Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses


Importancia y uso:

4.1 This guide can be used to determine the fatigue and wear behavior of IVD prostheses subjected to functional and kinematic cyclic loading/motion for relatively large numbers of cycles (for example, various designs of IVD prostheses, as well as the effects of materials, manufacturing techniques and other design variables on one particular design can be determined using this guide).

4.2 This guide is intended to be applicable to IVD prostheses that support load and transmit motion by means of an articulating joint or by use of compliant materials. Ceramics, metals, or polymers, or combination thereof, are used in IVD prostheses, and it is the goal of this guide to enable a kinematic wear and/or fatigue comparison of these devices, regardless of material and type of device.

Subcomité:

F04.25

Referida por:

F3292-19, F2624-12R20, F2789-10R20, F3295-18, F2759-19, F2694-16R20

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

intervertebral disc prosthesis; IVD; spinal implants; wear assessment; weight loss method;

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Norma
F2423

Versión
11(2020)

Estatus
Active

Clasificación
Guide

Fecha aprobación
2020-10-01