ASTM F1813-01
(Specification)Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
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
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn. Contact ASTM
International (www.astm.org) for the latest information.
Designation: F 1813 – 01
Standard Specification for
Wrought Titanium – 12 Molybdenum – 6 Zirconium – 2 Iron
1
Alloy for Surgical Implant (UNS R58120)
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.
TABLE 1 Chemical Requirements
1. Scope*
Composition %, Mass/Mass
1.1 This specification covers the chemical, mechanical, and
Element
Min Max
metallurgical requirements for wrought titanium – 12 molyb-
denum – 6 zirconium – 2 iron alloy to be used in the
Molybdenum 10.0 13.0
2
Zirconium 5.0 7.0
manufacture of surgical implants.
Iron 1.5 2.5
1.2 The values stated in inch-pound units are to be regarded
Oxygen 0.008 0.28
as the standard. The SI equivalents given in parentheses are Nitrogen — 0.05
Carbon — 0.05
provided for information only.
Hydrogen — 0.020
A
Titanium balance balance
2. Referenced Documents
A
The percentage of titanium is determined by difference and need not be
2.1 ASTM Standards:
determined or certified.
3
E8 TestMethodsforTensionTestingofMetallicMaterials
3
E112 Test Methods for Determining Average Grain Size
2.3 ISO Standards:
E 120 Test Methods for ChemicalAnalysis of Titanium and
ISO 6982 Metallic Materials Tensile Testing at Ambient
4
Titanium Alloys 8
Temperature
E 1409 Test Method for the Determination of Oxygen in
2.4 American Society for Quality Standard:
Titanium and Titanium Alloys by the Inert Gas Fusion
ASQ C1 Specification of General Requirements for a Qual-
5
9
Technique
ity Program
E 1447 Test Method for the Determination of Hydrogen in
3. Terminology
Titanium and Titanium Alloys by the Inert Gas Fusion
5
Thermal Conductivity Method
3.1 Definitions of Terms Specific to This Standard:
F 748 Practice for Selecting Generic Biological Test Meth-
3.1.1 beta transus, n—the minimum temperature at which
6
ods for Materials and Devices
the alpha plus beta phase can transform to 100 % beta phase.
F 981 Practice for Assessment of Compatibility of Bioma-
4. Product Classification
terials for Surgical Implants with Respect to Effect of
6
Materials on Muscle and Bone 3
4.1 Bar—Rounds or flats from ⁄16 in. (4.76 mm) to 4 in.
F 1408 Practice for Subcutaneous Screening Test for Im-
(101.60 mm) in diameter or thickness (other sizes and shapes
6
plant Materials
by special order).
3
2.2 Aerospace Materials Specification:
4.2 Wire—Rounds or flats less than ⁄16 in. (4.76 mm) in
AMS 2249 Chemical Check Analysis Limits, Titanium and
diameter or thickness.
7
Titanium Alloys
5. Ordering Information
5.1 Include with inquiries and orders for material under this
1
specification shall include the following information:
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of 5.1.1 Quantity,
Subcommittee F0.4.12 on Metallurgical Materials.
5.1.2 ASTM designation and date of issue,
Current edition approved Oct. 10, 2001. Published February 2002.
5.1.3 Form (bar or wire),
2
FDA 510K application number K903630.
3
Annual Book of ASTM Standards, Vol 03.01.
4
Annual Book of ASTM Standards, Vol 03.05.
5 8
Annual Book of ASTM Standards, Vol 03.06. American National Standards Institute, 25 W. 43rd St., 4th Floor, New York,
6
Annual Book of ASTM Standards, Vol 13.01. NY 10036.
7 9
Available from theAmerican Society ofAutomotive Engineers, 400 Common- Available from the American Society for Quality, 600 N. Plankinton Ave.,
wealth Dr., Warrendale, PA 15096-0001. Milwaukee, WI 53203.
*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.
1
---------------------- Page: 1 ----------------------
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn. Contact ASTM
International (www.astm.org) for the latest information.
F1813–01
5.1.4 Condition (see 6.3), 7.2.1 The product analysis is either for the purpose of
5.1.5 Mechanical properties (if applicable for special con- verifying the composition of a heat or lot or to determine
ditions), variations in the composition within the heat.
5.1.6 Finish (see 6.2), 7.2.2 Acceptance or rejection of a heat or manufacturing lot
5.1.7 Applicabledimensionincludingsize,thickness,width, of material may be made by the purchaser on the basis of this
or drawing number, product analysis.
5.1.8 Special tests, if any, 7.3 For reference purposes, use Test Methods E 120,
5.1.9 Other requirements. E 1409, and E 1447 or other analytical methods agreed upon
between purchaser and supplier.
6
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.