Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems
|Publication Date:||1 October 2008|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This guide provides guidelines for quantitatively characterizing balloon-expandable stent and stent system flexibility using three-point bending procedures. Guidelines are provided for characterizing deployed stent flexibility, and for characterizing pre-deployment stent system flexibility in the region of the stent and balloon.
This guide is not recommended for test articles that cannot be appropriately evaluated using a span length to stent outer diameter (as tested) ratio of at least 4:1. Test articles that do not meet this requirement are likely to exhibit appreciable deformation by modes other than bending.
This guide does not provide procedures for characterizing the bending flexibility of self-expanding stents, selfexpanding stent systems, endoprostheses (stent-grafts), or endoprostheses systems. However, some aspects of this guide may be useful for developing appropriate three-point bending characterization procedures for these devices. While this guide was developed with vascular stents and stent systems in mind, it may be useful for characterizing the bending flexibility of balloon-expandable stents and stent systems used in nonvascular applications.
The values stated in SI units are to be regarded as the standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.