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.

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 Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values given in parentheses are given for information only.

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.