Standard Practice for Inspection of Spinal Implants Undergoing Testing

Abstract

5.1 ASTM standards under the jurisdiction of Subcommittee F04.25 (such as Test Methods F1717, F1798, F2077, F2267, F2346, F2624, F2706, F3574, and F3631; Specifications and Test Methods F2193; Guides F2423, F2789, and F3295; Practices F2694 and F2790) describe test methods and prescribe guidelines for evaluating different types of spinal implants. Adherence to many of these standards may result in mechanical failure. In some cases, however, the failure may not be obvious. This practice provides guidelines for inspection such that the end user can effectively identify and characterize physical changes in test parts. 5.2 The reporting of a mechanical failure and/or changes in device characteristics is one source of error in precision and bias. Varying levels and types of characterization have the potential to affect data reporting. This practice may reduce bias by providing guidance that can aid in effectively analyzing changes in test parts. 5.3 Nondestructive evaluation allows continued testing of a specimen if performed mid-test and preserves the specimen for post-test examination. Examination may also be limited to nondestructive evaluation in a limited permission environment.