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Significance and Use
5.1 ASTM standards under the jurisdiction of Subcommittee F04.25 (such as, Test Methods , , , , , , and , Specifications and Test Methods , Guides and , Practices and ) describe test methods and prescribe guidelines for evaluating different types of spinal implants (as defined in Terminology ). 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F1582 Terminology Relating to Spinal Implants
F1717 Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
F1798 Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
F2077 Test Methods For Intervertebral Body Fusion Devices
F2193 Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
F2267 Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
F2346 Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
F2423 Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
F2624 Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
F2694 Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
F2706 Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
F2789 Guide for Mechanical and Functional Characterization of Nucleus Devices
F2790 Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses
ICS Number Code 11.040.40 (Implants for surgery, prosthetics and orthotics)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F3292-19, Standard Practice for Inspection of Spinal Implants Undergoing Testing, ASTM International, West Conshohocken, PA, 2019, www.astm.orgBack to Top