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 This specification includes four standard test methods:

1.3.1 Static Four-Point Bend Test Method Annex A1 and

1.3.2 Static Torsion Test Method Annex A2.

1.3.3 Bending Fatigue Test Method Annex A3.

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

1.4 A rationale is given in Appendix X1.

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

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

A214/A214M Specification for Electric-Resistance-Welded Carbon Steel Heat-Exchanger and Condenser Tubes

A450/A450M Specification for General Requirements for Carbon and Low Alloy Steel Tubes

D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

E4 Practices for Force Verification of Testing Machines

E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System

E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

E1823 Terminology Relating to Fatigue and Fracture Testing

F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants

F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

F339 Specification for Cloverleaf Intramedullary Pins

F543 Specification and Test Methods for Metallic Medical Bone Screws

F565 Practice for Care and Handling of Orthopedic Implants and Instruments

F1611 Specification for Intramedullary Reamers

AMS Standard

SAE Standard

Keywords

bend testing; definitions; extraction; fatigue test; fracture fixation; implants; intramedullary fixation devices; orthopaedic medical device; performance; surgical devices; terminology; test methods; torsion test; trauma;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F1264-03R07E02

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