ASTM F1813-21

Standard Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron 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-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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 14-Aug-2021
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F1813 −21
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* toryandReactiveMetalsandTheirAlloysbyCombustion
Analysis
1.1 This specification covers the chemical, mechanical, and
E2371Test Method for Analysis of Titanium and Titanium
metallurgical requirements for wrought titanium-
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
12molybdenum-6zirconium-2iron alloy mill products to be
2 Plasma Atomic Emission Spectrometry (Performance-
used in the manufacture of surgical implants.
Based Test Methodology)
1.2 The values stated in either SI units or inch-pound units
E2626Guide for Spectrometric Analysis of Reactive and
4
are to be regarded separately as standard. The values stated in
Refractory Metals (Withdrawn 2017)
eachsystemarenotnecessarilyexactequivalents;therefore,to
F748PracticeforSelectingGenericBiologicalTestMethods
ensure conformance with the standard, each system shall be
for Materials and Devices
used independently of the other, and values from the two
IEEE/ASTM SI 10American National Standard for Metric
systems shall not be combined.
Practice
5
1.3 This international standard was developed in accor-
2.2 Aerospace Materials Specifications:
dance with internationally recognized principles on standard-
AMS 2249Chemical Check Analysis Limits, Titanium and
ization established in the Decision on Principles for the
Titanium Alloys
Development of International Standards, Guides and Recom-
AMS 2631Ultrasonic Inspection—Titanium and Titanium
mendations issued by the World Trade Organization Technical
Alloy Bar, Billet and Plate
Barriers to Trade (TBT) Committee.
AMS 2380Approval and Control of Premium-Quality Tita-
nium Alloys
2. Referenced Documents
6
2.3 ISO Standards:
3
2.1 ASTM Standards:
ISO 6982Metallic Materials Tensile Testing at Ambient
E8/E8MTest Methods for Tension Testing of Metallic Ma-
Temperature
terials
ISO 9001Quality Management Standard
E29Practice for Using Significant Digits in Test Data to
3. Terminology
Determine Conformance with Specifications
E112Test Methods for Determining Average Grain Size
3.1 Definitions of Terms Specific to This Standard:
E1409TestMethodforDeterminationofOxygenandNitro-
3.1.1 beta transus, n—the minimum temperature at which
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
the alpha plus beta phase can transform to 100% beta phase.
E1447Test Method for Determination of Hydrogen in Tita-
3.1.2 hot work, n—any mechanical deformation process
nium and Titanium Alloys by Inert Gas Fusion Thermal
performed above the recrystallization temperature.
Conductivity/Infrared Detection Method
3.1.3 lot, n—the total number of mill products produced
E1941Test Method for Determination of Carbon in Refrac-
from the same melt heat under the same conditions at essen-
tially the same time.
1
This specification is under the jurisdiction of ASTM Committee F04 on
3.1.4 solution anneal, v—to heat treat in order to remove
Medical and Surgical Materials and Devices and is the direct responsibility of
precipitates.
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Aug. 15, 2021. Published August 2021. Originally
approved in 1997. Last previous edition approved in 2013 as F1813–13. DOI:
4
10.1520/F1813-21. 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 [e-mail]. 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 ----------------------
F1813−21
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,
...

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 − 13 F1813 − 21
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. 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-12molybdenum-
2
6zirconium-2iron alloy mill products to be used in the manufacture of surgical implants.
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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used
independently of the other, and values from the two systems shall not be combined.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
3
2.1 ASTM Standards:
E8/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 Inert Gas Fusion
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
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Direct Current Plasma and Inductively Coupled Plasma
Atomic Emission Spectrometry (Performance-Based Test Methodology)
4
E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals (Withdrawn 2017)
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
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 March 1, 2013Aug. 15, 2021. Published April 2013August 2021. Originally approved in 1997. Last previous edition approved in 20062013 as
F1813 – 06.F1813 – 13. DOI: 10.1520/F1813-13.10.1520/F1813-21.
2
FDA 510K application number K903630.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. 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.
*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 − 21
5
2.2 Aerospace Materials Specification:Specifications:
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
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 essentially the same
time.
3.1.4 solution anneal, v—to heat treat in order to remove precipitates.
4. Product Classification
4.1 Bar—Rounds, fla
...