Full Description

1.1This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the musculoskeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples.

1.2This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:

1.2.1Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples-Annex A1.

1.2.2Test Method for Pull-Out Fixation Strength of Metallic Bone Staples-Annex A2.

1.2.3Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples-Annex A3.

1.2.4Test Method for Elastic Static Bending of Metallic Bone Staples-Annex A4.

1.3The values stated in SI units are to be regarded as standard. Any other units of measurement included in this standard are shown for reference only.

1.4Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods.

1.5This 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, health and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.