ASTM F1713-96
(Specification)Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications
Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-13niobium-13zirconium alloy to be used in the manufacture of surgical implants (1).
1.2 The values stated in inch pound units are to be regarded as the standard. The metric equivalents in parentheses are provided for information only.
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Standards Content (Sample)
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1713 – 96
Standard Specification for
Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical
Implant Applications
This standard is issued under the fixed designation F 1713; 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 3. Terminology
1.1 This specification covers the chemical, mechanical, and 3.1 Definitions of Terms Specific to This Standard:
metallurgical requirements for wrought titanium13niobium- 3.1.1 capability aged, n—the condition of the material that
13zirconium alloy to be used in the manufacture of surgical is obtained if, following solution treatment, a sample of the
implants (1). mill product is subjected to an aging treatment such as given
1.2 The values stated in inch pound units are to be regarded below, for certification testing.
as the standard. The metric equivalents in parentheses are 3.1.1.1 Ramp up from room temperature to 923 6 25°F
provided for information only. (495 6 14°C) over 2.5 6 1h.
3.1.1.2 Age for 6 6 0.25 h at 923 6 25°F (495 6 14°C).
2. Referenced Documents
3.1.1.3 Remove from furnace and air cool to room tempera-
2.1 ASTM Standards:
ture.
E 8 Methods of Tension Testing of Metallic Materials 3.1.2 solution treated, n—the condition of the material that
E 120 Test Methods for Chemical Analysis of Titanium and
is obtained if, following the final hot-working or cold-working
Titanium Alloys operation, the mill product is rapidly quenched, for example,
E 1409 Test Method for the Determination of Oxygen in
by water quenching, from a temperature above 1112°F
Titanium and Titanium Alloys by the Inert Gas Fusion (600°C).
Technique
3.1.3 unannealed, n—the condition of the material that is
E 1447 Test Method for the Determination of Hydrogen in obtained after the normal hot-working or cold-working opera-
Titanium and Titanium Alloys by the Inert Gas Fusion
tion used for fabrication of the mill product. There are no
Thermal Conductivity Method
subsequent heat treatment requirements.
F 748 Practice for Selecting Generic Biological Test Meth-
5 4. Product Classification
ods for Materials and Devices
F 981 Practice for Assessment of Compatibility of Bioma- 4.1 Strip—Any product under 0.1875 in. (4.75 mm) in
terials for Surgical Implants with Respect to Effect of thickness and under 24 in. (610 mm) wide.
Materials on Muscle and Bone 4.2 Sheet—Any product under 0.1875 in. (4.75 mm) in
F 1472 Specification for Wrought TI-6AI-4V Alloy for thickness and 24 in. (610 mm) or more in width.
Surgical Implant Applications 4.3 Plate—Any product 0.1875 in. (4.75 mm) thick and
2.2 Other Standards: over and 10 in. (254 mm) wide and over, with widths greater
ASOC C1 Specification of General Requirements for a than five times thickness. Plate up to 4 in. (101.60 mm), thick
Quality Control Program inclusive is covered by this specification.
AMS 2249 Chemical Check Analysis Limits, Titanium and 4.4 Bar—Rounds or flats from ⁄16 in. (4.75 mm) to 4 in.
Titanium Alloys (101.60 mm) in diameter or thickness. (Other sizes and shapes
by special order.)
4.5 Wire—Rounds less than ⁄16 in. (75 mm) in diameter.
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
5. Ordering Information
F04.12 on Metallurgical Materials.
5.1 Include with inquiries and orders for material under this
Current edition approved July 10, 1996. Published August 1996.
The boldface numbers in parentheses refer to the list of references at the end of
specification the following information.
the text.
5.1.1 Quantity (weight or number of pieces),
Annual Book of ASTM Standards, Vol 03.01.
5.1.2 Applicable ASTM designation,
Annual Book of ASTM Standards, Vol 03.05.
5.1.3 Form (sheet, strip, plate, wire, or bar),
Annual Book of ASTM Standards, Vol 13.01.
Available from the American Society for Quality Control, 161 W. Wisconsin
5.1.4 Condition (see Section 3 and 6.1),
Ave., Milwaukee, WI 53203.
5.1.5 Mechanical properties (if applicable, for special con-
Available from the Society of Automotive Engineers, 400 Commonwealth
ditions),
Drive, Warrendale, PA 15096.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1713
A
TABLE 2 Product Analysis Tolerance
5.1.6 Finish (see 6.2),
5.1.7 Applicable dimensions including size, thickness, Tolerance Under the Minimum or
Element
B
Over the Maximum Limit
width, or print number,
Nitrogen 0.02
5.1.8 Special tests, and
Carbon 0.02
5.1.9 Special requirements.
Hydrogen 0.0020
Iron 0.10
6. Materials and Manufacture
Oxygen 0.02
Niobium 0.30
6.1 The various titanium mill products covered in this
Zirconium 0.40
specification normally are formed with the conventional forg-
A
Refer to AMS 2249.
ing and rolling equipment found in primary ferrous and
B
Under the minimum limit not applicable for elements where only a maximum
nonferrous plants. The ingot metal for such mill operations is
percentage is indicated.
usually multiple melted in arc furnaces (including furnaces
such as plasma arc and electron beam) of a type conventionally
conforms to the mechanical property requirements given in
used for reactive metals.
Table 3.
6.2 Finish—The mill product may be furnished to the
8.2 Specimens for tension tests shall be machined and tested
implant manufacturer as descaled or pickled, sandblasted,
in accordance with Test Methods E 8. Tensile properties shall
ground, machined, or combinations of these operations.
be determined using a strain rate of 0.003 to 0.007 in./in./min
(mm/mm/min) through the specified yield strength, and then
7. Chemical Requirements
the cross-head speed shall be increased so as to produce
7.1 Ensure that the heat analysis conforms to the chemical
fracture in approximately one additional minute.
composition of Table 1. Ingot analysis may be used for
8.3 Number of Tests—Perform a minimum of two tension
reporting all chemical requirements, except hydrogen. Take
tests from each lot. A lot is defined as the total number of mill
samples for hydrogen from the finished mill product.
products produced under the same conditions at essentially the
7.1.1 Requirements for the major and minor elemental
same time. Should either of the two test specimens not meet the
constituents are listed in Table 1. Also listed are important
specified requirements, test two additional test pieces represen-
residual elements. Analysis for elements not listed in Table 1 is
tative of the same lot in the same manner. The lot will be
not required to verify compliance with this specification.
considered in compliance only if both additional test pieces
7.2 Product analysis tolerances do not broaden the specified
meet the specified requirements. If a specimen fails outside the
heat analysis requirements but cover variations between labo-
gage, the test is null in accordance with Methods E 8, and a
ratories in the measurement of chemical content. The manu-
retest shall be performed.
facturer shall not ship material that is outside the limits
9. Special Requirements
specified in Table 1. Ensure that the product analysis tolerances
conform to the check tolerances of Table 2.
9.1 Ensure that the microstructure is martensitic with finely
7.3 For referee purposes, use Methods E 120 or other
dispersed alpha or beta phases, or both. The alpha or beta
analytical methods agreed upon between the purchaser and the
phases, or both, may be too fine to be visible metallographi-
supplier.
cally but must be present to ensure adequate strength. No
7.4 Ensure that the samples for chemical analysis are
continuous alpha network at prior beta grain boundaries will be
representative of the material being tested. The utmost care
present. The microstructure within the prior beta grain bound-
must be used in sampling titanium for chemical analysis
aries will be acicular. Perform metallographic evaluation in the
because of its affinity for elements such as oxygen, nit
...
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