ASTM F3292-19 - Standard Practice for Inspection of Spinal Implants Undergoing Testing
Standard Practice for Inspection of Spinal Implants Undergoing Testing
| Standard number: | ASTM F3292-19 |
| Released: | 01.03.2019 |
| Status: | Active |
| Pages: | 4 |
| Section: | 13.02 |
| Keywords: | cervical; extra-discal spinal constructs; fatigue test methods; intervertebral body fusion device; intervertebral disc prosthesis; lumbar; lumbar facet prosthesis; lumbosacral; nucleus devices; occipital-cervical-thoracic spinal implant construct; spinal arthrodesis; spinal artificial disc; spinal devices; spinal implant assembly; spinal implant construct; static test methods; subsidence; thoracic; thoracolumbar pedicle screw system; total disc prosthesis; vertebrectomy; wear; |
1.1 This practice provides guidance for non-destructive photographic analysis of spinal implants prior to, during, and after testing. The purpose of this practice is to provide methods for documenting notable changes in implant characteristics (e.g., surface defects, cracks, plastic deformation) that have occurred during the course of a mechanical test. Documenting these changes may assist in understanding if mechanical failure has occurred, and how.
1.2 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.