【国外标准】 Standard Practice for Inspection of Spinal Implants Undergoing Testing

5.1 ASTM standards under the jurisdiction of Subcommittee F04.25 (such as, Test Methods F1717, F1798, F2077, F2267, F2346, F2624, and F2706, Specifications and Test Methods F2193, Guides F2423 and F2789, Practices F2694 and F2790) describe test methods and prescribe guidelines for evaluating different types of spinal implants (as defined in Terminology F1582). Adherence to many of these standards may result in mechanical failure. In some cases, however, the failure may not be obvious. Because none of these standards discuss, describe, or provide methods for inspecting the devices for failure, 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 Non-destructive 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 non-destructive evaluation in a limited permission environment.1.1 This practice provides guidance for non-destructive photographic analysis of spinal implants prior to, during, and after testing. The purpose of this practice is to provide methods for documenting notable changes in implant characteristics (e.g., surface defects, cracks, plastic deformation) that have occurred during the course of a mechanical test. Documenting these changes may assist in understanding if mechanical failure has occurred, and how.1.2 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.1.3 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.