ASTM F2267-22
Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

Standard No.

ASTM F2267-22

Release Date

2022

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2267-22

Scope

1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment. 1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion devices. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices. 1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test method is designed to allow for the comparative evaluation of intervertebral body fusion devices. 1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices. 1.5 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer’s recommended usage. 1.6 Units—The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians. 1.7 The use of this standard may involve the operation of potentially hazardous equipment. 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. 1.8 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 F2267-22 Referenced Document

• ASTM E177 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• ASTM E4 Standard Practices for Force Verification of Testing Machines
• ASTM E691 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• ASTM F1582 Standard Terminology Relating to Spinal Implants
• ASTM F1839 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
• ASTM F2077 Standard Test Methods for Intervertebral Body Fusion Devices

ASTM F2267-22 history

• 2022 ASTM F2267-22 Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
• 2018 ASTM F2267-04(2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
• 2011 ASTM F2267-04(2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
• 2004 ASTM F2267-04 Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
• 2003 ASTM F2267-03 Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression