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1.1 Purpose—This guide establishes recommendations and considerations for the development, verification, validation, and reporting of structural finite element models used in the evaluation of the performance of a metallic vascular stent design undergoing uniform radial loading. This standard guide does not directly apply to non-metallic or absorbable stents, though many aspects of it may be applicable. The purpose of a structural analysis of a stent is to determine quantities such as the displacements, stresses, and strains within a device resulting from external loading, such as crimping or during the catheter loading process, and in-vivo processes, such as expansion and pulsatile loading.

1.2 Limitations—The analysis technique discussed in this guide is restricted to structural analysis using the finite element method. This document provides specific guidance for verification and validation (V&V) of finite element (FE) models of vascular stents subjected to uniform radial loading using ASME V&V40 as the basis for developing and executing risk-informed V&V plans.

1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for informational purposes only.

1.4 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.

4.1 Finite element analysis is a valuable tool for evaluating the performance of metallic stents and in estimating quantities such as stress, strain, and displacement due to applied external loads and boundary conditions. FEA of stents is frequently performed to determine the worst-case size for experimental fatigue (or durability) testing and differentiation of performance between designs. A finite element analysis is especially valuable in determining quantities that cannot be readily measured.