ASTM F560-22

Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

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—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 and values from the two systems 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.

General Information

• Status: Published
• Publication Date: 14-Feb-2022
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

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:F560 −22
Standard Specification for
Unalloyed Tantalum for Surgical Implant Applications (UNS
1
R05200, UNS R05400)
ThisstandardisissuedunderthefixeddesignationF560;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
3
1. Scope* 2.2 ISO Standards:
ISO 6892 Metallic Materials—Tensile Testing at Ambient
1.1 This specification covers chemical, mechanical, and
Temperature
metallurgical requirements for unalloyed tantalum plate, sheet,
ISO 9001 Quality Management Systems—Requirements
strip, bar, and wire used in the manufacture of surgical
ISO 13485 Medical Devices—Quality Management
implants.
Systems—Requirements for Regulatory Purposes
1.2 Units—The values stated in either SI units or inch-
ISO 13782 Implants for Surgery—Metallic Materials—
pound units are to be regarded separately as standard. The
Unalloyed Tantalum for Surgical Implant Applications
values stated in each system may not be exact equivalents;
therefore, to ensure conformance with the standard, each 3. Terminology
system shall be used independently of the other and values
3.1 Definitions of Terms Specific to This Standard:
from the two systems shall not be combined.
3.1.1 bar—material 3.15 to 63.5 mm [0.125 to 2.5 in.] in
1.3 This international standard was developed in accor-
diameter in round, hexagonal, or octagonal cross section
dance with internationally recognized principles on standard-
supplied in straight lengths.
ization established in the Decision on Principles for the
3.1.2 lot—all material produced from the same ingot or a
Development of International Standards, Guides and Recom-
single powder blend with the same cross section under the
mendations issued by the World Trade Organization Technical
same conditions at essentially the same time.
Barriers to Trade (TBT) Committee.
3.1.3 plate—a flat product more than 4.75 mm [0.1875 in.]
in thickness.
2. Referenced Documents
2
3.1.4 sheet—a flat product 150 mm [6 in.] or more in width
2.1 ASTM Standards:
and from 0.13 to 4.75 mm [0.005 to 0.1875 in.] in thickness.
E8/E8M Test Methods for Tension Testing of Metallic Ma-
terials 3.1.5 strip—a flat product less than 150 mm [6 in.] in width
E29 Practice for Using Significant Digits in Test Data to
and from 0.13 to 4.75 mm [0.005 to 0.1875 in.] in thickness,
Determine Conformance with Specifications which may be supplied in coil.
F981 Practice for Assessment of Compatibility of Biomate-
3.1.6 wire—material up to 3.15 mm [0.124 in.] in diameter
rials for Surgical Implants with Respect to Effect of
furnished in coils or on spools or reels.
Materials on Muscle and Insertion into Bone
IEEE/ASTM SI 10 American National Standard for Metric 4. Ordering Information
Practice
4.1 Inquiries and orders under this specification shall in-
clude the following information:
1
4.1.1 Quantity (weight or number of pieces);
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
4.1.2 ASTM designation, alloy number, and date of issue;
Subcommittee F04.12 on Metallurgical Materials.
4.1.3 Units to be used for certification (SI or inch-pound);
Current edition approved Feb. 15, 2022. Published February 2022. Originally
4.1.4 Composition designation (see 5.1);
approved in 1978. Last previous edition approved in 2017 as F560 – 17. DOI:
10.1520/F0560-22. 4.1.5 Form (strip, sheet, plate, bar, wire) (see 3.1);
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3
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.
*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
1

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F560−22
4.1.6 Condition (see 5.4); elements, whether residual elements or trace elements, that can
4.1.7 Applicable dimensions, including size, thickness, bepresent.Theproducerispermittedtoanalyzeforunspecified
width, and length (random, exact, multiples), or drawing elementsandispermittedtoreportsuchanalyses.Thepresence
number; of an unspecified element and the reporting of an analysis for
4.1.8 Special tests; that element s
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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: F560 − 17 F560 − 22
Standard Specification for
Unalloyed Tantalum for Surgical Implant Applications (UNS
1
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
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
3
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:
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 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.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
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
1

---------------------- Page: 1 ----------------------
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 inc
...