ASTM F560/F560M-13

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

SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip, bar, and wire used in the manufacture of surgical implants.  
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 of the two systems may result in non-conformance with this standard.

General Information

• Status: Historical
• Publication Date: 30-Sep-2013
• 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)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F560/F560M −13
StandardSpecification for
Unalloyed Tantalum for Surgical Implant Applications (UNS
1
R05200, UNS R05400)
This standard is issued under the fixed designation F560/F560M; 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
1.1 This specification covers the chemical, mechanical, and 3.1 Definitions of Terms Specific to This Standard:
metallurgical requirements for unalloyed tantalum plate, sheet, 3.1.1 lot—all material produced from the same ingot or a
strip, bar, and wire used in the manufacture of surgical
single powder blend with the same cross section under the
implants. same conditions at essentially the same time.
1.2 The values stated in either SI units or inch-pound units 3.1.2 plate—a flat product more than 4.75 mm [0.1875 in.]
in thickness.
are to be regarded separately as standard. The values stated in
each system may not be exact equivalents; therefore, each
3.1.3 bar—material 3.15 to 63.5 mm [0.125 to 2.5 in.] in
system shall be used independently of the other. Combining
diameter in round, hexagonal, or octagonal cross section
values of the two systems may result in non-conformance with
supplied in straight lengths.
this standard.
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.
2. Referenced Documents
3.1.5 strip—a flat product less than 150 mm [6 in.] in width
2
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-
may be supplied in coil.
terials
3.1.6 wire—material up to 3.15 mm [0.124 in.] in diameter
E29 Practice for Using Significant Digits in Test Data to
furnished in coils or on spools or reels.
Determine Conformance with Specifications
F981 Practice for Assessment of Compatibility of Biomate-
4. Ordering Information
rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
4.1 Inquiries and orders under this specification shall in-
IEEE/ASTM SI 10 American National Standard for Use of
clude the following information:
theInternationalSystemofUnits(SI):TheModernMetric
4.1.1 Quantity (weight or number of pieces),
System
4.1.2 ASTM designation, alloy number, and date of issue,
3
2.2 ISO Standards:
4.1.3 Units to be used for certification—SI or inch-pound.
ISO 6892 Metallic Materials Tensile Testing at Ambient
4.1.4 Composition designation (see 5.1)
Temperature
4.1.5 Form (strip, sheet, plate, bar, wire) (see 3.1),
ISO 9001 Quality Management Systems—Requirements
4.1.6 Condition (see 5.4),
ISO 13782 Implants for Surgery—Metallic Materials—
4.1.7 Applicable dimensions, including size, thickness,
Unalloyed Tantalum for Surgical Implant Applications
width, and length (random, exact, multiples), or drawing
number,
4.1.8 Special tests,
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.9 Special requirements, and
Medical and Surgical Materials and Devices and is the direct responsibility of
4.1.10 Mechanical properties (if applicable for special con-
Subcommittee F04.12 on Metallurgical Materials.
ditions) (see 7.1).
Current edition approved Oct. 1, 2013. Published November 2013. Originally
approved in 1978. Last previous edition approved in 2008 as F560 – 08. DOI:
10.1520/F0560_F0560M-13.
5. Materials and Manufacture
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
5.1 Material covered by this specification shall be made
Standards volume information, refer to the standard’s Document Summary page on
from vacuum-arc melted or electron-beam melted ingots
the ASTM website.
3
(R05200) or powder-metallurgy consolidated (R05400) unal-
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. loyed tantalum.
*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/F560M−13
TABLE 2 Additional Chemical Requirements for Finished Product
5.2 The various tantalum mill products covered by this
(When Specified by the Purchaser)
specification are formed with the conventional extrusion,
Element Compositions, Maximum % mass/mass
forming, swaging, rolling, and drawing equipment normally
A B
R05200 R05400
available in metalworking plants.
Carbon 0.020 0.020
Oxygen 0.025 0.035
5.3 Finish—The mill product may be furnished
...

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 − 08 F560/F560M − 13
Standard Specification for
Unalloyed Tantalum for Surgical Implant Applications (UNS
1
R05200, UNS R05400)
This standard is issued under the fixed designation F560;F560/F560M; 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.
This standard has been approved for use by agencies of the Department of Defense.
1. Scope*
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip,
rod,bar, and wire used in the manufacture of surgical implants.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values given in
parentheses are mathematical conversions to SI units that are provided for information only and are not considered stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values of the
two systems may result in non-conformance with this standard.
2. Referenced Documents
2
2.1 ASTM Standards:
E8E8/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 Bone
IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
3
2.2 American Society for Quality Control Standard:
ASQ C1 Specifications of General Requirements for a Quality Program
3
2.2 ISO Standard:Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems—Requirements
ISO 13782 Implants for Surgery—Metallic Materials—Unalloyed Tantalum for Surgical Implant Applications
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 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.
3.1.2 plate—a flat product more than 0.1875 in. (4.7 mm)4.75 mm [0.1875 in.] in thickness.
3.1.3 rod—bar—material 0.125 to 2.5 in. (3.18 to 63.50 mm)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 6 in. (152.4 mm)150 mm [6 in.] or more in width and from 0.005 to 0.1875 in. (0.13 to 4.76 mm)0.13
to 4.75 mm [0.005 to 0.1875 in.] in thickness.
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 May 1, 2008Oct. 1, 2013. Published May 2008November 2013. Originally approved in 1978. Last previous edition approved in 20072008 as
F560 – 07.F560 – 08. DOI: 10.1520/F0560-08.10.1520/F0560_F0560M-13.
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 Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.10036, 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/F560M − 13
3.1.5 strip—a flat product, may be supplied in coil, less than 6 in. (152.4 mm)product less than 150 mm [6 in.] in width and
from 0.005 to 0.1875 in. (0.13 to 4.76 mm) in thickness.0.13 to 4.75 mm [0.005 to 0.1875 in.] in thickness, may be supplied in
coil.
3.1.6 wire—material to 0.124 in. (0.254 to 3.15 mm) 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 designation, alloy number, and date of issue,
4.1.3 Units to be used for c
...