Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

Importancia y uso:

4.1 Spinal implant constructs are typically a compilation of several components. Screws, plates, and rods are integral components of many spinal implant constructs. These components are designed to transfer load between the bone and the longitudinal or transverse element, or both. These specifications and test methods identify specifications for such components and define standard equivalent test methods that can be used when evaluating different related component designs.

4.2 Since the loading of spinal components in-vivo may differ from the loading configurations addressed in these specifications and test methods, the results obtained from this document may not predict in-vivo performance of either the components or the construct as a whole. Such tests can, however, be used to compare different component designs in terms of relevant mechanical performance characteristics.

4.3 The performance-related mechanical characteristics determined by these specifications and test methods will supply the user with information that may be used to predict the mechanical performance of different design variations of similar (function and indication) spinal construct components.

Subcomité:

F04.25

Referida por:

F3292-19, F3574-22

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

bend testing–plate; bend testing–rod; bend testing–screw; bend testing–surgical implants; fatigue test–plate; fatigue test–rod; fatigue test–screw; fatigue test–surgical implants; orthopedic medical device–plate; orthopedic medical device–rod; orthopedic medical device–screw; orthopedic spinal devices; performance; spinal arthrodesis; surgical devices; terminology; test methods–surgical implants;