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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for
its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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.
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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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
Keywords
bending test; bone fixation; fatigue test; fixation devices; metallic bone staples; orthopaedic medical devices; pullout test; soft tissue fixation; surgical implants; Bone implant
materials/applications--specifications; Constant amplitude bending fatigue test; Orthopaedic medical devices--specifications; Orthopaedic medical devices (bone)--specifications; Pull-out
fixation strength; Soft tissue implant materials; Staples;
ICS Code
ICS Number Code 11.040.30 (Surgical instruments and materials)
DOI: 10.1520/F0564-10
ASTM International is a member of CrossRef.
ASTM F564