ASTM F1264-16e1
Standard specifications and test methods for intramedullary fixation devices

Standard No.

ASTM F1264-16e1

Release Date

2016

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F1264-16e1

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 performancerelated 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 and 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.

ASTM F1264-16e1 Referenced Document

• ASTM A214/A214M Standard Specification for Electric-Resistance-Welded Carbon Steel Heat-Exchanger and Condenser Tubes
• ASTM A450/A450M Standard Specification for General Requirements for Carbon, Ferritic Alloy, and Austenitic Alloy Steel Tubes
• ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-20 Update
• ASTM E4 Standard Practices for Force Verification of Testing Machines
• ASTM E691 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• ASTM F1611 Standard Specification for Intramedullary Reamers
• ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• ASTM F2809 Standard Terminology Relating to Medical and Surgical Materials and Devices
• ASTM F339 Specification for Cloverleaf Intramedullary Pins
• ASTM F565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• SAE AMS5050 STEEL TUBING (SEAMLESS) Low Carbon (Annealed)
• SAE J524 Seamless Low-Carbon Steel Tubing Annealed for Bending and Flaring

ASTM F1264-16e1 history

• 2016 ASTM F1264-16e1 Standard specifications and test methods for intramedullary fixation devices
• 2016 ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices
• 2014 ASTM F1264-14 Standard Specification and Test Methods for Intramedullary Fixation Devices
• 2003 ASTM F1264-03(2012) Standard Specification and Test Methods for Intramedullary Fixation Devices
• 2007 ASTM F1264-03(2007)e2 Standard Specification and Test Methods for Intramedullary Fixation Devices
• 2007 ASTM F1264-03(2007)e1 Standard Specification and Test Methods for Intramedullary Fixation Devices
• 2003 ASTM F1264-03(2007) Standard Specification and Test Methods for Intramedullary Fixation Devices
• 2003 ASTM F1264-03 Standard Specification and Test Methods for Intramedullary Fixation Devices
• 2001 ASTM F1264-01 Standard Specification and Test Methods for Intramedullary Fixation Devices
• 2000 ASTM F1264-00 Standard Specification and Test Methods for Intramedullary Fixation Devices