ASTM F560-98
(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)
SCOPE
1.1 This specification covers the requirements for unalloyed tantalum sheet, rod, and wire used for the manufacture of surgical implants.
1.2 The material has been subjected to animal implant studies and has been shown to produce a well-characterized level of biological response that is equal to or less than that produced by the reference material when tested by the procedures of Practice F981 or the equivalent. This material has been used clinically .
1.3 The values stated in inch-pound units are to be regarded as the standard. The metric equivalents of inch-pound units may be approximate.
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NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 560 – 98
Standard Specification for
Unalloyed Tantalum for Surgical Implant Applications (UNS
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 3.2 In the case where a conflict exists between this specifi-
cation and those listed in 2.1 and 2.2, this specification shall
1.1 This specification covers the requirements for unalloyed
take precedence.
tantalum sheet, rod, and wire used for the manufacture of
surgical implants.
1.2 The values stated in inch-pound units are to be regarded
TABLE 1 Chemical Requirements (Ingot)
as the standard. The metric equivalents of inch-pound units
A
Compositions, Maximum Weight Percent Allowed
may be approximate.
Element
B C
R05200 R05400
2. Referenced Documents
Carbon 0.010 0.010
Oxygen 0.0150 0.030
2.1 ASTM Standards:
Nitrogen 0.010 0.010
B 364 Specification for Tantalum and Tantalum Alloy In-
Hydrogen 0.0015 0.0015
Niobium 0.100 0.100
gots
Iron 0.010 0.010
B 365 Specification for Tantalum and Tantalum Alloy Rod
Titanium 0.010 0.010
and Wire
Tungsten 0.05 0.05
Molybdenum 0.020 0.020
B 708 Specification for Tantalum and Tantalum Alloy Plate,
Silicon 0.0050 0.0050
Sheet, and Strip
Nickel 0.010 0.010
E 8 Test Methods of Tension Testing of Metallic Materials
Tantalum balance balance
A
E 29 Practice for Using Significant Digits in Test Data to
For purposes of determining conformance with this specification, all compo-
sitional limits are absolute limits, as defined in Practice E 29.
Determine Conformance with Specifications
B
Electron beam or vacuum-arc cast tantalum.
F 981 Practice for Assessment of Compatibility of Bioma-
C
Sintered tantalum.
terials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
2.2 American Society for Quality Control Standard:
4. Ordering Information
Cl Specifications of General Requirements for a Quality
4.1 Inquiries and orders under this specification shall in-
Program
clude the following information:
4.1.1 Quantity (weight and number of pieces),
3. General Requirements for Delivery
4.1.2 ASTM designation,
3.1 In addition to the requirements of this specification, all
4.1.3 Composition designation,
requirements of the current editions of Specifications B 364,
4.1.4 Form (sheet, rod, wire)
B 365, and B 708 shall apply.
4.1.5 Condition (see 5.1)
4.1.6 Applicable dimensions, including size, thickness,
width, and length (random, exact, multiples), or print number,
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
and Surgical Materials and Devices, and is the direct responsibility of Subcommittee
4.1.7 Special tests, and
F04.12 on Metallurgical Materials.
4.1.8 Special requirements.
Current edition approved January 10, 1998. Published June 1998. Originally
published as F 560 – 78. Last previous edition F 560 – 92.
5. Manufacture
Annual Book of ASTM Standards, Vol 02.04.
Annual Book of ASTM Standards, Vol 03.01.
5.1 Condition:
Annual Book of ASTM Standards, Vol 14.02.
5.1.1 Flat mill products material shall be supplied in the
Annual Book of ASTM Standards, Vol 13.01.
cold-worked, cold-worked and stress-relieved or annealed
Available from American Society for Quality Control, 161 West Wisconsin
Ave., Milwaukee, WI 53203. condition.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 560
TABLE 2 Mechanical Properties, Flat Mill Products
Ulimate Tensile Yeild Strength, Elongation
Condition Thickness, in. (mm) Strength, min, psi (0.2% offset) min, in 1 inch (25.4 mm),
(MPa) psi (MPa) min,%
Cold worked all 75 000 (517) 50 000 (345) 2
Stress relieved 0.0051 to 0.010 55 000 (379) 35 000 (241) 5
(0.13 to 0.26)
over 0.010 to 0.020 55 000 (379) 35 000 (241) 10
(0.26 to 0.51)
over 0.020( 0.51) 55 000 (379) 35 000 (241) 10
Annealed 0.0051 to 0.010 30 000 (207) 20 000 (138) 20
(0.13 to 0.26)
over 0.010 to 0.020 30 000 (207) 20 000 (138) 25
(0.26 to 0.51)
over 0.020 (0.51) 30 000 (207) 20 000 (138) 30
TABLE 3 Mechanical Properties, Rod and Wire Products
Ultimate Tensile Yield
Elongation,
Condition Diameter, in. (mm) Strength, min, psi Strength, (0.2%
A
min, %
(MPa) offset)min, psi (MPa)
Cold Worked all 70 000 (
...
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