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ASTM F560-13e1

(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, 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
Current Stage
Ref Project

Relations

Replaces
ASTM F560-08 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
Effective Date
01-Oct-2013
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
01-Oct-2013

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ASTM F560-13e1 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)ASTM F560-13e1 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
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ASTM F560-13e1 - 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
´1
Designation:F560 −13
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.
1
ε NOTE—The designation was corrected editorially in December 2013.
1. Scope* ISO 13782 Implants for Surgery—Metallic Materials—
Unalloyed Tantalum for Surgical Implant Applications
1.1 This specification covers the chemical, mechanical, and
metallurgical requirements for unalloyed tantalum plate, sheet,
3. Terminology
strip, bar, and wire used in the manufacture of surgical
implants. 3.1 Definitions of Terms Specific to This Standard:
3.1.1 lot—all material produced from the same ingot or a
1.2 The values stated in either SI units or inch-pound units
single powder blend with the same cross section under the
are to be regarded separately as standard. The values stated in
same conditions at essentially the same time.
each system may not be exact equivalents; therefore, each
system shall be used independently of the other. Combining
3.1.2 plate—a flat product more than 4.75 mm [0.1875 in.]
values of the two systems may result in non-conformance with
in thickness.
this standard.
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
2. Referenced Documents
supplied in straight lengths.
2
2.1 ASTM Standards:
3.1.4 sheet—a flat product 150 mm [6 in.] or more in width
E8/E8M Test Methods for Tension Testing of Metallic Ma-
and from 0.13 to 4.75 mm [0.005 to 0.1875 in.] in thickness.
terials
E29 Practice for Using Significant Digits in Test Data to 3.1.5 strip—a flat product less than 150 mm [6 in.] in width
Determine Conformance with Specifications and from 0.13 to 4.75 mm [0.005 to 0.1875 in.] in thickness,
F981 Practice for Assessment of Compatibility of Biomate- may be supplied in coil.
rials for Surgical Implants with Respect to Effect of
3.1.6 wire—material up to 3.15 mm [0.124 in.] in diameter
Materials on Muscle and Bone
furnished in coils or on spools or reels.
IEEE/ASTM SI 10 American National Standard for Use of
theInternationalSystemofUnits(SI):TheModernMetric
4. Ordering Information
System
3 4.1 Inquiries and orders under this specification shall in-
2.2 ISO Standards:
clude the following information:
ISO 6892 Metallic Materials Tensile Testing at Ambient
4.1.1 Quantity (weight or number of pieces),
Temperature
4.1.2 ASTM designation, alloy number, and date of issue,
ISO 9001 Quality Management Systems—Requirements
4.1.3 Units to be used for certification—SI or inch-pound.
4.1.4 Composition designation (see 5.1)
1
This specification is under the jurisdiction of ASTM Committee F04 on 4.1.5 Form (strip, sheet, plate, bar, wire) (see 3.1),
Medical and Surgical Materials and Devices and is the direct responsibility of
4.1.6 Condition (see 5.4),
Subcommittee F04.12 on Metallurgical Materials.
4.1.7 Applicable dimensions, including size, thickness,
Current edition approved Oct. 1, 2013. Published November 2013. Originally
approved in 1978. Last previous edition approved in 2008 as F560 – 08. DOI:
width, and length (random, exact, multiples), or drawing
10.1520/F0560-13E01.
number,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4.1.8 Special tests,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
4.1.9 Special requirements, and
the ASTM website.
3
4.1.10 Mechanical properties (if applicable for special con-
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. ditions) (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 ----------------------
´1
F560−13
TABLE 2 Additional Chemical Requirements for Finished Product
5. Materials and Manufacture
(When Specified by the Purchaser)
5.1 Material covered by this specification shall be made
Element Compositions, Maximum % mass/mass
from vacuum-arc melted or electron-beam melted ingots A B
R05200 R05400
Carbon 0.020 0.020
(R05200) or powder-metallurgy consolidated (R05400) unal-
Oxygen 0.025 0.035
loyed tantalum.
Nitrogen 0.010 0.010
Hydrogen 0.0015 0.0015
5.2 The various tantalum mill products covered by this
A
specification are formed with the conventional extrusion, Electron-beam or vacuum-arc cast tantalum.
B
Sintered tanta
...

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4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
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1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
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1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.

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    English language
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