ASTM F2384-10
(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 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.
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Designation:F2384 −10
StandardSpecification for
Wrought Zirconium-2.5Niobium Alloy for Surgical Implant
1
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).
4
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.
3
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),
1
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 Dec. 1, 2010. Published December 2010. Originally
5.1.8 Finish (see 6.2),
approved in 2005. Last previous edition approved in 2005 as F2384 – 05. DOI:
5.1.9 Applicabledimensionincludingsize,thickness,width,
10.1520/F2384-10.
or drawing number,
2
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
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
4
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
1
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F2384−10
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 purch
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2384–05 Designation: F2384 – 10
Standard Specification for
Wrought Zirconium-2.5Niobium Alloy for Surgical Implant
1
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
1.1 Thisspecificationcoversthechemical,mechanical,andmetallurgicalrequirementsforwroughtzirconium-2.5niobiumalloy
2
to be used in the manufacture of surgical implants (1).
1.2The values stated in inch-pound units are to be regarded as the standard. The SI equivalents in parentheses may be
approximate.
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.
2. Referenced Documents
3
2.1 ASTM Standards:
B550/B550M Specification for Zirconium and Zirconium Alloy Bar and Wire
E88/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
E1552 Test Method for Determining Hafnium in Zirconium and ZirconiumAlloys By Direct Current PlasmaAtomic Emission
Spectrometry
E1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys
E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals
F67 Specification for UnalloyedTitanium, for Surgical ImplantApplications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices Practice for Selecting Generic
Biological Test Methods for Materials and Devices
SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
4
2.2 ISO Standard:
ISO 6829Metallic Materials Tensile Testing at Ambient Temperature
2.3 American Society for Quality Standard:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
ASQ C1Specification of General Requirements for a Quality Program ISO 9001 Quality Management Systems—Requirements
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 annealed, adj—material that exhibits a recrystalized grain structure.
3.1.2 lot, n—the total number of mill products produced from the same melt heat under the same conditions at essentially the
same time.
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 Jan. 1, 2005. Published January 2005. DOI: 10.1520/F2384-05.
Current edition approved Dec. 1, 2010. Published December 2010. Originally approved in 2005. Last previous edition approved in 2005 as F2384 – 05. DOI:
10.1520/F2384-10.
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
3
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F2384 – 10
4. Product Classification
4.1 bar—rounds, flats or shapes from 0.18754.76 to 4 in. (4.76101.60 mm [0.1875 to 101.60 mm)4 in.] in diameter or thickness
(other sizes and shapes by special order).
4.2 wire—rounds or flats less than 0.1875 in. (4.76 mm)4.76 mm [0.1875 in.] 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,
5.1.3Grade (if applicable),
5.1.4Form (bar, or wire),
5.1.5Condition (see
5.1.3 Units to be certified—SI or inch-pound,
5.1.4 Grade (if applicable),
5.1.5 Form (bar, or wire),
5.1.6 Condition (see 6.3),
5.1.67 Mechanical propertie
...
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