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 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.

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)

Citing ASTM Standards

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