ASTM F1264 – Standard Specification and Test Methods for Intramedullary Fixation Devices
This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs), specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties, and identify needs for further development of test methods and performance criteria. The ultimate goal is to develop a standard which defines performance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of these devices, as insufficient knowledge to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living is available. It is not the intention of this specification to describe or specify specific designs for IMFDs.
This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:
- Annex A1 – Static Four-Point Bend Test Method
- Annex A2 – Static Torsion Test Method
- Annex A3 – Bending Fatigue Test Method
- Annex A4 – Test Method for Bending Fatigue of IMFD Locking Screws
Test results are shown below for each test method Annex.