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Designation: F 136 – 02a

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 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 (e) 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 the standard. The SI equivalents in parentheses are provided for
information only.
2. Referenced Documents
2.1 ASTM Standards:
E 8 Test Methods of Tension Testing of Metallic Materials2

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 Apr. Nov. 10, 2002. Published June December 2002. Originally published as F 136 – 84. in 1984. Last previous edition F 136 – 98e1. approved
in 2002 as F 136 – 02.

*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.

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 F 136 – 02a
E 120 Test Methods for Chemical Analysis of Titanium and Titanium Alloys3
E 290 Test Method for Bend Testing of Materials for Ductility3
E 527 Practice for Numbering Metals and Alloys (UNS)4
E 1409 Test Methods for Determination of Oxygen in Titanium and Titanium Alloys by the Inert Gas Fusion Technique5
E 1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Thermal
Conductivity Method3
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone6
2.2 ASQ Standard:
ASQ C1 Specifications of General Requirements for a Quality Control Program7
2.3 Aerospace Material Specifications:8
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 4930 Titanium Alloy Bars, Forgings, and Rings 6AL-4V Extra Low Interstitial Annealed
2.4 Society of Automotive Engineers Standard:
SAE J1086 Practice for Numbering Metals and Alloys (UNS)9

3. Product Classification Terminology

3.1 Definitions of Terms Specific to This Standard:
3.1.1 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. (4.75 mm) in thickness and under 24 in. (610 mm) wide.
34.2 Sheet—Any product under 0.1875 in. (4.75 mm) in thickness and 24 in. (610 mm) or more in width.
34.3 Plate—Any product 0.1875 in. (4.75 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.
34.4 Bar—Round bars and flats from 0.1875 in. (4.75 mm) to 4.00 in. (101.60 mm) in diameter or thickness (other sizes and
shapes by special order).
34.5 Forging Bar—Bar as described in 3 4.4, used for production of forgings, may be furnished in the hot rolled condition.
34.6 Wire—Rounds less than 0.1875 in. (4.75 mm) in diameter.

4. Ordering Information
4.1 Include with inquiries and orders for material under this specification the following information:
4.1.1 Quantity,
4.1.2 ASTM designation and date of issue,
4.1.3 Form (sheet, strip, plate, bar, or wire),
4.1.4 Condition (See 5.3),
4.1.5 Mechanical properties (if applicable, for special conditions),
4.1.6 Finish (See 5.2),
4.1.7 Applicable dimensions including size, thickness, width, or drawing number,
4.1.8 Special tests, if any, and
4.1.9 Other requirements.

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, or wire),
5.1.4 Condition (See 6.3),

2
Annual Book of ASTM Standards, Vol 03.01.
3
Annual Book of ASTM Standards, Vol 03.05.
4
Annual Book of ASTM Standards, Vol 01.01.
5
Annual Book of ASTM Standards, Vol 13.01. 03.06.
6
Available from American Society for Quality, 600 N. Plankinton Ave., Milwaukee, WI 53203.
6
Annual Book of ASTM Standards, Vol 13.01.
7
Available from American Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001. for Quality, 600 N. Plankinton Ave.,
Milwaukee, WI 53203.
8
New designation established in accordance with E 527 and SAE J1086.
8
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001.
9
New designation established in accordance with E 527 and SAE J1086.

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 F 136 – 02a
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, or drawing number,
5.1.8 Special tests, if any, and
5.1.9 Other requirements.
6. Materials and Manufacture
56.1 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.
56.2 Finish—The mill product may be furnished to the implant manufacturer as mechanically descaled or pickled, sandblasted,
chemically milled, ground, machined, peeled, polished, combinations of these operations, or as specified by the purchaser.
56.3 Condition—Material shall be furnished in the annealed or cold-worked condition.
67. Chemical Requirements
67.1 The heat analysis shall conform to the chemical composition of Table 1. Ingot analysis may be used for reporting all
chemical requirements, except hydrogen. Samples for hydrogen shall be taken from the finished mill product. Supplier shall not
ship material with chemistry outside the requirements specified in Table 1.
67.1.1 Requirements for the major and minor elemental constituents are listed in Table 1. Also listed are important residual
elements. Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.
67.2 Product Analysis—Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations
between laboratories in the measurement of chemical content. The supplier shall not ship material that is outside the limits specified
in Table 1. The product analysis tolerances shall conform to the product tolerances in Table 2.
67.2.1 The product analysis is either for the purpose of verifying the composition of a heat or manufacturing lot or to determine
variations in the composition within the heat.
67.2.2 Acceptance or rejection of a heat or manufacturing lot of material may be made by the purchaser on the basis of this
product analysis.
67.2.3 For referee purposes, use Test Methods E 120, E 1409, and E 1447 or other analytical methods agreed upon between the
purchaser and the supplier.
67.3 Ensure that the samples for chemical analysis are representative of the material being tested. The utmost care must be used
in sampling titanium for chemical analysis because of its affinity for elements such as oxygen, nitrogen, and hydrogen. In cutting
samples for analysis, therefore, the operation should be carried out insofar as possible in a dust-free atmosphere. Cutting tools
should be clean and sharp. Samples for analysis should be stored in suitable containers.
78. Mechanical Requirements
78.1 The material supplied under this specification shall conform to the mechanical property requirements in Table 3.
78.2 Specimens for tension tests shall be machined and tested in accordance with Test Methods E 8. Tensile properties shall be
determined using a strain rate of 0.003 to 0.007 in./in./min (mm/mm/min) through yield and then the crosshead speed may be
increased so as to produce fracture in approximately one additional minute.
78.3 For sheet and strip, the bend test specimen shall withstand being bent cold through an angle of 105° without fracture in
the outside surface of the bent portion. The bend shall be made around a mandrel which has a diameter equal to that shown in Table
3.
78.4 Number of Tests—Perform a minimum of two:
8.4.1 Bar, Forging Bar, Shapes, and Wire—Perform at least one tension tests from each lot. A lot is defined as the total number
of mill products produced under the same conditions at essentially the same time. Should either any of the two these test specimens
not meet the specified requirements, test two additional test pieces representative of the same lot, in the same manner, for each

TABLE 1 Chemical Requirements

Element Composition, %
Nitrogen, max 0.05
Carbon, max 0.08
Hydrogen, max 0.012A
Iron, max 0.25
Oxygen, max 0.13
Aluminum 5.5–6.50
Vanadium 3.5–4.5
TitaniumB balance
A
Material 0.032 in. (0.813 mm) and under may have hydrogen content up to
0.0150 %.
B
The percentage of titanium is determined by difference and need not be
determined or certified.

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 F 136 – 02a
TABLE 2 Product Analysis ToleranceA
Tolerance Under the Minimum or
Element Over the Maximum Limit
(Composition %)B
Nitrogen 0.02
Carbon 0.02
Hydrogen 0.0020
Iron 0.10
Oxygen 0.02
Aluminum 0.40
Vanadium 0.15
A
See AMS 2249.
B
Under minimum limit not applicable for elements where only a minimum
percentage is indicated.

TABLE 3 Annealed Mechanical PropertiesA

Yield Strength ElongationB in 4D or 4W min,% Reduction of AreaC 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 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 ... ...
2.50 (63.50) to 4.00 (101.60), incl 120 000 (825) 110 000 (760) 8 8D 8D 15 15D 15D
Bend TestE
Under 0.070 (1.778) in thickness 9T
0.070 (1.778) to 0.187 (4.75), incl 10 T
A
Mechanical properties for conditions other than those listed in this table may be established by agreement between the supplier and the implant manufacturer.
B
Elongation of material 0.062 in. (1.575 mm) or greater in diameter or thickness 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. Elongation of material under 0.062 in. (1.575 mm) in diameter or thickness may be obtained by negotiation. L = longitudinal; LT = long
transverse; ST = short transverse.
C
Applies to bar, plate, 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.
D
Transverse requirements in Table 3 apply only to product from which a tensile specimen not less that 2.50 in. (63.5 mm) in length can be obtained.
E
Bend test applicable to sheet and strip products; T = thickness of bend specimen in reference to diameter of bend.

failed test specimen. The lot will be considered in compliance only if both additional test pieces meet the specified requirements.
If a specimen fails outside the gage, the requirements.
8.4.2 Sheet, Strip, and Plate—Perform at least one tension and one bend test is null in accordance with Test Methods E 8, from
each lot. Tension and a retest shall be performed.
8. Special Requirements
8.1 The microstructure shall be a fine dispersion of bend property requirements apply in both the alpha longitudinal and beta
phases resulting from processing transverse directions. Tests in the alpha plus beta field. There shall transverse direction need be
no continuous alpha network at prior beta grain boundaries. There shall be no coarse, elongated alpha platelets.
8.2 Determine the beta transus temperature for each heat by made only on product from which a suitable method specimen not
less than 8.0 in. (200 mm) in length for sheet and r 2.50 in. (64 mm) in lepngth for plate can be taken. Should any of these test
specimens not meet the material certification if required by specified requirements, test two additional test pieces representative
of the purchaser.
8.3 Alpha case is not permitted same lot, in the same manner, for products supplied with a machined, ground, or chemically
milled surface finish. For other products, there each failed test specimen. The lot will be no continuous layer of alpha case when
examined at 1003 magnification. considered in compliance only if both additional test pieces meet the specified requirements.
9. Certification Special Requirements
9.1 The supplier microstructure shall provide be a certification that fine dispersion of the material was tested alpha and beta
phases resulting from processing in accordance with this specification. A report of the test results alpha plus beta field. There shall
be furnished to the purchaser no continuous alpha network at prior beta grain boundaries. There shall be no coarse, elongated alpha
platelets.
9.2 Determine the beta transus temperature for each heat by a suitable method and report on the material certification if required
by the purchaser.
9.3 Alpha case is not permitted for products supplied with a machined, ground, or chemically milled surface finish. For other
products, there will be no continuous layer of alpha case whipen examined at 1003 magnification.
10. Quality Program Requirements Certification
10.1 The producer supplier shall maintain provide a quality program as defined certification that the material was tested in ASQ

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 F 136 – 02a
C1. accordance with this specification. A report of the test results shall be furnished to the purchaser at the time of shipment.
11. Quality Program Requirements
11.1 The producer shall maintain a quality program as defined in ASQ C1.
12. Keywords
112.1 metals (for surgical implants); orthopaedic medical devices; titanium alloys; titanium alloys (for surgical implants)

APPENDIXES

(Nonmandatory Information)

X1. RATIONALE

X1.1 The purpose of this specification is to characterize the chemical, physical, mechanical, and metallurgical properties of
wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy to be used in the manufacture of surgical
implants.

X1.2 The microstructural requirements contained in this standard represent the current general consensus of opinion with
respect to optimization of mechanical properties for implant applications.

X1.3 The minimum mechanical properties specified assure a baseline of strength and ductility for the highly stressed devices
for which this alloy is typically used.

X2. BIOCOMPATIBILITY

X2.1 The alloy composition covered by this specification has been employed successfully in human implant applications in
contact with soft tissue and bone for over a decade. Due to the well-characterized level of biological response exhibited by this
alloy, it has been used as a control material in Practice F 981.

X2.2 No known surgical implant material has ever been shown to be completely free from adverse reactions in the human body.
Long-term clinical experience of the use of the material referred to in this specification, however, has shown that an acceptable
level of biological response can be expected, if the material is used in appropriate applications.

SUMMARY OF CHANGES

Committee F04 has identified the location of selected changes to this standard since the last issue (F 136 –
98e1) 02) that may impact the use of this standard.

(1) Table 3 (Annealed Mechanical Properties) has been changed.) Section 3, Terminology, was added.
(2) The requirement for long transverse tensile specimens) Section 8.4 was revised, and test results has been eliminated for sizes
between 1.75 in. (44.45 mm) to under 2.50 in. (63.50 mm), inclusive, subsections 8.4.1 and a new footnote has been added.
(3) Transverse requirements in Table 3 apply only to product from which a tensile specimen not less that 2.50 in. (63.5mm) in
length can be obtained.
(4) Several editorial changes 8.4.2 were made to update text to current format and style templates. added.

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 F 136 – 02a

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