中文名称: 动脉球囊扩张支架和支架系统三点挠度指南 |
英文名称:Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems |
中标分类:C45 | ICS分类:11.040.40 |
标准分类编号:AS | 页数:6 |
发布日期: | 实施日期:2008-10-01 | 作废日期: |
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范围:1.1 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. 1.2 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. 1.3 This guide does not provide procedures for characterizing the bending flexibility of self-expanding stents, self-expanding 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 dev |
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