ASTM F564-17
(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 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 musculoskeletal 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. Any other units of measurement included in this standard are shown for reference only.
1.4 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 be only a subset of the herein described test methods.
1.5 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.
1.6 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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Standards Content (Sample)
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.
Designation:F564 −17
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. Scope mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This specification covers characterization of the design
and mechanical function of metallic staples used in the internal
2. Referenced Documents
fixation of the musculoskeletal system. It is not the intention of
2
2.1 ASTM Standards:
this specification to describe or specify specific designs for
E4 Practices for Force Verification of Testing Machines
metallic bone staples.
E122 Practice for Calculating Sample Size to Estimate,With
1.2 This specification includes the following four test meth-
Specified Precision, the Average for a Characteristic of a
ods for measuring mechanical properties of metallic bone
Lot or Process
staples:
E467 Practice for Verification of Constant Amplitude Dy-
1.2.1 Test Method for ConstantAmplitude Bending Fatigue
namic Forces in an Axial Fatigue Testing System
Tests of Metallic Bone Staples—Annex A1.
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
1.2.2 Test Method for Pull-Out Fixation Strength of Metal-
Alloy Castings and Casting Alloy for Surgical Implants
lic Bone Staples—Annex A2.
(UNS R30075)
1.2.3 Test Method for Soft Tissue Fixation Strength of
F86 Practice for Surface Preparation and Marking of Metal-
Metallic Bone Staples—Annex A3.
lic Surgical Implants
1.2.4 Test Method for Elastic Static Bending of Metallic
F382 SpecificationandTestMethodforMetallicBonePlates
Bone Staples—Annex A4.
F565 Practice for Care and Handling of Orthopedic Implants
and Instruments
1.3 The values stated in SI units are to be regarded as
standard. Any other units of measurement included in this F601 Practice for Fluorescent Penetrant Inspection of Me-
tallic Surgical Implants
standard are shown for reference only.
F629 Practice for Radiography of Cast Metallic Surgical
1.4 Multiple test methods are included in this standard.
Implants
However, the user is not necessarily obligated to test using all
F2503 Practice for Marking Medical Devices and Other
of the described methods. Instead, the user should only select,
Items for Safety in the Magnetic Resonance Environment
with justification, test methods that are appropriate for a
particular device design. This may be only a subset of the
3. Finish
herein described test methods.
3.1 Staples conforming to this specification shall be finished
1.5 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, health and environmental practices and deter-
4.1 Staples made in accordance with Specification F75
mine the applicability of regulatory limitations prior to use.
should be inspected in accordance with Practice F601 or
1.6 This international standard was developed in accor-
X-rayed in accordance with Practice F629.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
5. Care and Handling
Development of International Standards, Guides and Recom-
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
2
Subcommittee F04.21 on Osteosynthesis. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 1, 2017. Published October 2017. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1985. Last previous edition approved in 2015 as F564 – 10 (2015). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F0564-17. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F564−17
5.2 Consider Practice F2503 to identify potential hazards Materials should be chosen based on the design requirements
produced by interactions between the device and the MR of the particular device. ASTM subcommittee F04.12 main-
e
...
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.
Designation: F564 − 10 (Reapproved 2015) F564 − 17
Standard Specification and Test Methods for
1
Metallic Bone Staples
This standard is issued under the fixed designation F564; 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 (´) indicates an editorial change since the last revision or reapproval.
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 musculoskeletal 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. NoAny other units of measurement are included in this
standard.standard are shown for reference only.
1.4 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 be only a subset of the herein described test methods.
1.5 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 safety, health and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.6 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.
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
F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
3. Finish
3.1 Staples conforming to this specification shall be finished and identified in accordance with Practice F86, 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, 2015Sept. 1, 2017. Published April 2015October 2017. Originally approved in 1985. Last previous edition approved in 20102015 as
F564 – 10.F564 – 10 (2015). DOI: 10.1520/F0564-10R15.10.1520/F0564-17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 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 the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F564 − 17
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 accordanc
...
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