ASTM F560-08
(Specification)Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip, rod, and wire for the manufacture of surgical implants. Material covered by this specification shall be made from vacuum-arc melted or electron-beam melted ingots (UNS R05200) or powder-metallurgy consolidated (UNS R05400) unalloyed tantalum. Tantalum mill products shall be formed with the conventional extrusion, forming, swaging, rolling, and drawing equipment, and may be furnished as descaled or pickled, abrasive blasted, chemically milled, ground, machined, peeled, or polished. Flat mill products shall be supplied in the cold-worked, cold-worked and stress-relieved, or annealed condition while rod and wire products shall be supplied in the annealed or cold worked condition. The material shall conform to the chemical composition requirements prescribed for: carbon, oxygen, nitrogen, hydrogen, niobium, iron, titanium, tungsten, molybdenum, silicon, nickel, and tantalum, as determined by ingot chemical analysis. The mechanical property requirements specified includes: ultimate tensile strength, yield strength, and elongation. Tension test shall be performed at least once for each lot of the material.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip, rod, and wire used in the manufacture of surgical implants.
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
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Designation:F560 −08
StandardSpecification 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.
This standard has been approved for use by agencies of the Department of Defense.
1. Scope* 3.1.1 lot—all material produced from the same ingot or a
single powder blend with the same cross section under the
1.1 This specification covers the chemical, mechanical, and
same conditions at essentially the same time.
metallurgical requirements for unalloyed tantalum plate, sheet,
3.1.2 plate—a flat product more than 0.1875 in. (4.7 mm) in
strip, rod, and wire used in the manufacture of surgical
thickness.
implants.
3.1.3 rod—material 0.125 to 2.5 in. (3.18 to 63.50 mm) in
1.2 The values stated in inch-pound units are to be regarded
diameter in round, hexagonal, or octagonal cross section
as standard. The values given in parentheses are mathematical
supplied in straight lengths.
conversions to SI units that are provided for information only
and are not considered standard.
3.1.4 sheet—a flat product 6 in. (152.4 mm) or more in
width and from 0.005 to 0.1875 in. (0.13 to 4.76 mm) in
2. Referenced Documents
thickness.
2
2.1 ASTM Standards:
3.1.5 strip—a flat product, may be supplied in coil, less than
E8 Test Methods for Tension Testing of Metallic Materials
6 in. (152.4 mm) in width and from 0.005 to 0.1875 in. (0.13
E29 Practice for Using Significant Digits in Test Data to
to 4.76 mm) in thickness.
Determine Conformance with Specifications
3.1.6 wire—material to 0.124 in. (0.254 to 3.15 mm) in
F981 Practice for Assessment of Compatibility of Biomate-
diameter furnished in coils or on spools or reels.
rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone 4. Ordering Information
3
2.2 American Society for Quality Control Standard:
4.1 Inquiries and orders under this specification shall in-
ASQ C1 Specifications of General Requirements for a
clude the following information:
Quality Program
4.1.1 Quantity (weight or number of pieces),
4
2.3 ISO Standard: 4.1.2 ASTM designation and date of issue,
ISO 6892 Metallic Materials Tensile Testing at Ambient 4.1.3 Composition designation (see 5.1)
Temperature 4.1.4 Form (strip, sheet, plate, rod, wire) (see 3.1),
4.1.5 Condition (see 5.4),
3. Terminology
4.1.6 Applicable dimensions, including size, thickness,
width, and length (random, exact, multiples), or drawing
3.1 Definitions of Terms Specific to This Standard:
number,
4.1.7 Special tests,
1
4.1.8 Special requirements, and
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
4.1.9 Mechanical properties (if applicable for special con-
Subcommittee F04.12 on Metallurgical Materials.
ditions) (see 7.1).
Current edition approved May 1, 2008. Published May 2008. Originally
approved in 1978. Last previous edition approved in 2007 as F560 – 07. DOI:
5. Materials and Manufacture
10.1520/F0560-08.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
5.1 Material covered by this specification shall be made
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
from vacuum-arc melted or electron-beam melted ingots
Standards volume information, refer to the standard’s Document Summary page on
(R05200) or powder-metallurgy consolidated (R05400) unal-
the ASTM website.
3
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., loyed tantalum.
Milwaukee, WI 53203.
4
5.2 The various tantalum mill products covered by this
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036. specification are formed with the conventional extrusion,
*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 ----------------------
F560−08
TABLE 2 Additional Chemical Requirements for Finished Product
forming, swaging, rolling, and drawing equipment normally
(When Specified by Purchaser)
available in metalworking plants.
Element Compositions, Maximum % mass/mass
5.3 Finish—The mill product may be furnished as descaled A B
R05200 R05400
Carbon 0.020 0.020
or pickled, abrasive blasted, chemically milled, ground,
Oxygen 0.025 0.035
machined, peeled, polished, or as specified by the purchaser.
Nitrogen 0.010 0.010
Hydrogen 0.0015 0.0015
5.4 Condition:
A
5.4.1 Flat mill prod
...
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:F560–07 Designation: F 560 – 08
Standard Specification for
Unalloyed Tantalum for Surgical Implant Applications (UNS
1
R05200, UNS R05400)
This standard is issued under the fixed designation F 560; 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 (e) 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 Thisspecificationcoversthechemical,mechanical,andmetallurgicalrequirementsforunalloyedtantalumplate,sheet,strip,
rod, and wire used in the manufacture of surgical implants.
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
2. Referenced Documents
2
2.1 ASTM Standards:
E 8 Test Methods for Tension Testing of Metallic Materials
E 29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
3
2.2 American Society for Quality Control Standard:
ASQ C1 Specifications of General Requirements for a Quality Program
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 Oct. 15, 2007. Published October 2007. Originally approved in 1978. Last previous edition approved in 2005 as F560–05.
Current edition approved May 1, 2008. Published May 2008. Originally approved in 1978. Last previous edition approved in 2007 as F 560 – 07.
2
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.
3
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203.
*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 ----------------------
F560–08
4
2.3 ISO Standard:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
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) in thickness.
3.1.3 rod—material 0.125 to 2.5 in. (3.18 to 63.50 mm) 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) or more in width and from 0.005 to 0.1875 in. (0.13 to 4.76 mm) in thickness.
3.1.5 strip—a flat product, may be supplied in coil, less than 6 in. (152.4 mm) in width and from 0.005 to 0.1875 in. (0.13 to
4.76 mm) in thickness.
3.1.6 wire—material 0.010 to 0.124 in. (0.254 to 3.15 mm) in diameter furnished in coils or on spools or reels. Material less
than 0.010 in. in diameter is not covered by this specification. —material to 0.124 in. (0.254 to 3.15 mm) 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 and date of issue,
4.1.3 Composition designation (see 5.1)
4.1.4 Form (strip, sheet, plate, rod, wire) (see 3.1),
4.1.5 Condition (see 5.4),
4.1.6 Applicable dimensions, including size, thickness, width, and length (random, exact, multiples), or drawing number,
4.1.7 Special tests,
4.1.8 Special requirements, and
4.1.9 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 e
...
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