ASTM F1813-21

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 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.
*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
...