1.1 本文件为开发 体外 测量球囊可膨胀血管支架的径向强度或塌陷压力和自膨胀血管支架的慢性向外力的试验方法。 1.2 本指南适用于管状几何形状的球囊扩张支架和自扩张支架。它包括支架和支架移植物。它不包括分叉支架。它不包括非圆形截面的支架或锥形支架。 1.3 单位- 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.4 本指南不推荐用于测量径向强度、坍塌压力或慢性外力的任何特定试验方法或装置。相反，本指南提供了可以使用的测试方法和设备的示例，并推荐了呈现测试结果的格式。 1.5 本指南仅涵盖 体外 台架试验方法。 体内 行为可能不同。 1.6 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 部署后，在血管狭窄部位，支架建立管腔通畅性，直到血管重塑发生。作用在支架上的径向载荷由血管和病变拉伸施加。 此外，血管可能会受到脉动（收缩和舒张变化）引起的漂移、患者运动引起的肌肉-骨骼相互作用以及外部来源（例如，患者在车祸中被击中颈部）的影响。漂移的大小和类型因船舶位置而异。 4.2 为了保持血管通畅，支架必须承受作用在其上的力，而不会发生过度变形、移动或持续塌陷；因此，要求支架对这些载荷具有足够的阻力。 4.3 根据设备类型和临床问题，可以通过多种测试输出来表示对这些负载的阻力:径向强度、坍塌压力或慢性外力。 4.4 本文提出的指南可用于制定测试方法，以确定支架的径向负荷特性。 本指南提供了不同测试仪器（设备和工具）、径向负载曲线和计算的示例。虽然所提出的仪器和方法可以作为实际临床应用的合理模拟，但尚未证明它们可以预测实际的临床应用 体内 任何支架的临床性能。

1.1 This document provides guidance for developing in vitro test methods for measuring the radial strength or collapse pressure of balloon-expandable vascular stents and chronic outward force of self-expanding vascular stents. 1.2 This guide is applicable to balloon-expandable and self-expanding stents of tubular geometry. It covers both stent and stent grafts. It does not cover bifurcated stents. It does not cover stents with non-circular cross sections or tapered stents. 1.3 Units— The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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 could be used and recommends the format for presenting test results. 1.5 This guide covers only in vitro bench testing methods. In vivo behavior might be different. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 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. ====== Significance And Use ====== 4.1 Upon deployment, at the site of the vascular stenosis, the stent establishes the patency of the lumen until vascular remodeling occurs. The radial load acting upon the stent is imparted by vessel and lesion stretch. Additionally, the vessel might be affected by excursions due to pulsation (systolic and diastolic variation), muscle-skeletal interactions due to patient movement, as well as external sources (e.g., patient is struck in the neck during a car accident). The excursions vary in magnitude and type based on the location of the vessel. 4.2 In order to maintain vessel patency, the stent has to withstand the forces acting on it without experiencing excessive deformation, migration, or sustained collapse; therefore, it is required that the stent possess adequate resistance to these loads. 4.3 Depending on the type of device and the clinical concern, the resistance to these loads can be presented through multiple test outputs: radial strength, collapse pressure, or chronic outward force. 4.4 The guidelines presented here can be used in the development of test methods to determine the radial loading properties of stents. This guide provides examples of different test apparatus (equipment and tooling), radial loading curves, and calculations. Although the apparatus and methods presented can be used as a reasonable simulation of actual clinical use, they have not been demonstrated to predict the actual in vivo clinical performance of any stent.