ASTM F1813-13
(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)
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-12molybdenum-6zirconium-2iron alloy mill products to be used in the manufacture of surgical implants.2
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.
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Designation:F1813 −13
Standard Specification for
Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for
1
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* E2371Test Method for Analysis of Titanium and Titanium
Alloys by Atomic Emission Plasma Spectrometry (With-
1.1 This specification covers the chemical, mechanical, and
4
drawn 2013)
metallurgical requirements for wrought titanium-
E2626Guide for Spectrometric Analysis of Reactive and
12molybdenum-6zirconium-2iron alloy mill products to be
2 Refractory Metals
used in the manufacture of surgical implants.
F67Specification for Unalloyed Titanium, for Surgical Im-
1.2 The values stated in either SI units or inch-pound units
plant Applications (UNS R50250, UNS R50400, UNS
are to be regarded separately as standard. The values stated in
R50550, UNS R50700)
each system may not be exact equivalents; therefore, each
F748PracticeforSelectingGenericBiologicalTestMethods
system shall be used independently of the other. Combining
for Materials and Devices
values from the two systems may result in non-conformance
IEEE/ASTM SI 10American National Standard for Metric
with the standard.
Practice
5
2.2 Aerospace Materials Specification:
2. Referenced Documents
AMS 2249Chemical Check Analysis Limits, Titanium and
3
2.1 ASTM Standards:
Titanium Alloys
E8/E8MTest Methods for Tension Testing of Metallic Ma-
AMS 2631 Ultrasonic Inspection—Titanium and Titanium
terials
Alloy Bar, Billet and Plate
E29Practice for Using Significant Digits in Test Data to
AMS 2380 Approval and Control of Premium-Quality
Determine Conformance with Specifications
Titanium Alloys
6
E112Test Methods for Determining Average Grain Size
2.3 ISO Standards:
E1409TestMethodforDeterminationofOxygenandNitro-
ISO 6982 Metallic Materials Tensile Testing at Ambient
gen in Titanium and Titanium Alloys by the Inert Gas
Temperature
Fusion Technique
ISO 9001Quality Management Standard
E1447Test Method for Determination of Hydrogen in Tita-
3. Terminology
nium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
3.1 Definitions of Terms Specific to This Standard:
E1941Test Method for Determination of Carbon in Refrac- 3.1.1 beta transus, n—the minimum temperature at which
toryandReactiveMetalsandTheirAlloysbyCombustion
the alpha plus beta phase can transform to 100% beta phase.
Analysis
3.1.2 hot work, n—any mechanical deformation process
performed above the recrystallization temperature.
1
3.1.3 lot, n—the total number of mill products produced
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
from the same melt heat under the same conditions at essen-
Subcommittee F04.12 on Metallurgical Materials.
tially the same time.
Current edition approved March 1, 2013. Published April 2013. Originally
approved in 1997. Last previous edition approved in 2006 as F1813–06. DOI:
4
10.1520/F1813-13. The last approved version of this historical standard is referenced on
2
FDA 510K application number K903630. www.astm.org.
3 5
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Society of Automotive Engineers (SAE), 400 Commonwealth
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Dr., Warrendale, PA 15096-0001, http://www.sae.org.
6
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.
*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 ----------------------
F1813−13
3.1.4 solution anneal, v—to heat treat in order to remove gen shall be taken from the finished mill product.The supplier
precipitates. shallnotshipmaterialwithchemistryoutsidetherequirements
specified in Table 1.
4. Product Classification
7.1.1 Requirements for the major and minor elemental
constituents are listed in Table 1. Also listed are important
4.1 Bar—Rounds, flats or other shapes from 0.188 in. [4.76
residualelements.AnalysisforelementsnotlistedinTable1is
mm] to 4.0 in. [102 mm] in diameter or thickness. (Other sizes
not required to verify compliance with this specification.
and shapes by special order.)
7.2 Product Analysis:
4.2 Forging Bar—Bar as
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1813 − 06 F1813 − 13
Standard Specification for
Wrought Titanium–12 Molybdenum–6 Zirconium–2 Iron
Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical
1
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. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) 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 titanium–12 molybdenum–6
zirconium–2 iron alloy for surgical implants titanium-12molybdenum-6zirconium-2iron alloy mill products to be used in the
2
manufacture of surgical implants.
1.2 The values stated in inch pound units either SI units or inch-pound units are to be regarded separately as the standard. The
SI equivalents in parentheses are for information only.values stated in each system may not be exact equivalents; therefore, each
system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the
standard.
2. Referenced Documents
3
2.1 ASTM Standards:
E8E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E112 Test Methods for Determining Average Grain Size
E1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by the Inert Gas Fusion
Technique
E1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
E1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
4
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Atomic Emission Plasma Spectrometry (Withdrawn 2013)
E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
IEEE/ASTM SI 10 American National Standard for Metric Practice
5
2.2 Aerospace Materials Specification:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 2631 Ultrasonic Inspection—Titanium and Titanium Alloy Bar, Billet and Plate
AMS 2380 Approval and Control of Premium-Quality Titanium Alloys
6
2.3 ISO Standards:
ISO 6982 Metallic Materials Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Standard
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 Dec. 1, 2006March 1, 2013. Published January 2007April 2013. Originally approved in 1997. Last previous edition approved in 20012006 as
F1813 – 01.F1813 – 06. DOI: 10.1520/F1813-06.10.1520/F1813-13.
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
4
The last approved version of this historical standard is referenced on www.astm.org.
5
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
6
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.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
1
---------------------- Page: 1 ----------------------
F1813 − 13
2.4 American Society for Quality Standard:
7
ASQ C1 Specification of General Requirements for a Quality Program
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 beta transus, n—the minimum temperature at which the alpha plus beta phase can transform to 100 % beta phase.
3.1.2 hot work, n—any mechanical deformation process performed above the recrystallization temperature.
3.1.3 lot, n—the total number of mill products produced from the same melt heat under the same conditions at essentiall
...
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