This standard is issued under the fixed designation F2346; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (ε) indicates an editorial change since the last revision or reapproval.

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.

1.8

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.

1.9

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.

2. Referenced Documents

2.1 ASTM Standards:2

3. Terminology

3.1

3.2 Definitions:

4. Summary of Test Methods

4.1

4.2

4.3

4.4

4.5

4.6

5. Significance and Use

5.1

5.2

5.3

5.4

5.5

6. Apparatus

6.1

6.2

6.3 Axial Compression Test Apparatus:

6.4 Compression-Shear Testing Apparatus:

6.5 Torsion Testing Apparatus:

7. Sampling

7.1

7.2

7.3

7.4

7.5

8. Procedure for Static Tests

8.1

8.2

8.3

8.4

8.5

9. Procedure for Dynamic Tests

9.1

9.2

9.3

9.4

9.5

10. Analysis

10.1 Static Test Analyses:

10.2 Dynamic Test Analyses:

11. Report

11.1

11.2

11.3

11.4

12. Precision and Bias

12.1 Precision

12.2 Bias

13. Keywords

13.1

ASTM F2346 - 18

Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

Current

Published:

1 Jun 2018