ASTM F1813-21

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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
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-
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
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)
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
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.
FDA 510K application number K903630.
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.
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
F1813 − 21
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
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, flats, or other shapes from 0.188 in. [4.76 mm] [4.76 mm] to 4.0 in. [102 mm] in diameter or thickness. (Other
sizes and shapes by special order.)
4.2 Forging Bar—Bar as described in 4.1 used in the production of forgings. This product may be furnished in the hot worked
condition.
4.3 Wire—Rounds, flats, or other shapes less than 0.188 in. [4.76 mm] in diameter or thickness.
5. Ordering Information
5.1 Include with inquiries and orders for material under this specification the following information:
5.1.1 Quantity,
5.1.2 ASTM designation and date of issue,
5.1.3 Form (strip, sheet, plate, bar, forging bar, or wire),
5.1.4 Condition (see 6.2),
5.1.5 Mechanical properties (if applicable for special conditions),
5.1.6 Finish (see 6.1),
5.1.7 Applicable dimensions including size, thickness, width, length, or drawing number,
5.1.8 Special tests,tests (if any), and
5.1.9 Other requirements.
6. Materials and Manufacture
6.1 Finish—The mill product may be supplied as specified by the purchaser with a descaled or pickled, abrasive blasted,
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
F1813 − 21
chemically milled, ground, machined, peeled, or polished finish. On billets, bars, plates, and forgings, it is permissible to remove
minor surface imperfections by grinding if the resultant area meets the dimensional and surface finish requirements of this
specification.
6.2 Condition—Material shall be furnished in the solution annealed or hot worked condition.
7. Chemical Requirements
7.1 The heat analysis shall conform to the chemical composition of Table 1. Ingot analysis may be used for reporting all chemical
requirements, except hydrogen. Samples for hydrogen shall be taken from the finished mill product. The supplier shall not ship
material with chemistry outside the requirements specified in Table 1.
7.1.1 Requirements for the major and minor elemental constituents are listed in Table 1. Also listed are important residual
elements. Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.
7.2 Product Analysis: (Check) Analysis—The product analysis tolerances shall conform to the product tolerances in Table 2 per
AMS 2249. Product analysis tolerances do not broaden the specified heat (ladle or ingot) analysis requirements, but cover
variations between laboratories in the measurement of chemical content.
7.2.1 Product (check) analysis tolerances do not broaden the specified heat analysis requirements but cover variations in the
measurement of chemical content between laboratories. The product analysis tolerances shall conform to the product
toleranceslimits are not for producer’s use at producer’s acceptance testing. Product analysis limits are not permitted to be applied
to ladle or ingot analysis. The supplier shall not ship material that is outside the limits specified in Table 21.
7.2.2 TheA product analysis is (check) analysis is one performed by the purchaser or supplier of the metal after it has been worked
into semi-finished or finished forms or fabricated into parts, and is either for the purpose of verifying the composition of a heat
or lot or to determine variations in the composition within the heat. In the analysis of finished parts, these values do not apply to
elements whose percentage can be varied by fabrication techniques employed (for example, oxygen, nitrogen, hydrogen) unless
the sample is sufficiently large to produce a reliable result, either for the purpose of verifying the composition of a heat or
manufacturing lot or to determine variations in the composition within the heat.
7.2.3 Acceptance or rejection of a heat or manufacturing lot of material may be made by the purchaser on the basis of this product
analysis. Product analysis outside the tolerance limits allowed in Table 2 are cause for rejection of the product. A referee analysis
may be used if agreed upon by the supplier and purchaser.
7.2.4 For referee purposes, use Test Methods E2371, E1409, E1941, E2626, and E1447 or other analytical methods agreed upon
between the purchaser and the supplier.
7.3 Samples for chemicalproduct analysis shall be representative of the material being tested. The utmost care must be used in
sampling titanium for chemical analysis because of its affinity for ability to react with elements such as oxygen, nitrogen, and
hydrogen. In Therefore, when cutting samples for analysis, therefore, the operation should be carried out insofar as possible in a
dust-free atmosphere. Cutting tools should be clean and sharp. Samples for analysis should be stored in suitable containers.
TABLE 1 Chemical Requirements
Composition % mass/mass
Element
Min Max
Nitrogen — 0.05
Carbon — 0.05
Hydrogen — 0.020
Iron 1.5 2.5
Oxygen 0.008 0.28
Molybdenum 10.0 13.0
Zirconium 5.0 7.0
A
Titanium Balance
A
The percentage of titanium is determined by difference and need not be
determined or certified.
F1813 − 21
A
TABLE 2 Product Analysis Tolerances
Tolerance Under the
Element Minimum or Over the
B
Maximum Limit
Nitrogen 0.02
Carbon 0.002
Hydrogen 0.0002
Iron 0.20
Molybdenum 0.25
Zirconium over 4 to 6 %, inclusive 0.20
Zirconium over 4 to 6 %, inclusive 0.30
Oxygen up to 0.2 % 0.02
Oxygen over to 0.2 % 0.03
A
Refer to AMS 2249.
B
Under the minimum limit not applicable for elements where only a maximum
percentage is indicated.
8. Mechanical Requirements
8.1 The material supplied under this specification shall conform to the mechanical property requirements in Table 3. Alternative
properties may be agreed upon between the purchaser and supplier.
8.2 Specimens for tension tests shall be prepared and tested in accordance with Test Methods E8/E8M. Tensile properties shall
be determined using a strain rate of 0.003 to 0.007 in./in./min [mm/mm/min] through yield and then the crosshead speed may be
increased so as to produce fracture in approximately one additional minute.
8.2.1 Bar, Forging Bar, and Wire—Test according to Test Methods E8/E8M. Perform at least one tension test from each lot in the
longitudinal direction.
8.2.2 Tensile teststest results for which any specimen fractures outside the gauge length shall be considered valid, if both the
elongation and reduction of area meet the minimum requirements specified. If either the elongation or reduction of area is less than
the minimum requirement, invalidate the specimen and retest. Retest one specimen for each invalidated specimen.
8.2.3 Should any test specimen not meet the specified requirements (except as noted in 8.2.2), test two additional test pieces
representative o
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