1.1This document provides guidance for developing in vitro test methods for measuring the radial strength or collapse pressure of balloon-expandable vascular stents and chronic outward force of self-expanding vascular stents.
1.2This guide is applicable to balloon-expandable and self-expanding stents of tubular geometry. It covers both stent and stent grafts. It does not cover bifurcated stents. It does not cover stents with non-circular cross-sections or tapered stents.
1.3Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4This guide does not recommend any specific test method or apparatus for measuring the radial strength, collapse pressure, or chronic outward force. Instead, this guide provides examples of test methodologies and equipment that could be used and recommends the format for presenting test results.
1.5This guide covers only in vitro bench testing methods. In vivo behavior might be different.
1.6This 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 and health practices and determine the applicability of regulatory limitations prior to use.