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Normas ASTM – AENOR
ASTM F564-02(2006)e1

ASTM F564-02(2006)e1

Standard Specification and Test Methods for Metallic Bone Staples

Fecha:
2010-12-31 /Historical
Superseeded by:
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:

A1.3.1 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 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.

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.

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
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