【国外标准】 Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems

3.1 This guide can be used to obtain force versus deflection or midspan bending moment versus midspan curvature curves for stents and stent systems subjected to three-point bending conditions. Bending flexibility of a stent system may be a factor in its ability to track through the vascular anatomy, and may be a factor in vascular trauma along the delivery pathway distal to the guide catheter. Bending flexibility of a deployed stent may be one measure of its ability to flex with a vessel, or to conform to the natural curvature of a vessel. Bending flexibility of a delivery system may also be of interest if it is desired to assess the separate contributions of the delivery system and the mounted stent to the overall flexibility of the stent system.3.2 This guide is not intended to determine material properties, stent system trackability (ability of a stent system to follow a guide wire and/or guide catheter through vascular tortuosity), or stent system deliverability (ability of a stent system to deliver a stent to the implantation site(s) or through particular level(s) of vascular tortuosity). While this guide does not determine stent system trackability or deliverability, it can provide quantitative insight into how stent system bending flexibility affects trackability and deliverability. Similarly, while this guide does not determine conformability of a deployed stent, it can provide quantitative insight into how stent and/or stent system bending flexibility affects deployed stent conformability. Since this guide quantifies bending flexibility, it may be useful in determining the magnitude of bending flexibility effects on bending-related performance differences between the test article and control devices.3.3 The three-point bending procedures provided in this guide are intended to be used to characterize balloon-expandable stent and stent system flexibility during product development. They may not necessarily satisfy any particular requirements of national or international regulatory bodies.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 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 non-vascular applications.1.4 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.1.5 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.