ASTM F1813-06
(Specification)Standard Specification for Wrought Titanium–12 Molybdenum–6 Zirconium–2 Iron Alloy for Surgical Implant (UNS R58120)
Standard Specification for Wrought Titanium<span class='unicode'>–</span>12 Molybdenum<span class='unicode'>–</span>6 Zirconium<span class='unicode'>–</span>2 Iron Alloy for Surgical Implant (UNS R58120)
ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-12 molybdenum- 6 zirconium-2 iron alloy for surgical implants to be used in the manufacture of surgical implants. The heat analysis shall conform to the chemical composition requirements prescribed. Ingot analysis may be used for reporting all chemical requirements, except hydrogen. The wrought titanium-12 molybdenum-6 zirconium-2 iron alloy are classified as bar, forging bar and wire. The ultimate tensile strength, yield strength, elongation, and area reduction of the material shall be tested to meet the requirements prescribed.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium–12 molybdenum–6 zirconium–2 iron alloy for surgical implants 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 for information only.
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Designation:F1813 −06
StandardSpecification for
Wrought Titanium–12 Molybdenum–6 Zirconium–2 Iron Alloy
1
for Surgical Implant (UNS R58120)
This standard is issued under the fixed designation F1813; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* 2.3 ISO Standards:
ISO 6982Metallic Materials Tensile Testing at Ambient
1.1 This specification covers the chemical, mechanical, and
5
Temperature
metallurgical requirements for wrought titanium–12 molybde-
5
ISO 9001Quality Management Standard
num–6 zirconium–2 iron alloy for surgical implants to be used
2 2.4 American Society for Quality Standard:
in the manufacture of surgical implants.
ASQ C1Specification of General Requirements for a Qual-
6
1.2 The values stated in inch pound units are to be regarded
ity Program
as the standard. The SI equivalents in parentheses are for
3. Terminology
information only.
3.1 Definitions of Terms Specific to This Standard:
2. Referenced Documents
3.1.1 beta transus, n—the minimum temperature at which
3
the alpha plus beta phase can transform to 100% beta phase.
2.1 ASTM Standards:
3.1.2 lot, n—the total number of mill products produced
E8Test Methods for Tension Testing of Metallic Materials
from the same melt heat under the same conditions at essen-
E29Practice for Using Significant Digits in Test Data to
tially the same time.
Determine Conformance with Specifications
E112Test Methods for Determining Average Grain Size
4. Product Classification
E1409TestMethodforDeterminationofOxygenandNitro-
gen in Titanium and Titanium Alloys by the Inert Gas
4.1 Bar—Rounds,flatsorothershapesfrom0.1875in.(4.76
Fusion Technique
mm) to 4 in. (101.60 mm) in diameter or thickness. (Other
E1447Test Method for Determination of Hydrogen in Tita-
sizes and shapes by special order.)
nium and Titanium Alloys by Inert Gas Fusion Thermal
4.2 Forging Bar—Bar as described in 4.1 used in the
Conductivity/Infrared Detection Method
productionofforgings.Thisproductmaybefurnishedintheas
E2371Test Method for Analysis of Titanium and Titanium
rolled condition.
Alloys by Atomic Emission Plasma Spectrometry
3
4.3 Wire—Rounds, flats or other shapes less than ⁄16 in.
F748PracticeforSelectingGenericBiologicalTestMethods
(4.76 mm) in diameter or thickness.
for Materials and Devices
2.2 Aerospace Materials Specification:
5. Ordering Information
AMS 2249Chemical Check Analysis Limits, Titanium and
4 5.1 Include with inquiries and orders for material under this
Titanium Alloys
specification the following information:
5.1.1 Quantity,
5.1.2 ASTM designation and date of issue,
1
This specification is under the jurisdiction of ASTM Committee F04 on
5.1.3 Form (strip, sheet, plate, bar, forging bar or wire),
Medical and Surgical Materials and Devices and is the direct responsibility of
5.1.4 Condition (see 6.3),
Subcommittee F04.12 on Metallurgical Materials.
5.1.5 Mechanical properties (if applicable for special
Current edition approved Dec. 1, 2006. Published January 2007. Originally
approved in 1997. Last previous edition approved in 2001 as F1813–01. DOI:
conditions),
10.1520/F1813-06.
5.1.6 Finish (see 6.2),
2
FDA 510K application number K903630.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
5
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
4 6
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Available fromAmerican Society for Quality (ASQ), 600 N. PlankintonAve.,
Dr., Warrendale, PA 15096-0001, http://www.sae.org. Milwaukee, WI 53203, http://www.asq.org.
*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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F1813−06
A
TABLE 2 Product Analysis Tolerances
5.1.7 Applicable dimensions including size, thickness,
Tolerance Under the
width, length or drawing number,
Element Minimum or Over the
5.1.8 Special tests, if any, and
B
Maximum Limit
5.1.9 Other requirements.
Nitrogen 0.02
Carbon 0.002
Hydrogen 0.0002
6. Materials and Manufacture
Iron 0.20
Molybdenum 0.25
6.1 The various titanium mill products covered in this
Zirconium over 4 to 6 %, inclusive 0.20
specification normally are formed with the conventional forg-
Zirconium over 4 to 6 %, inclusive 0.30
ing and rolling equipment found in prim
...
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