ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices

This standard is designed to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs), specify labeling and material requirements, provide test methods for the characterization of IMFD mechanical properties, and identify needs for the further development of test methods and performance criteria.

The ultimate goal is to develop a standard that defines performance criteria and methods for measuring the performance-relevant mechanical properties of IMFDs and their anchoring to bone. It is not the intent of this specification to describe the performance levels or case-specific clinical performance of these devices because insufficient information is available to predict the results of using any of these devices in individual patients for certain activities of daily living.

This standard includes multiple test methods. However, the user does not have to test using all of the methods described. Instead, the user should only select test methods that are justified and appropriate for a particular device design. This may be just a subset of the test methods described here.

This specification includes four standard test methods:

• Static Four-Point Bending Test Method;
• Static Torsion Test Method;
• Flexural Fatigue Test Method;
• Test Method for Bending Fatigue of IMFD Locking Screws.

Values ​​stated in SI units should be accepted as standard. No other units of measurement are included in this standard.

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