ASTM F564-02

Standard Specification and Test Methods for Metallic Bone Staples

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 Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values given in parentheses are given for information only.
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.

General Information

• Status: Historical
• Publication Date: 09-Apr-2002
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.21 - Osteosynthesis

Relations

• Replaces: ASTM F564-00 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 10-Apr-2002
• Replaced By: ASTM F564-02(2006) - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 01-Mar-2006

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 564 – 02
Standard Specification and Test Methods for
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Metallic Bone Staples
This standard is issued under the fixed designation F 564; 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.
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1. Scope Characteristic of a Lot or Process
E 467 Practice for Verification of Constant Amplitude Dy-
1.1 This specification covers characterization of the design
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namic Forces in an Axial Load Fatigue Testing Machine
and mechanical function of metallic staples used in the internal
F 75 Specification for Cast Cobalt-28Chromium-
fixation of the muscular skeletal system. It is not the intention
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6MolybdenumAlloyforSurgicalImplants(UNSR30075)
of this specification to describe or specify specific designs for
F 86 Practice for Surface Preparation and Marking of Me-
metallic bone staples.
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tallic Surgical Implants
1.2 This specification includes the following four test meth-
F 382 TestMethodforStaticBendingPropertiesofMetallic
ods for measuring mechanical properties of metallic bone
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Bone Plates
staples:
F 565 Practice for Care and Handling of Orthopedic Im-
1.2.1 Test Method for ConstantAmplitude Bending Fatigue
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plants and Instruments
Tests of Metallic Bone Staples—Annex A1.
F 601 Practice for Fluorescent Penetrant Inspection of Me-
1.2.2 Test Method for Pull-Out Fixation Strength of Metal-
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tallic Surgical Implants
lic Bone Staples—Annex A2.
F 629 Practice for Radiography of Cast Metallic Surgical
1.2.3 Test Method for Soft Tissue Fixation Strength of
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Implants
Metallic Bone Staples—Annex A3.
1.2.4 Test Method for Elastic Static Bending of Metallic
3. Finish
Bone Staples—Annex A4.
3.1 Staples conforming to this specification shall be finished
1.3 Unless otherwise indicated, the values stated in SI units
and identified in accordance with Practice F 86, as appropriate.
are to be regarded as standard. The values given in parentheses
are given for information only.
4. Inspection Practices
1.4 This standard does not purport to address all of the
4.1 Staples made in accordance with Specification F 75
safety concerns, if any, associated with its use. It is the
should be inspected in accordance with Practice F 601 or
responsibility of the user of this standard to establish appro-
X-rayed in accordance with Practice F 629.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
5. Care and Handling
5.1 Staples should be cared for and handled in accordance
2. Referenced Documents
with Practice F 565, as appropriate.
2.1 ASTM Standards:
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E 4 Practices for Force Verification of Testing Machines
6. Keywords
E 122 Practice for Calculating Sample Size to Estimate,
6.1 bendingtest;bonefixation;fatiguetest;fixationdevices;
With a Specified Tolerable Error, the Average for a
metallic bone staples; orthopaedic medical devices; pullout
test; soft tissue fixation; surgical implants
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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 Apr. 10, 2002. Published June 2002. Originally
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published as F 564 – 85. Last previous edition F 564 – 00. Annual Book of ASTM Standards, Vol 14.02.
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Annual Book of ASTM Standards, Vol 03.01. Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F 564
ANNEXES
(Mandatory Information)
A1. TEST METHOD FOR CONSTANT AMPLITUDE BENDING FATIGUE TESTS OF METALLIC BONE STAPLES
A1.1 Scope clearance to restrict bending of the staple within the hole. The
staple is fixed securely in the block using a moldable filling or
A1.1.1 This test method covers procedures for the perfor-
grouting agent. The extension design should minimize the
mance of constant amplitude fatigue testing of metallic staples
weight to reduce the influence on the staple while maintaining
used in internal fixation of the musculoskeletal system. This
sufficient stiffness to transfer the load to the staple without
test method may be used when testing in air at ambient
undesirable deflection. Holes for pin and clevis fixation are
temperature or in an aqueous or physiological solution.
optional (see Figs. A1.1-A1.3).
A1.1.2 ThevaluesstatedinSIunitsaretoberegardedasthe
standard.
NOTE A1.1—Variations in fixation hole configuration may be required
A1.1.3 This standard does not purport to address all of the for staple legs with noncircular cross sections. Also, it is necessary to
provide a
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