inspection—Titanium and Titanium
E290Test Methods for Bend Testing of Material for Ductil-
ity Alloy Bar and Billet
AMS 2380Approval and Control of Premium Quality Tita-
E539Test Method for Analysis of Titanium Alloys by
WavelengthDispersiveX-RayFluorescenceSpectrometry nium Alloys
E1409TestMethodforDeterminationofOxygenandNitro-
gen in Titanium and TitaniumAlloys by Inert Gas Fusion 3. Terminology
E1447Test Method for Determination of Hydrogen in Tita-
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 Aug. 15, 2021. Published August 2021. Originally
published in 1984. Last previous edition approved in 2013 as F136–13. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F0136-13R21E01. 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.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F136−13 (2021)
3.1.2 lot, n—the total number of mill products produced nonferrous plants. The alloy is usually multiple melted in arc
fromoneheatunderthesameconditionsatessentiallythesame furnaces (including furnaces such as plasma arc and electron
time. beam) of a type conventionally used for reactive metals.
6.2 Finish—The mill product may be furnished to the
4. Product Classification
implant manufacturer as mechanically descaled or pickled,
4.1 Strip—Any product under 0.1875 in. (4.76 mm) in
abrasively blasted, chemically milled, ground, machined,
thickness and under 24 in. (610 mm) wide.
peeled, polished, combinations of these operations, or as
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in specified by the purchaser. On billets, bars, plates, and
forgings, it is permissible to remove minor surface imperfec-
thickness and 24 in. (610 mm) or more in width.
tions by grinding if the resultant area meets the dimensional
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and
and surface finish requirements of this specification.
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), 6.3 Condition—Material shall be furnished in the annealed
or cold-worked condition. Mechanical properties for condi-
thick inclusive is covered by this specification.
tions other than those listed in Tables 1 and 2 may be
4.4 Bar—Roundbarsandflatsfrom0.1875in.(4.76mm)to
established by agreement between the supplier and the pur-
4.00 in. (101.60 mm) in diameter or thickness (other sizes and
chaser.
shapes by special order).
4.5 Forging Bar—Bar as described in 4.4, used for produc-
7. Chemical Requirements
tionofforgings,maybefurnishedinthehotworkedcondition.
7.1 The heat analysis shall conform to the chemical com-
4.6 Wire—Rounds,flats,orothershapeslessthan0.1875in.
position specified in Table 3. Ingot analysis may be used for
(4.76 mm) in diameter.
reportingallchemicalrequirements,excepthydrogen.Samples
forhydrogenshallbetakenfromthefinishedmillproduct.The
4.7 Other—Other forms and shapes, including tubing, may
supplier shall not ship material with chemistry outside the
be provided by agreement between purchaser and supplier.
requirements specified in Table 3.
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
residualelements.AnalysisforelementsnotlistedinTable3is
specification the following information:
not required to verify compliance with this specification.
5.1.1 Quantity,
5.1.2 ASTM designation and date of issue,
7.2 Product Analysis:
5.1.3 Form (sheet, strip, plate, bar, forging bar, or wire),
7.2.1 Product analysis tolerances do not broaden the speci-
5.1.4 Condition (see Section 3 and 6.3),
fied heat analysis requirements but cover variations between
5.1.5 Mechanical properties (if applicable, for special
laboratories in the measurement of chemical content. The
conditions),
product analysis tolerances shall conform to the product
5.1.6 Finish (see 6.2),
tolerances in Table 4.
5.1.7 Applicable dimensions including size, thickness,
7.2.2 The product analysis is either for the purpose of
width, length, or drawing number,
verifying the composition of a heat or manufacturing lot or
5.1.8 Special tests, if any, and
determining variations in the composition within the heat.
5.1.9 Other requirements. 7.2.3 Acceptanceorrejectionofaheatormanufacturinglot
of material may be made by the purchaser on the basis of this
6. Materials and Manufacture
product analysis. Product analysis outside the tolerance limits
6.1 The various titanium mill products covered in this allowed in Table 4 is cause for rejection of the product. A
specification normally are formed with the conventional forg- refereeanalysismaybeusedifagreeduponbythesupplierand
ing and rolling equipment found in primary ferrous and purchaser.
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 diameter 125 000 (860) 115 000 (795) 10 . . . . .
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.
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F136−13 (2021)
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
Nomi
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