ASTM F2624-12(2020)
Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs

Standard No.

ASTM F2624-12(2020)

Release Date

2020

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2624-12(2020)

Scope

1.1 This test method describes methods to assess the static and dynamic properties of single level spinal constructs. 1.2 An option for assessing wear using a weight loss method and a dimensional analysis is given. This method, described herein, is used for the analysis of devices intended for motion preservation, using testing medium as defined in this standard (6.1). 1.3 This test method is not intended to address any potential failure mode as it relates to the fixation of the device to its bony interfaces. 1.4 It is the intent of this test method to enable single level extra-discal spinal constructs with regard to kinematic, functional, and wear characteristics when tested under the specified conditions. 1.5 This test method is not intended to address facet arthroplasty devices. 1.6 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures be established. This test method is intended to facilitate uniform testing methods and data reporting. 1.7 The motion profiles specified by this test method do not necessarily accurately reproduce those occurring in vivo. Rather this method provides useful boundary/endpoint conditions for evaluating implant designs in a functional manner. 1.8 This test method is not intended to be a performance standard. It is the responsibility of the user of this test method to characterize the safety and effectiveness of the device under evaluation. 1.9 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required. 1.10 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. No other units of measurement are included in this standard. 1.11 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. 1.12 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.

ASTM F2624-12(2020) Referenced Document

• ASTM E2309 Standard Practices for Verification of Displacement Measuring Systems and Devices Used in Material Testing Machines*， 2024-04-21 Update
• ASTM F1714 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• ASTM F1877 Standard Practice for Characterization of Particles
• ASTM F2003 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air*， 2022-11-15 Update
• ASTM F2423 Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
• ASTM F561 Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues

ASTM F2624-12(2020) history

• 2020 ASTM F2624-12(2020) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
• 2016 ASTM F2624-12(2016) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
• 2012 ASTM F2624-12 Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
• 2007 ASTM F2624-07 Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants