ASTM F2384-05
(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).
1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents in parentheses may be approximate.
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Designation: F2384 – 05
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 3. Terminology
3.1 Definitions of Terms Specific to This Standard:
1.1 This specification covers the chemical, mechanical, and
metallurgical requirements for wrought zirconium-2.5niobium 3.1.1 annealed, adj—material that exhibits a recrystalized
alloy to be used in the manufacture of surgical implants (1). grain structure.
1.2 The values stated in inch-pound units are to be regarded 3.1.2 lot, n—the total number of mill products produced
as the standard. The SI equivalents in parentheses may be from the same melt heat under the same conditions at essen-
approximate. tially the same time.
2. Referenced Documents 4. Product Classification
2.1 ASTM Standards: 4.1 bar—rounds, flats or shapes from 0.1875 to 4 in. (4.76
B550/B550M Specification for Zirconium and Zirconium to 101.60 mm) in diameter or thickness (other sizes and shapes
Alloy Bar and Wire by special order).
E8 Test Methods for Tension Testing of Metallic Materials 4.2 wire—rounds or flats less than 0.1875 in. (4.76 mm) in
E29 Practice for Using Significant Digits in Test Data to diameter or thickness.
Determine Conformance with Specifications
5. Ordering Information
E112 Test Methods for Determining Average Grain Size
E1552 Test Method for Determining Hafnium in Zirconium 5.1 Include with inquiries and orders for material under this
specification the following information:
and ZirconiumAlloys By Direct Current Plasma—Atomic
Emission Spectrometry 5.1.1 Quantity,
5.1.2 ASTM designation and date of issue,
F67 Specification for Unalloyed Titanium, for Surgical
Implant Applications (UNS R50250, UNS R50400, UNS 5.1.3 Grade (if applicable),
R50550, UNS R50700) 5.1.4 Form (bar, or wire),
5.1.5 Condition (see 6.3),
F748 Practice for Selecting Generic Biological Test Meth-
ods for Materials and Devices 5.1.6 Mechanical properties (if applicable for special con-
ditions),
2.2 ISO Standard:
ISO 6829 Metallic Materials Tensile Testing at Ambient 5.1.7 Finish (see 6.2),
5.1.8 Applicabledimensionincludingsize,thickness,width,
Temperature
2.3 American Society for Quality Standard: or drawing number,
5.1.9 Special tests, if any, and
ASQ C1 Specification of General Requirements for a Qual-
ity Program 5.1.10 Other requirements.
6. Materials and Manufacture
This specification is under the jurisdiction of ASTM Committee F04 on
6.1 Materials covered by this specification shall be pro-
Medical and Surgical Materials and Devices and is the direct responsibility of
duced by multiple vacuum melting in arc furnaces, electron
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Jan. 1, 2005. Published January 2005. DOI: 10.1520/
beam melting, or other melting processes conventionally used
F2384-05.
for reactive metals.
The boldface numbers in parentheses refer to the list of references at the end of
6.2 Finish—The mill product may be furnished to the
this standard.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or implant manufacturer as descaled or pickled, abrasively
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
blasted, chemically milled, ground, machined, peeled, pol-
Standards volume information, refer to the standard’s Document Summary page on
ished, or as specified by the purchaser.
the ASTM website.
6.3 Condition—Barstock shall be furnished in the annealed
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036.
condition unless otherwise specified.
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Milwaukee, WI 53203.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2384 – 05
TABLE 2 Product Analysis Tolerances
7. Chemical Requirements
Permissible Variation from
7.1 The heat analysis shall conform to the chemical com-
Alloying Element the Specified Range,
positionofTable1.Ingotanalysismaybeusedforreportingall
% mass/mass
chemical requirements, except hydrogen, oxygen, and nitro-
Niobium 0.050
gen. Samples for hydrogen, oxygen and nitrogen shall be taken
Oxygen 0.020
Carbon 0.002
from the finished mill product. The supplier shall not ship
Chromium 0.002
material with chemistry outside the requirements specified in
Hafnium 0.002
Table 1.
Hydrogen 0.0005
Iron 0.002
7.1.1 Requirements for the major and minor elemental
Nitrogen 0.0016
constituents are listed in Table 1. Also listed are important
Tin 0.001
residual elements.Analysis for elements not listed inTable 1 is
not required to verify compliance with this specification.
A
7.2 Product Analysis:
TABLE 3 Mechanical Properties
B
7.2.1 Product analysis tolerances do not broaden the speci-
Yield Strength Elongation in
Tensile Strength,
fied heat analysis requirements but cover variations between Condition (0.2 % offset), 2 in. or 4D or 4W,
min, psi (MPa)
min, psi (MPa) min, %
laboratories in the measurement of chemical content. The
Annealed 65 000 (450) 45 000 (310) 15
product analysis tolerances shall conform to the product
A
tolerances in Table 2. Mechanical properties for conditions other than those listed in this table may
be established by agreement between the supplier and the implant manufacturer.
7.2.2 The product analysis is either for the purpose of
B
Elongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width
verifying the composition of a heat or manufacturing lot, or to
(W) shall be measured using a gage length of 2 in. or 4D or 4W. The gage length
must be reported with the test results. The method for determining elongation of
determine variations in the composition within the heat.
material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated.
7.2.3 Acceptance or rejection of a heat or manufacturing lot
Alternately, a gage length corresponding to ISO 6892 may be used when agreed
of material may be made by the purchaser on the basis of this
upon by supplier and purchaser. (5.65 =So, where So is the original cross
sectional area).
product analysis.
7.3 For referee purposes, use Test Method E1552 or other
analytical methods, or both, as agreed upon between the
purchaser and the supplier. 8.3 Number of Tests—Perform a minimum of two tension
7.4 The samples for chemical analysis shall be representa-
tests from each lot (see 3.1.2). Should either of the two test
tive of the material being tested. The utmost care must be used
specimens not meet the specified requirements, test two addi-
in sampling zirconium for chemical analysis because of its
tional test pieces representative of the same lot in the same
affinity for elements such as oxygen, nitrogen, and hydrogen.
manner. The lot will be considered in co
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