1. Scope

1.1 These test methods specify the materials and methods for the static and dynamic testing of artificial intervertebral discs.

1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic artificial intervertebral discs. These test methods allow comparison of artificial intervertebral discs with different intended spinal locations (cervical, thoracic, and lumbar) and methods of application to the intervertebral spaces. These test methods are intended to enable the user to mechanically compare artificial intervertebral discs and do not purport to provide performance standards for artificial intervertebral discs.

1.3 These test methods describe static and dynamic tests by specifying load types and specific methods of applying these loads. These tests are designed to allow for the comparative evaluation of artificial intervertebral discs.

1.4 These test methods do not purport to address all clinically relevant failure modes for artificial intervertebral discs, some of which will be device specific. For example, these test methods do not address the implant's resistance to expulsion or implant wear resistance under expected in vivo loads and motions. In addition, the biologic response to wear debris is not addressed in these test methods.

1.5 Requirements are established for measuring displacements, determining the yield load or moment, and evaluating the stiffness of artificial intervertebral discs.

1.6 Some artificial intervertebral discs may not be testable in all test configurations.

1.7 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.

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 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

E4 Practices for Force Verification of Testing Machines

E6 Terminology Relating to Methods of Mechanical Testing

E466 Practice for Conducting Force Controlled Constant Amplitude Axial Fatigue Tests of Metallic Materials

E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System

E468 Practice for Presentation of Constant Amplitude Fatigue Test Results for Metallic Materials

E1823 Terminology Relating to Fatigue and Fracture Testing

F1582 Terminology Relating to Spinal Implants

F2077 Test Methods For Intervertebral Body Fusion Devices

Keywords

artificial intervertebral disc; dynamic test methods; spinal implants; static test methods;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F2346-05

ASTM International is a member of CrossRef.