Designation

This standard is issued under the fixed designation F1264; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (ε) indicates an editorial change since the last revision or reapproval.

1. Scope

1.1

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.

1.2

This specification describes IMFDs for surgical fixation of the skeletal system. It provides basic IMFD geometrical definitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methods; and characteristics determined to be important to in vivo performance of the device.

1.3

Multiple 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.

1.4

This specification includes four standard test methods:

1.4.1

Static Four-Point Bend Test Method—Annex A1.

1.4.2

Static Torsion Test Method—Annex A2.

1.4.3

Bending Fatigue Test Method—Annex A3.

1.4.4

Test Method for Bending Fatigue of IMFD Locking Screws—Annex A4.

1.5

A rationale is given in Appendix X1.

1.6

The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.7

This standard does not purport to address all of thesafety 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.

1.8

This 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.

2. Referenced Documents

2.1

2.2

2.3

3. Terminology

3.1

3.2

4. Classification

4.1

4.2

5. Material

5.1

5.2

6. Performance Considerations and Test Methods

6.1

6.2

6.3

6.4

6.5

6.6

6.7

7. Marking, Packaging, Labeling, and Handling

7.1

7.2

7.3

7.4

7.5

7.6

7.7

8. Means for Insertion and Extraction

8.1

9. Keywords

9.1

ASTM F1264 - 24

Standard Specification and Test Methods for Intramedullary Fixation Devices

Current

Published:

15 Aug 2024