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.

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 units are to be regarded as standard. No other units of measurement are included in this standard.

A1.1.3 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.

A2.1.1 This test method covers testing of the hard tissue pull-out fixation strength of metallic staples used in the internal fixation of the musculoskeletal system. This test method may be used with physiologic bone or a synthetic substitute. It may also be used when testing in an aqueous or physiological solution.

A2.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

A2.1.3 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.

A3.1.1 This test method covers testing the soft tissue fixation strength of metallic staples used in internal fixation of the musculoskeletal system. This test method may be used with physiologic soft tissue and bone or synthetic substitutes for either, or both. This test method may also be used when testing in an aqueous or physiological solution.

A3.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

A3.1.3 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.

A4.1.1 This test method covers a procedure for determining the rigidity of bone staples.

A4.1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

A4.1.3 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/F0564-02R06E01

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