ASTM F2384-10(2016)
(Specification)Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)
Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)
ABSTRACT
This specification covers the requirements fro wrought zirconium-2.5niobium alloy for use in surgical implant applications. The material shall be manufactured into bars or wires by multiple vacuum melting in arc furnaces, by electron beam melting, or by other melting processes conventionally used for reactive metals. The material shall be in the annealed condition, with the surface descaled or pickled, abrasively blasted, chemically milled, ground, machined, peeled, or polished. Heat and product analyses and tests for tensile strength, yield strength, and elongation shall be performed and shall conform to the requirements specified. In addition, the material shall have a microstructure consisting of a fine dispersion of the alpha and beta phases as a result of processing in the alpha plus beta field, with no coarse, elongated alpha platelets.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought zirconium-2.5niobium alloy to be used in the manufacture of surgical implants (1).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.
General Information
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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:F2384 −10 (Reapproved 2016)
Standard Specification for
Wrought Zirconium-2.5Niobium Alloy for Surgical Implant
Applications (UNS R60901)
This standard is issued under the fixed designation F2384; 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 F748 PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
1.1 This specification covers the chemical, mechanical, and
SI 10 American National Standard for Use of the Interna-
metallurgical requirements for wrought zirconium-2.5niobium
2 tional System of Units (SI): The Modern Metric System
alloy to be used in the manufacture of surgical implants (1).
2.2 ISO Standard:
1.2 The values stated in either SI units or inch-pound units
ISO 6892 Metallic Materials Tensile Testing at Ambient
are to be regarded separately as standard. The values stated in
Temperature
each system may not be exact equivalents; therefore, each
ISO 9001 Quality Management Systems—Requirements
system shall be used independently of the other. Combining
values from the two systems may result in non-conformance 3. Terminology
with the standard.
3.1 Definitions of Terms Specific to This Standard:
3.1.1 annealed, adj—material that exhibits a recrystalized
2. Referenced Documents
grain structure.
2.1 ASTM Standards:
3.1.2 lot, n—the total number of mill products produced
B550/B550M Specification for Zirconium and Zirconium
from the same melt heat under the same conditions at essen-
Alloy Bar and Wire
tially the same time.
E8/E8M Test Methods for Tension Testing of Metallic Ma-
terials
4. Product Classification
E29 Practice for Using Significant Digits in Test Data to
4.1 bar—rounds, flats or shapes from 4.76 to 101.60 mm
Determine Conformance with Specifications
[0.1875 to 4 in.] in diameter or thickness (other sizes and
E112 Test Methods for Determining Average Grain Size
shapes by special order).
E1552 Test Method for Determining Hafnium in Zirconium
4.2 wire—rounds or flats less than 4.76 mm [0.1875 in.] in
andZirconiumAlloysByDirectCurrentPlasma—Atomic
diameter or thickness.
Emission Spectrometry
E1941 Test Method for Determination of Carbon in Refrac-
5. Ordering Information
tory and Reactive Metals andTheirAlloys by Combustion
Analysis 5.1 Include with inquiries and orders for material under this
E2626 Guide for Spectrometric Analysis of Reactive and specification the following information:
Refractory Metals 5.1.1 Quantity,
F67 Specification for Unalloyed Titanium, for Surgical Im- 5.1.2 ASTM designation and date of issue,
plant Applications (UNS R50250, UNS R50400, UNS 5.1.3 Units to be certified—SI or inch-pound,
R50550, UNS R50700) 5.1.4 Grade (if applicable),
5.1.5 Form (bar, or wire),
5.1.6 Condition (see 6.3),
This specification is under the jurisdiction of ASTM Committee F04 on
5.1.7 Mechanical properties (if applicable for special
Medical and Surgical Materials and Devices and is the direct responsibility of
conditions),
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved April 1, 2016. Published June 2016. Originally
5.1.8 Finish (see 6.2),
approved in 2005. Last previous edition approved in 2010 as F2384 – 10. DOI:
5.1.9 Applicabledimensionincludingsize,thickness,width,
10.1520/F2384-10R16.
or drawing number,
The boldface numbers in parentheses refer to the list of references at the end of
this standard. 5.1.10 Special tests, if any, and
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 Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2384−10 (2016)
TABLE 2 Product Analysis Tolerances
5.1.11 Other requirements.
Permissible Variation from
Alloying Element the Specified Range,
6. Materials and Manufacture
% mass/mass
6.1 Materials covered by this specification shall be pro-
Niobium 0.050
duced by multiple vacuum melting in arc furnaces, electron
Oxygen 0.020
Carbon 0.002
beam melting, or other melting processes conventionally used
Chromium 0.002
for reactive metals.
Hafnium 0.002
Hydrogen 0.0005
6.2 Finish—The mill product may be furnished to the
Iron 0.002
implant manufacturer as descaled or pickled, abrasively
Nitrogen 0.0016
blasted, chemically milled, ground, machined, peeled, Tin 0.001
polished, or as specified by the purchaser.
6.3 Condition—Barstock shall be furnished in the annealed
condition unless otherwise specified.
7.4 The samples for chemical analysis shall be representa-
tive of the material being tested. The utmost care must be used
7. Chemical Requirements
in sampling zirconium for chemical analysis because of its
7.1 The heat analysis shall conform to the chemical com-
affinity for elements such as oxygen, nitrogen, and hydrogen.
positionofTable1.Ingotanalysismaybeusedforreportingall
In cutting samples for analysis, therefore, the operation should
chemical requirements, except hydrogen, oxygen, and nitro-
be carried out insofar as possible in a dust-free atmosphere.
gen. Samples for hydrogen, oxygen and nitrogen shall be taken
Cutting tools should be clean and sharp. Samples for analysis
from the finished mill product. The supplier shall not ship
should be stored in suitable containers.
material with chemistry outside the requirements specified in
Table 1. Guide E2626 may be used as a guide for chemical 8. Mechanical Requirements
analysis techniques.
8.1 The material supplied under this specification shall
7.1.1 Requirements for the major and minor elemental
conform to the mechanical property requirements in Table 3.
constituents are listed in Table 1. Also listed are important
8.2 Specimens for tension tests shall be machined from bar
residual elements.Analysis for elements not listed in Table 1 is
in the longitudinal direction and tested in accordance with Test
not required to verify compliance with this specification.
Methods E8/E8M.Tensile properties shall be determined using
7.2 Product Analysis:
a strain rate of 0.003 to 0.007 in./in./min [mm/mm/min]
7.2.1 Product analysis tolerances do not broaden the speci-
through yield and then the crosshead speed may be increased
fied heat analysis requirements but cover variations between
so as to produce fracture in approximately one additional
laboratories in the measurement of chemical content. The
minute.
product analysis tolerances shall conform to the product
8.3 Number of Tests—Perform a minimum of two tension
tolerances in Table 2.
tests from each lot (see 3.1.2). Should either of the two test
7.2.2 The product analysis is either for the purpose of
specimens not meet the specified requirements, test two addi-
verifying the composition of a heat or manufacturing lot, or to
tional test pieces representative of the same lot in the same
determine variations in the composition within the heat.
manner. The lot will be considered in compliance only if both
7.2.3 Acceptance or rejection of a heat or manufacturing lot
additional test pieces meet the specified requirements.
of material may be made by the purchaser on the basis of this
product analysis.
8.4 Tension test results for which any specimen fractures
outside the gage length shall be considered acceptable, if both
7.3 Forrefereepurposes,useTestMethodE1552andE1941
the elongation and reduction of area meets the minimum
or other analytical methods, as agreed upon between the
requirements specified. Refer to Test Methods E8/E8M, sec-
purchaser and the supplier.
tions 7.11.4 and 7.11.5. If either the elongation or reduction of
area is less than the minimum requirement, discard the test and
TABLE 1 Chemical Requirements
Composition % mass/mass
Element A
TABLE 3 Mechanical Properties
min max
B
Yield Strength
Niobium 2.40 2.80 Elongation in
Tensile Strength,
Condition (0.2 % offset), 2 in. or 4D or 4W,
Oxygen 0.09 0.13
min, MPa [psi]
min, %
min, MPa [psi]
Carbon { 0.027
Chromium { 0.020
Annealed 450 [65 000] 310 [45 000] 15
Hafnium { 0.010
A
Mechanical properties for conditions other than those listed in this table may be
Hydrogen { 0.002
...
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