ASTM F564-10
(Specification)Standard Specification and Test Methods for Metallic Bone Staples
Standard Specification and Test Methods for Metallic Bone Staples
ABSTRACT
This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples. Different test methods shall be performed in order to determine the following mechanical properties of metallic bone staples: bending fatigue, pull-out fixation strength, soft tissue fixation strength, and elastic static bending.
SIGNIFICANCE AND USE
A1.3.1 This test method is used to determine the fatigue resistance of metallic bone staples when subjected to repetitive loading for large numbers of cycles. This information may also be useful for comparing the effect of variations in staple material, geometry, surface condition, or placement under certain circumstances.
A1.3.2 It is essential that uniform fatigue practices be established in order that such basic fatigue data be comparable and reproducible and can be correlated among laboratories.
A1.3.3 The results of fatigue tests are suitable for direct application to design only when the service conditions parallel the test conditions exactly. This test method may not be appropriate for all types of bone staple applications. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application.
SCOPE
1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples.
1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:
1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone StaplesAnnex A1.
1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone StaplesAnnex A2.
1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone StaplesAnnex A3.
1.2.4 Test Method for Elastic Static Bending of Metallic Bone StaplesAnnex A4.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation:F564 −10
StandardSpecification and Test Methods for
1
Metallic Bone Staples
ThisstandardisissuedunderthefixeddesignationF564;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. Scope E122 Practice for Calculating Sample Size to Estimate,With
Specified Precision, the Average for a Characteristic of a
1.1 This specification covers characterization of the design
Lot or Process
and mechanical function of metallic staples used in the internal
E467 Practice for Verification of Constant Amplitude Dy-
fixation of the muscular skeletal system. It is not the intention
namic Forces in an Axial Fatigue Testing System
of this specification to describe or specify specific designs for
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
metallic bone staples.
Alloy Castings and Casting Alloy for Surgical Implants
1.2 This specification includes the following four test meth-
(UNS R30075)
ods for measuring mechanical properties of metallic bone
F86 Practice for Surface Preparation and Marking of Metal-
staples:
lic Surgical Implants
1.2.1 Test Method for ConstantAmplitude Bending Fatigue
F382 SpecificationandTestMethodforMetallicBonePlates
Tests of Metallic Bone Staples—Annex A1.
F565 Practice for Care and Handling of Orthopedic Implants
1.2.2 Test Method for Pull-Out Fixation Strength of Metal-
and Instruments
lic Bone Staples—Annex A2.
F601 Practice for Fluorescent Penetrant Inspection of Me-
1.2.3 Test Method for Soft Tissue Fixation Strength of
tallic Surgical Implants
Metallic Bone Staples—Annex A3.
1.2.4 Test Method for Elastic Static Bending of Metallic F629 Practice for Radiography of Cast Metallic Surgical
Bone Staples—Annex A4. Implants
1.3 The values stated in SI units are to be regarded as
3. Finish
standard. No other units of measurement are included in this
standard.
3.1 Staples conforming to this specification shall be finished
1.4 This standard does not purport to address all of the and identified in accordance with Practice F86, as appropriate.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4. Inspection Practices
priate safety and health practices and determine the applica-
4.1 Staples made in accordance with Specification F75
bility of regulatory limitations prior to use.
should be inspected in accordance with Practice F601 or
2. Referenced Documents
X-rayed in accordance with Practice F629.
2
2.1 ASTM Standards:
5. Care and Handling
E4 Practices for Force Verification of Testing Machines
5.1 Staples should be cared for and handled in accordance
1
This specification is under the jurisdiction of ASTM Committee F04 on
with Practice F565, as appropriate.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.21 on Osteosynthesis.
Current edition approved Sept. 1, 2010. Published September 2010. Originally
6. Keywords
ε1
approved in 1985. Last previous edition approved in 2006 as F564 – 02 (2006) .
DOI: 10.1520/F0564-10. 6.1 bendingtest;bonefixation;fatiguetest;fixationdevices;
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
metallic bone staples; orthopaedic medical devices; pullout
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
test; soft tissue fixation; surgical implants
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F564−10
ANNEXES
(Mandatory Information)
A1. TEST METHOD FOR CONSTANT AMPLITUDE BENDING FATIGUE TESTS OF METALLIC BONE STAPLES
A1.1. Scope theapplicationofbendingfatigueloads.Thelegsofeachstaple
are fitted into fixation holes in each block with minimal
A1.1.1 This test method covers procedures for the perfor-
clearance to restrict bending of the staple within the hole. The
mance of constant amplitude fatigue testing of metallic staples
staple is fixed securely in the block using a moldable filling or
used in internal fixation of the musculoskeletal system. This
grouting agent. The extension design should minimize the
test method may be used when testing in air at ambient
weight to reduce the influence on the staple while maintaining
temperature or in an aqueous or physiological solution.
sufficient stiffness to transfer the load to the staple without
A1.1.2 The values stated in SI units are to be regarded as
undesirable deflection. Holes for pin and clevis fixation are
standard. No other units of measurement are included i
...
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.
´1
Designation:F564–02 (Reapproved 2006) Designation: F564 – 10
Standard Specification and Test Methods for
1
Metallic Bone Staples
ThisstandardisissuedunderthefixeddesignationF564;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
´ NOTE—Units information was editorially corrected in September 2009.
1. Scope
1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal
fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for
metallic bone staples.
1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:
1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples—Annex A1.
1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone Staples—Annex A2.
1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples—Annex A3.
1.2.4 Test Method for Elastic Static Bending of Metallic Bone Staples—Annex A4.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E4 Practices for Force Verification of Testing Machines
E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or
Process
E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F382 Specification and Test Method for Metallic Bone Plates
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F629 Practice for Radiography of Cast Metallic Surgical Implants
3. Finish
3.1 Staples conforming to this specification shall be finished and identified in accordance with Practice F86, as appropriate.
4. Inspection Practices
4.1 Staples made in accordance with Specification F75 should be inspected in accordance with Practice F601 or X-rayed in
accordance with Practice F629.
5. Care and Handling
5.1 Staples should be cared for and handled in accordance with Practice F565, as appropriate.
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
F04.21 on Osteosynthesis.
Current edition approved March 1, 2006. Published April 2006. Originally approved in 1985. Last previous edition approved in 2002 as F564–02. DOI:
10.1520/F0564-02R06E01.
´1
Current edition approved Sept. 1, 2010. Published September 2010. Originally approved in 1985. Last previous edition approved in 2006 as F564 – 02 (2006) . DOI:
10.1520/F0564-10.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F564 – 10
6. Keywords
6.1 bending test; bone fixation; fatigue test; fixation devices; metallic bone staples; orthopaedic medical devices; pullout test;
soft tissue fixation; surgical implants
ANNEXES
(Mandatory Information)
A1. TEST METHOD FOR CONSTANT AMPLITUDE BENDING FATIGUE TESTS OF METALLIC BONE STAPLES
A1.1 Scope
A1.1.1 This test method covers procedures for the performance of constant amplitude fatigue testing of metallic staples used
in internal fixation of the musculoskeletal system. This test method may be used when testing in air at ambient temperature or in
an aqueous or physiological solution.
A1.1.2 The values stated in SI u
...
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