ASTM F3295-18
Standard Guide for Impingement Testing of Total Disc Prostheses

Standard No.

ASTM F3295-18

Release Date

2018

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F3295-18

Scope

1.1 This standard is intended to provide guidance on the evaluation of wear and fatigue characteristics of total disc prostheses under cyclic impingement conditions. 1.2 This guide describes impingement testing of devices with articulating components. The user is cautioned that the methods described herein are intended to produce an impingement condition which may or may not be indicative of clinical performance and which may or may not be consistent with the intended use of the device, and that this should be considered when interpreting the data. Clinically, total disc prostheses should always be implanted per labeling and the manufacturer’s instructions for use. 1.3 Impingement has been observed in retrievals among several total disc prosthesis designs; however, impingement is not necessarily associated with device or clinical failure. It is the intent of this guide to investigate possible impingementinduced wear and mechanical failure modes associated with device design, as well as potential mechanical failure modes associated with clinical events such as subsidence, malpositioning, and improper implant sizing. Note that mechanical failure may or may not be associated with functional failure. 1.4 It is recommended that the user define the bearing and non-bearing features of the intervertebral disc (IVD) prosthesis and evaluate the performance of the IVD prosthesis under Mode 1 wear by using Guide F2423 or ISO 18192-1 prior to use of this guide. This standard is not intended to provide guidance on Mode I testing. 1.5 The goal of this guide is to evaluate impingement in IVD prostheses regardless of the intended region of the spine (cervical or lumbar), material or material combinations (ceramic, metal, polymer), and bearing type (fixed or mobile). 1.6 It is the intent of this guide to enable comparison of IVD prostheses with regard to wear and fatigue characteristics when tested under the specified conditions. 1.7 The values stated in SI units are to be regarded as the standard with the exception of angular measurements which should be reported in degrees. 1.8 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, 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.

ASTM F3295-18 Referenced Document

• ASTM E1402 Standard Terminology Relating to Sampling
• ASTM E1488 Standard Guide for Statistical Procedures to Use in Developing and Applying ASTM Test Methods
• ASTM E4 Standard Practices for Force Verification of Testing Machines
• ASTM F1714 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• ASTM F1877 Standard Practice for Characterization of Particles
• ASTM F2423 Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses*， 2020-10-01 Update
• ASTM F561 Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues

ASTM F3295-18 history

• 2018 ASTM F3295-18 Standard Guide for Impingement Testing of Total Disc Prostheses