ASTM F560-22

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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: F560 − 17 F560 − 22
Standard Specification for
Unalloyed Tantalum for Surgical Implant Applications (UNS
R05200, UNS R05400)
This standard is issued under the fixed designation F560; 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 chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip, bar,
and wire used in the manufacture of surgical implants.
1.2 Units—UnitsThe—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, to ensure conformance with the standard, each system shall be used
independently of the other. Combiningother and values offrom the two systems may result in non-conformance with this
standard.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
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric
SystemMetric Practice
2.2 ISO Standards:
ISO 6892 Metallic Materials– Tensile Metallic Materials—Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems—Requirements
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
ISO 13782 Implants for Surgery—Metallic Materials—Unalloyed Tantalum for Surgical Implant Applications
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
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 Nov. 1, 2017Feb. 15, 2022. Published November 2017February 2022. Originally approved in 1978. Last previous edition approved in 20132017
ɛ1
as F560 – 13F560 – 17. . DOI: 10.1520/F0560-17.10.1520/F0560-22.
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.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.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
F560 − 22
3.1.1 bar—material 3.15 to 63.5 mm [0.125 to 2.5 in.] in diameter in round, hexagonal, or octagonal cross section supplied in
straight lengths.
3.1.2 lot—all material produced from the same ingot or a single powder blend with the same cross section under the same
conditions at essentially the same time.
3.1.3 plate—a flat product more than 4.75 mm [0.1875 in.] in thickness.
3.1.3 bar—material 3.15 to 63.5 mm [0.125 to 2.5 in.] in diameter in round, hexagonal, or octagonal cross section supplied in
straight lengths.
3.1.4 sheet—a flat product 150 mm [6 in.] or more in width and from 0.13 to 4.75 mm [0.005 to 0.1875 in.] in thickness.
3.1.5 strip—a flat product less than 150 mm [6 in.] in width and from 0.13 to 4.75 mm [0.005 to 0.1875 in.] in thickness, which
may be supplied in coil.
3.1.6 wire—material up to 3.15 mm [0.124 in.] in diameter furnished in coils or on spools or reels.
4. Ordering Information
4.1 Inquiries and orders under this specification shall include the following information:
4.1.1 Quantity (weight or number of pieces);
4.1.2 ASTM designation, alloy number, and date of issue;
4.1.3 Units to be used for certification (SI or inch-pound);
4.1.4 Composition designation (see 5.1);
4.1.5 Form (strip, sheet, plate, bar, wire) (see 3.1);
4.1.6 Condition (see 5.4);
4.1.7 Applicable dimensions, including size, thickness, width, and length (random, exact, multiples), or drawing number;
4.1.8 Special tests;
4.1.9 Special requirements; and
4.1.10 Mechanical properties (if applicable for special conditions) (see 7.1).
5. Materials and Manufacture
5.1 Material covered by this specification shall be made from vacuum-arc melted or electron-beam melted ingots (R05200) or
powder-metallurgy consolidated (R05400) unalloyed tantalum.
5.2 The various tantalum mill products covered by this specification are formed with the conventional extrusion, forming,
swaging, rolling, and drawing equipment normally available in metalworking plants.
5.3 Finish—The mill product may be furnished as descaled or pickled, abrasive blasted, chemically milled, ground, machined,
peeled, polished, or as specified by the purchaser.
5.4 Condition:Condition:
F560 − 22
5.4.1 Flat mill products shall be supplied in the cold-worked, cold-worked and stress-relievedstress-relieved, or annealed
condition.
5.4.2 Bar and wire products shall be supplied in the annealed or cold-worked condition.
6. Chemical Requirements
6.1 The material shall conform to the chemical composition requirements in Table 1.
6.1.1 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 certify compliance with this specification.
6.1.2 All commercial metals contain small amounts of elements other than those that are specified. It is neither practical nor
necessary to specify limits for unspecified elements, whether residual elements or trace elements, that can be present. The producer
is permitted to analyze for unspecified elements and is permitted to report such analyses. The presence of an unspecified element
and the reporting of an analysis for that element shall not be a basis for rejection.
6.1.3 Intentional elemental additions other than those specified in Table 1 are not permitted permitted.
6.2 The ingot analysis shall be considered the chemical analysis for products supplied under this specification.
6.3 When requested by the purchaser at the time of purchase, the supplier shall furnish a report certifying the values of carbon,
oxygen, nitrogen, and hydrogen as specified in Table 2 for each lot of material supplied.
TABLE 2 Additional Chemical Requirements for Finished Product
(When Specified by the Purchaser)
Compositions, Maximum % (mass/mass)
Element
A B
R05200 R05400
Carbon 0.020 0.020
Oxygen 0.025 0.035
Nitrogen 0.010 0.010
Hydrogen 0.0015 0.0015
A
Electron-beam or vacuum-arc cast Tantalum.tantalum.
B
Sintered Tantalum.tantalum.
TABLE 1 Chemical Requirements
Compositions, max % (mass/mass)
Element
A B
R05200 R05400
Carbon 0.010 0.010
Oxygen 0.015 0.030
Nitrogen 0.010 0.010
Hydrogen 0.0015 0.0015
Niobium 0.10 0.10
Iron 0.010 0.010
Titanium 0.010 0.010
Tungsten 0.050 0.050
Molybdenum 0.020 0.020
Silicon 0.005 0.005
Nickel 0.010 0.010
Cobalt <0.1 <0.1
C C
Tantalum balance balance
A
Electron-beam or vacuum-arc cast Tantalum.tantalum.
B
Sintered Tantalum.tantalum.
C
Assumed Approximately equal to the difference of 100 % and the sum percent-
age of the other specified elements. The percentage of the Tantalumtantalum
difference is not required to be reported.
F560 − 22
7. Mechanical Properties
7.1 The material supplied under this specification shall conform to the mechanical property requirements in Tables 3 and 4.
Mechanical properties for material in conditions other than those included in Tables 3 and 4 shall be specified by the purchaser.
7.2 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 0.0760.003 to 0.178 mm/mm/min [0.003 to 0.007 in./in./min] 0.007 mm/mm/min [in./in./min]
through yield and then the crosshead speed may be increased so as to produce fracture in approximately one additional minute.
7.3 Number of Tests:
7.3.1 Bar and Wire—Perform at least one tension for each lot. Should any of these test pieces not meet the specified requirements,
test two additional test pieces representative of the same lot, in the same manner, for each failed test piece. The lot shall be
considered in compliance only if all additional test pieces meet the specified requirements.
7.3.2 Tensile test results for which any specimen fractures outside the gage length shall be considered acceptable if both the
elongation and reduction of area meet meets the minimum requirements specified. Refer to Test MethodMethods E8/E8M,
sectionssubsections 7.11.4 and 7.11.5.
7.3.3 If either the elongation or the reduction of area is less than the minimum requirement, discard the test and retest. Retest one
specimen for each specimen that did not meet the minimum requirements.
7.3.4 Sheet,
...