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ASTM F560-04

(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 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 the standard. The SI equivalents in parentheses are for information only.

General Information

Status
Historical
Publication Date
31-Dec-2003
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
Current Stage
Ref Project

Relations

Replaces
ASTM F560-98 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
Effective Date
01-Jan-2004
Replaced By
ASTM F560-05 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications(UNS R05200, UNS R05400)
Effective Date
01-May-2005
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
01-Jan-2004

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ASTM F560-04 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)ASTM F560-04 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
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ASTM F560-04 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F 560 – 04
Standard Specification for
Unalloyed Tantalum for Surgical Implant Applications
1
(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. General Requirements for Delivery
1.1 This specification covers the chemical, mechanical, and 3.1 In addition to the requirements of this specification, all
metallurgical requirements for unalloyed tantalum plate, sheet, requirements of the current editions of Specifications B 364,
strip, rod, and wire used in the manufacture of surgical B 365, and B 708 shall apply.
implants. 3.2 In the case where a conflict exists between this specifi-
1.2 The values stated in inch-pound units are to be regarded cation and those listed in 2.1, 2.2, and 3.1, this specification
as the standard. The SI equivalents in parentheses are for shall take precedence.
information only.
TABLE 1 Chemical Requirements (Ingot)
2. Referenced Documents
A
2
Compositions, max % mass/mass
2.1 ASTM Standards:
Element
B C
R05200 R05400
B 364 Specification for Tantalum and Tantalum Alloy In-
gots
Carbon 0.010 0.010
Oxygen 0.015 0.03
B 365 Specification for Tantalum and Tantalum Alloy Rod
Nitrogen 0.010 0.010
and Wire
Hydrogen 0.0015 0.0015
B 708 Specification forTantalum andTantalumAlloy Plate, Niobium 0.10 0.10
Iron 0.010 0.010
Sheet, and Strip
Titanium 0.010 0.010
E 8 Test Methods for Tension Testing of Metallic Materials
Tungsten 0.050 0.050
E 29 Practice for Using Significant Digits in Test Data to
Molybdenum 0.020 0.020
Silicon 0.005 0.005
Determine Conformance with Specifications
Nickel 0.010 0.010
F 981 Practice for Assessment of Compatibility of Bioma- D D
Tantalum balance balance
terials for Surgical Implants with Respect to Effect of
A
For purposes of determining conformance with this specification, all compo-
Materials on Muscle and Bone
sitional limits are absolute limits, as defined in Practice E 29.
B
3
Electron beam or vacuum-arc cast tantalum.
2.2 American Society for Quality Control Standard:
C
Sintered tantalum.
ASQ C1 Specifications of General Requirements for a
D
The percentage of tantalum is determined by difference and need not be
Quality Program
determined or certified.
4
2.3 ISO Standard:
ISO 6892 Metallic Materials Tensile Testing at Ambient
4. Ordering Information
Temperature
4.1 Inquiries and orders under this specification shall in-
clude the following information:
4.1.1 Quantity (weight or number of pieces),
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.2 ASTM designation,
Medical and Surgical Materials and Devices and is the direct responsibility of
4.1.3 Composition designation,
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Jan. 1, 2004. Published February 2004. Originally
4.1.4 Form (strip, sheet, plate, rod, wire),
approved in 1978. Last previous edition approved in 1998 as F 560 – 98.
4.1.5 Condition (see 5.1),
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4.1.6 Applicable dimensions, including size, thickness,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
width, and length (random, exact, multiples), or drawing
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
number,
3
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
4.1.7 Special tests,
Milwaukee, WI 53203.
4
4.1.8 Special requirements, and
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036. 4.1.9 Mechanical properties (see 7.1).
*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 ----------------------
F560–04
TABLE 2 Mechanical Properties, Flat Mill Products
A
Ultimate Tensile Yield 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
A
Elongation of materi
...

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1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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.

  • Technical specification
    22 pages
    English language
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  • Technical specification
    22 pages
    English language
    sale 15% off