1.1 This guide provides guidance for the development of in vitro test methods for measuring either radial strength or collapse pressure of balloon-expandable vascular stents and chronic outward force for self-expanding vascular stents. 1.2 This guide is applicable to balloon-expandable and self-expanding, cylindrical, single-axis stents. It does not cover axially tapered or bifurcated stents. It does not cover stents with noncircular cross sections. 1.3 This guide does not provide guidance for stents which significantly change length by greater than 10 % during the measurement of radial loading (that is, during compression or expansion within the apparatus). 1.4 Units--The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.5 This 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 may be used and recommends the format for presenting test results. 1.6 This guide covers only in vitro bench testing methods. In vivo behavior may be different. 1.7 This standard does not purport to address all of the testing 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.
The title and scope are in draft form and are under development within this ASTM Committee.
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