ASTM F1813-97e1

Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)

SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium - 12 molybdenum - 6 zirconium - 2 iron alloy 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 given in parentheses are provided for information only.

General Information

• Status: Historical
• Publication Date: 09-Oct-2001
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaced By: ASTM F1813-01 - Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 10-Oct-2001

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e1
Designation: F 1813 – 97
Standard Specification for
Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron
Alloy For Surgical Implant Applications
This standard is issued under the fixed designation F 1813; 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.
e NOTE—Footnote 1 was editorially revised June 2000.
1. Scope 2.2 Aerospace Materials Specification:
AMS 2249 Chemical Check Analysis Limits, Titanium and
1.1 This specification covers the chemical, mechanical and
Titanium Alloys
metallurgical requirements for wrought Ti-12 Mo-6 Zr-2 Fe
2.3 American Society for Quality Standard:
alloy to be used in the manufacture of surgical implants .
ASQ C1 Specification of General Requirements for a Qual-
1.2 The values stated in inch-pound units are to be regarded
ity Program
as the standard. The metric equivalents given in parentheses are
provided for information only.
3. Ordering Information
2. Referenced Documents 3.1 Inquiries and orders for material under this specification
shall include the following information:
2.1 ASTM Standards:
3.1.1 Quantity (weight or number of pieces),
B 348 Specification for Titanium and Titanium Alloy Bars
3.1.2 ASTM Designation,
and Billets
4 3.1.3 Dimensions,
E 8 Test Methods for Tension Testing of Metallic Materials
3.1.4 Condition,
E 112 Test Methods for Determining Average Grain Size
3.1.5 Finish (see 4.2), and
E 120 Test Methods for Chemical Analysis of Titanium and
3.1.6 Special requirements.
Titanium Alloys
E 1409 Test Method for the Determination of Oxygen in
4. Materials and Manufacture
Titanium and Titanium Alloys by the Inert Gas Fusion
4.1 The titanium mill products covered in this specification
Technique
are normally formed with the conventional forging, rolling or
E 1447 Test Method for the Determination of Hydrogen in
other metal processing equipment found in primary ferrous and
Titanium and Titanium Alloys by the Inert Gas Fusion
4 nonferrous plants. The ingot metal for such mill operations is
Thermal Conductivity Method
usually multiple melted in arc furnaces (including furnaces
F 748 Practice for Selecting Generic Biological Test Meth-
6 such as plasma arc and electron beam) of a type conventionally
ods for Materials and Devices
used for reactive metals.
F 750 Practice for Evaluating Material Extracts by System-
6 4.2 Finish—Annealed material may be furnished to the
atic Injection in the Mouse
implant manufacturer as descaled or pickled, sandblasted,
F 895 Test Method for Agar Diffusion Cell Culture Screen-
6 machined, ground, or combinations of these operations.
ing for Cytotoxicity
F 981 Practice for Assessment of Compatibility of Bioma-
5. Chemical Requirements
terials (Non-Porous) for Surgical Implants with Respect to
6 5.1 The heat analysis shall conform to the chemical com-
Effect of Materials on Muscle and Bone
position of Table 1. Ingot analysis may be used for reporting all
chemical requirements, except hydrogen. Samples for hydro-
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
gen shall be taken from the finished mill product.
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
5.2 Product Analysis— Product analysis tolerances do not
F0.4.12 on Metallurgical Materials.
Current edition approved June 10, 1997. Published June 1998.
broaden the specified heat analysis requirements but cover
Wang, K., Gustavson, L., Dumbleton, J., “The Characterization of Ti-12Mo-
variations between laboratories in the measurement of chemi-
6Zr-2Fe - A New Biocompatible Alloy Developed for Surgical Implants”, Beta
cal content. The manufacturer shall not ship material that is
Titanium Alloys in the 1990’s, Proceedings of a Symposium on Beta Titanium
Alloys held at the 1993 Annual TMS meeting in Denver, Colorado, February 22–24, outside the limits specified in Table 1. Product analysis limits
1993.
Annual Book of ASTM Standards, Vol 02.04.
4 7
Annual Book of ASTM Standards, Vol 03.01. Available from SAE; 400 Commonwealth Drive, Warrendale, PA 15096.
5 8
Annual Book of ASTM Standards, Vol 03.05. Available from American Society for Quality; 161 West Wisconsin Avenue,
Annual Book of ASTM Standards, Vol 13.01. Milwaukee, WI 53203.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 1813
TABLE 1 Chemical Requirements TABLE 3 Mechanical Properties of Ti-12Mo-6Zr-2Fe Bar and
A
Wire
Composition, Weight %
Element
Ultimate Tensile Yield Strength
B
Minimum Maximum
Elongation Reduction in
Condition Strength, min, (0.2 %), min,
min, % Area min. (%)
Molybdenum 10.0 13.0 psi (MPa) psi (MPa)
C
Zirconium 5.0 7.0 Solution 135 000 (931.5) 130 000 (897) 12 30
Iron 1.5 2.5
Annealed
Oxygen 0.08 0.28
A
Diameter 0.10 in. (2.54 mm) to 1 ⁄2 in. (38.1 mm).
Nitrogen — 0.05
B
Gage length 5 4 3 diameter.
Carbon — 0.05
C
Solution annealing shall be performed at 1450 6 25°F (7886 14°C) followed by
Hydrogen — 0.020
a rapid quench to below 300°F ( °C), for an appropriate time, as required to meet
A
Titanium Balance Balance
grain size and mechanical property requirements.
A
The percentage of titanium is determined by difference and need not be
determined or certified.
0.003 to 0.007 in./in./min (mm/mm/min) through the specified
yield strength, and then the cross-head speed shall be increased
shall be as specified in Table 2.
so as to produce fracture in approximately one additional
5.2.1 The product analysis is either for the purpose of
minute.
verifying the composition of a heat or lot or to determine
6.3 Number of Tests— A minimum of two tension tests shall
variations in the composition within the heat.
be made from each lot. A lot is defined as the total number of
5.3 For referee purposes, Test Methods E 120, E 1409 and
mill products produced under the same conditions at essentially
E 1447 or other analytical methods agreed upon by purchaser
the same time. Should either of the test specimens not meet the
and supplier shall be used.
specific requirements two additional test pieces representative
5.4 Samples for chemical analysis shall be representative of
of the same lot shall be tested in the same manner. The lot shall
the material being tested. The utmost care must be used in
be deemed to comply only if b
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