ASTM F2694-07
Historical Standard: ASTM F2694-07 Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
SUPERSEDED (see Active link, below)
ASTM F2694
1. Scope
1.1 This practice provides guidance for the functional, kinematic and wear testing of motion-preserving total facet prostheses for the lumbar spine. These implants are intended to allow motion and lend support to the functional spinal unit(s) through replacement of the natural facets.
1.2 This test method is not intended to address the bone implant interface or the static characteristics of the prosthesis components. Fatigue characteristics are included, but only as a by-product of cyclic wear testing under facet load and thus are not addressed in the typical process of generating an S-N characterization.
1.3 Biocompatibility of the materials used in a total facet prosthesis are not addressed in this practice.
1.4 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in either degrees or radians.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
F1714 Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
F1877 Practice for Characterization of Particles
F2346 Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
Keywords
dynamic test; facet arthroplasty; posterior instrumentation; spinal implants; static test; wear assessment; weight loss method;
ICS Code
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
DOI: 10.1520/F2694-07
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