ASTM F3273-17(2021)e1
(Specification)Standard Specification for Wrought Molybdenum-47.5 Rhenium Alloy for Surgical Implants (UNS R03700)
Standard Specification for Wrought Molybdenum-47.5 Rhenium Alloy for Surgical Implants (UNS R03700)
ABSTRACT
This specification establishes the chemical, mechanical, and metallurgical requirements for wrought molybdenum-47.5 rhenium alloy to be used in the manufacture of surgical implants. The alloy consists of nominal 47.5 mass percent rhenium balance molybdenum of approximately 99.79% purity and residual plus trace elements. This specification applies to round bars and flats from 1.00 mm (0.0394 in.) to 101.60 mm (4.00 in.) in diameter or thickness (other sizes and shapes by special order), any sheet under 4.76 mm (0.1875 in.) in thickness and 610 mm (24 in.) or more in width, and other forms and shapes as may be agreed upon by the purchaser and supplier. The product may be furnished to the implant manufacturer as mechanically or chemically descaled by pickling, abrasively blasting, chemically milled, ground, machined, peeled, polished, combinations of these operations, or as specified by the purchaser. On billets, bars, plates, and forgings, minor surface imperfections may be removed by grinding or machining if the resultant area meets the dimensional and surface finish requirements of this specification.
Also covered by this specification are ordering information, ultrasonic inspection, significance of numerical limits, certification, and quality program requirements.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought molybdenum-47.5 rhenium alloy to be used in the manufacture of surgical implants.
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary 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 nonconformance with the standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 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
Relations
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.
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Designation:F3273 −17 (Reapproved 2021)
Standard Specification for
Wrought Molybdenum-47.5 Rhenium Alloy for Surgical
Implants (UNS R03700)
This standard is issued under the fixed designation F3273; 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.
ε NOTE—Appendix X2 was updated editorially in November 2021.
1. Scope C1113/C1113M Test Method for Thermal Conductivity of
Refractories by HotWire (Platinum ResistanceThermom-
1.1 This specification covers the chemical, mechanical, and
eter Technique)
metallurgical requirements for wrought molybdenum-47.5 rhe-
E8/E8M Test Methods for Tension Testing of Metallic Ma-
nium alloy to be used in the manufacture of surgical implants.
terials
1.2 The SI units in this standard are the primary units. The
E29 Practice for Using Significant Digits in Test Data to
values stated in either primary SI units or secondary inch-
Determine Conformance with Specifications
pound units are to be regarded separately as standard. The
E228 Test Method for Linear Thermal Expansion of Solid
values stated in each system may not be exact equivalents;
Materials With a Push-Rod Dilatometer
therefore,eachsystemshallbeusedindependentlyoftheother.
E290 Test Methods for Bend Testing of Material for Ductil-
Combining values from the two systems may result in noncon-
ity
formance with the standard.
E1621 Guide for ElementalAnalysis by Wavelength Disper-
1.3 This standard does not purport to address all of the
sive X-Ray Fluorescence Spectrometry
safety concerns, if any, associated with its use. It is the E1941 Test Method for Determination of Carbon in Refrac-
responsibility of the user of this standard to establish appro-
tory andReactive Metals andTheirAlloys byCombustion
priate safety, health, and environmental practices and deter- Analysis
mine the applicability of regulatory limitations prior to use.
E2626 Guide for Spectrometric Analysis of Reactive and
1.4 This international standard was developed in accor- Refractory Metals (Withdrawn 2017)
dance with internationally recognized principles on standard-
IEEE/ASTM SI 10 American National Standard for Metric
ization established in the Decision on Principles for the
Practice
Development of International Standards, Guides and Recom-
2.2 Aerospace Material Specifications:
mendations issued by the World Trade Organization Technical
AMS 2630 Inspection, Ultrasonic Product 0ver 0.5 inch
Barriers to Trade (TBT) Committee.
(12.7 mm) Thick
AMS 2632 Ultrasonic Inspection of Thin Materials
2. Referenced Documents
2.3 ISO Standards:
2.1 ASTM Standards:
ISO 6892-1 Metallic materials—Part 1: Method of test at
B193 Test Method for Resistivity of Electrical Conductor
room temperature
Materials
ISO 9001 Quality management systems requirements
B311 Test Method for Density of Powder Metallurgy (PM)
ISO10993-5 Biologicalevaluationofmedicaldevices—Part
Materials Containing Less Than Two Percent Porosity
5: Tests for in vitro cytotoxicity
B774/B774M Specification for Low Melting Point Alloys
ISO10993-6 Biologicalevaluationofmedicaldevices—Part
and Solders
6: Tests for local effects after implantation
ISO 10993-10 Biological evaluation of medical devices—
This specification is under the jurisdiction of ASTM Committee F04 on
Part 10: Tests for irritation and skin sensitization
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Nov. 15, 2021. Published November 2021. Originally
approved in 2017. Last previous edition approved in 2017 as F3273 – 17. DOI: The last approved version of this historical standard is referenced on
10.1520/F3273-17R21E01. www.astm.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Aerospace Industries Association (AIA), 1000 Wilson Blvd.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Suite 1700, Arlington, VA 22209, http://www.aia-aerospace.org.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F3273−17 (2021)
ISO 10993-11 Biological evaluation of medical devices— 6. Materials and Manufacture
Part 11: Tests for systemic toxicity
6.1 The alloy consists of nominal 47.5 mass % rhenium
balance molybdenum of approximately 99.79 % purity and
3. Terminology
residual plus trace elements.
3.1 Definitions:
6.2 Finish—The product may be furnished to the implant
3.1.1 cold work, n—any mechanical deformation process
manufacturer as mechanically or chemically descaled by
performed below the recrystallization temperature which re-
pickling, abrasively blasting, chemically milled, ground,
sults in strain hardening of the material.
machined, peeled, polished, combinations of these operations,
3.1.2 lot, n—the total number of mill products produced or as specified by the purchaser. On billets, bars, plates, and
from the same melt heat under the same conditions at essen-
forgings, it is permissible to remove minor surface imperfec-
tially the same time. tions by grinding or machining if the resultant area meets the
dimensional and surface finish requirements of this specifica-
4. Product Classification tion.
6.3 Condition—Material shall be furnished in the annealed,
4.1 Bar—Round bars and flats from 1.00 mm (0.0394 in.) to
101.60 mm (4.00 in.) in diameter or thickness (other sizes and cold-worked, or extra hard conditions that result from thermal
or work-hardening operations. Conditions other than those
shapes by special order).
listed in Table 2 may be established between the supplier and
4.2 Sheet—Any product under 4.76 mm (0.1875 in.) in
purchaser.
thickness and 610 mm (24 in.) or more in width.
4.3 Other—Other forms and shapes may be provided by
7. Chemical Requirements
agreement between the purchaser and supplier.
7.1 The heat analysis shall conform to the chemical com-
position specified in Table 1. The supplier shall not ship
5. Ordering Information
material with chemistry outside the requirements specified in
5.1 Include with inquiries and orders for material under this
Table 1.
specification the following information:
7.1.1 Requirements for the major and minor elemental
5.1.1 Quantity;
constituents are listed in Table 1. Also listed are important
5.1.2 ASTM designation and date of issue;
residual elements.Analysis for elements not listed in Table 1 is
5.1.3 Form (bar, sheet);
not required to verify compliance with this specification.
5.1.4 Condition (see 6.3);
7.2 For referee purposes use Guides E1621 and E2626 and
5.1.5 Mechanical properties (if applicable, for special
Test Method E1941, or other analytical method agreed upon
conditions), Table 2;
between the purchaser and the supplier.
5.1.6 Finish (see 6.2);
7.3 Samples for chemical analysis shall be representative of
5.1.7 Applicable dimensions including size, thickness,
the material being tested. The utmost care must be used in
width, length, or drawing number;
sampling for chemical analysis because of its affinity for
5.1.8 Special tests (see 9.1); and
elements such as oxygen, nitrogen, and hydrogen. In cutting
5.1.9 Other requirements.
samples for analysis, therefore, the operation should be carried
out insofar as possible in a dust-free atmosphere. If cutting
tools are to be used they should be clean and sharp; however,
lasercuttingispreferred.Samplesforanalysisshouldbestored
TABLE 1 Chemical Requirements
in suitable containers.
Composition, %
Element
(mass/mass)
8. Mechanical Requirements
Nitrogen, max 0.010
Carbon, max 0.050
8.1 The material supplied under this specification shall
Hydrogen, max 0.010
conform to the mechanical properties given in Table 2.
Iron, max 0.010
Oxygen max 0.010
Alternate properties may be agreed upon between the pur-
Sulfur, max 0.010
chaser and supplier.
Phosphorous, max 0.010
Silicon, max 0.010
8.2 Specimens for tension tests shall be prepared and tested
Boron, max 0.010
in accordance with Test Methods E8/E8M. Tensile properties
Copper, max 0.010
Titanium., max 0.010
shall be determined using a strain rate of 0.003 to 0.007
Tungsten, max 0.050
mm/mm/min (in./in./min) through yield and then the crosshead
Manganese, max 0.010
speed may be increased to produce fracture in approximately
Tin, max 0.010
Rhenium 46.0–49.0
one additional minute.
A
Molybdenum Balance
8.2.1 Bar and Sheet—Test according to Test Methods E8/
A
Approximately equal to the difference between 100 % and the sum percentage
E8M. If one test specimen does not meet the specified
of the other specified elements. The percentage molybdenum content by differ-
requirements, test two additional test pieces representative of
ence is not required to be reported.
the same lot, in the same manner for each test specimen. The
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F3273−17 (2021)
TABLE 2 Mechanical Properties for Bar and Sheet
Ultimate Tensile Strength, min, Yield Strength (0.2 % offset),
A
Condition Form Elongation min, % Reduction of Area, min, %
MPa (psi) min, MPa (psi)
Annealed Bar 760 (110 000) 480 (70 000) 10 12
Cold-Worked Bar 1240 (180 000) 1100 (160 000) 12 40
Extra Hard Bar 1380 (200 000) 1310 (190 000) 10 45
B
Annealed Sheet 860 (125 000) 610 (85 000) 10 —
A
Elongation of material 1.6 mm (0.063 in.) or greater in diameter (D) or thickness (T) shall be measured using a gauge length of 50 mm, 4D or 4W. The gauge length
must be reported with the test results. The method for determining elongation of material under 1.
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