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.

Designation: F136 − 13 (Reapproved 2021)´1

Standard Specification for

Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications (UNS
R56401)1
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.

ε1 NOTE—X2.2 was updated editorially in August 2021.

1. Scope nium and Titanium Alloys by Inert Gas Fusion Thermal

1.1 This specification covers the chemical, mechanical, and Conductivity/Infrared Detection Method
metallurgical requirements for wrought annealed titanium- E1941 Test Method for Determination of Carbon in Refrac-
6aluminum-4vanadium ELI (extra low interstitial) alloy tory and Reactive Metals and Their Alloys by Combustion
(R56401) to be used in the manufacture of surgical implants. Analysis
E2371 Test Method for Analysis of Titanium and Titanium
1.2 The values stated in inch-pound units are to be regarded Alloys by Direct Current Plasma and Inductively Coupled
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.
iTeh Standards
1.3 This international standard was developed in accor-
F981 Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of

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dance with internationally recognized principles on standard- Materials on Muscle and Insertion into Bone
ization established in the Decision on Principles for the
2.2 ISO Standards: 3
Development of International Standards, Guides and Recom-
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ISO 6892 Metallic Materials Tensile Testing at Ambient
mendations issued by the World Trade Organization Technical
Temperature
Barriers to Trade (TBT) Committee. ISO 9001 Quality Management Systems Requirements
2. Referenced Documents 2.3 ASQ Standard:4
ASTM F136-13(2021)e1
ASQ C1 Specifications of General Requirements for a Qual-
2.1 ASTM Standards:2
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E8/E8M Test Methods for Tension Testing of Metallic Ma- ity Control Program
terials 2.4 Aerospace Material Specifications:5
E29 Practice for Using Significant Digits in Test Data to AMS 2249 Chemical Check Analysis Limits, Titanium and
Determine Conformance with Specifications Titanium Alloys
E290 Test Methods for Bend Testing of Material for Ductil- AMS 2631 Ultrasonic Inspection—Titanium and Titanium
ity Alloy Bar and Billet
E539 Test Method for Analysis of Titanium Alloys by AMS 2380 Approval and Control of Premium Quality Tita-
Wavelength Dispersive X-Ray Fluorescence Spectrometry nium Alloys
E1409 Test Method for Determination of Oxygen and Nitro-
gen in Titanium and Titanium Alloys by Inert Gas Fusion 3. Terminology
E1447 Test 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
1
This specification is under the jurisdiction of ASTM Committee F04 on the alpha plus beta phase can transform to 100 % beta phase.
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
3
published in 1984. Last previous edition approved in 2013 as F136 – 13. DOI: Available from American 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 from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
contact ASTM Customer Service at [email protected]. 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.

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1
 F136 − 13 (2021)´1
3.1.2 lot, n—the total number of mill products produced nonferrous plants. The alloy is usually multiple melted in arc
from one heat under the same conditions at essentially the same furnaces (including furnaces such as plasma arc and electron
time. beam) of a type conventionally used for reactive metals.
4. Product Classification 6.2 Finish—The mill product may be furnished to the
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
thickness and 24 in. (610 mm) or more in width. forgings, it is permissible to remove minor surface imperfec-
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and tions by grinding if the resultant area meets the dimensional
over and 10 in. (254 mm) wide and over, with widths greater and surface finish requirements of this specification.
than five times thickness. Plate up to 4.00 in. (101.60 mm), 6.3 Condition—Material shall be furnished in the annealed
thick inclusive is covered by this specification. or cold-worked condition. Mechanical properties for condi-
4.4 Bar—Round bars and flats from 0.1875 in. (4.76 mm) to tions other than those listed in Tables 1 and 2 may be
4.00 in. (101.60 mm) in diameter or thickness (other sizes and established by agreement between the supplier and the pur-
shapes by special order). chaser.

4.5 Forging Bar—Bar as described in 4.4, used for produc- 7. Chemical Requirements
tion of forgings, may be furnished in the hot worked condition.
7.1 The heat analysis shall conform to the chemical com-
4.6 Wire—Rounds, flats, or other shapes less than 0.1875 in. position specified in Table 3. Ingot analysis may be used for
(4.76 mm) in diameter. reporting all chemical requirements, except hydrogen. Samples
4.7 Other—Other forms and shapes, including tubing, may for hydrogen shall be taken from the finished mill product. The
be provided by agreement between purchaser and supplier. supplier shall not ship material with chemistry outside the
requirements specified in Table 3.
5. Ordering Information
iTeh Standards
5.1 Include with inquiries and orders for material under this
7.1.1 Requirements for the major and minor elemental
constituents are listed in Table 3. Also listed are important

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specification the following information: residual elements. Analysis for elements not listed in Table 3 is
5.1.1 Quantity, not required to verify compliance with this specification.

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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), ASTM F136-13(2021)e1
product analysis tolerances shall conform to the product
5.1.6 Finish (see 6.2), tolerances in Table 4.
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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 Acceptance or rejection of a heat or manufacturing lot
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- referee analysis may be used if agreed upon by the supplier and
ing and rolling equipment found in primary ferrous and purchaser.

TABLE 1 Annealed Mechanical Properties of Bar, Wire, and Forgings

Yield Strength ElongationA in 4D or 4W min, % Reduction of AreaB min, %
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 ... ...
2.50 (63.50) to 4.00 (101.60), incl 120 000 (825) 110 000 (760) 8 8C 8C 15 15C 15C
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.