1.1 本指南为测试前处理、测试和测试端点的设计和开发提供指导，以测量预安装、无外壳、球囊可膨胀支架输送系统的支架固定。本指南旨在帮助研究人员进行设计、开发和 体外 预安装、无外壳、球囊扩张支架输送系统的特性。 1.2 本指南涵盖了实验室测定移位或移除安装在输送系统上的球囊可膨胀血管内支架所需的剪切力。该指南提出了一组测试支架固定时需要考虑的选项。选项包括试验前治疗、可能的支架固定试验和相关试验终点。试验装置示例见 7.1 . 1.3 本指南涵盖 体外 仅用于台架试验表征。所测量的固定水平和产品设计/工艺差异可能特别受测试前处理、固定测试类型（例如支架夹持方法）和测试终点选择的影响。 体内 特征也可能不同于 体外 后果 1.4 本指南未涵盖所有可能的试验前治疗、支架固定试验或试验终点。它旨在提供一个起点，从中选择和研究固定测试选项。 1.5 本指南未规定将支架安装到输送系统上的方法。 1.6 以国际单位或英寸-磅单位表示的数值应单独视为标准值。每个系统中所述的值不一定精确相等； 因此，为了确保符合标准，每个系统应独立于另一个系统使用，并且两个系统的值不应合并。 1.7 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者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。 1.8 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 球囊上血管内支架的固定是确保支架安全运送至治疗部位或从治疗部位运出的关键参数。 4.2 本指南旨在供研究人员和制造商用于制定和选择测试前处理、测试和测试终点，以测量支架固定（位移距离和位移力）。 4.3 本指南可用于调查 体外 测试最能描述临床情况。 4.4 由于临床条件、失效模式和支架输送系统设计的多种可能组合，在选择固定试验和评估结果时应谨慎使用本指南。 4.5 本指南可用于制定符合EN 14299第7节第2部分和第3部分要求的试验。 3.4.4可跟踪性。 4.6 本指南可用于制定符合CDRH指南文件第VII-C-8节要求的测试。

1.1 This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems. 1.2 This guide covers the laboratory determination of the shear force required to displace or dislodge a balloon-expandable endovascular stent mounted on a delivery system. The guide proposes a set of options to consider when testing stent securement. The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. An example test apparatus is given in 7.1 . 1.3 This guide covers in vitro bench testing characterization only. Measured levels of securement and product design/process differentiation may be particularly influenced by selections of pre-test treatments, securement test type (for example, stent gripping method), and test endpoint. In vivo characteristics may also differ from in vitro results. 1.4 This guide does not cover all possible pre-test treatments, stent securement tests, or test endpoints. It is intended to provide a starting point from which to select and investigate securement test options. 1.5 This guide does not specify a method for mounting the stent onto the delivery system. 1.6 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 1.7 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. 1.8 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 The securement of the endovascular stent on the balloon is a critical parameter to ensure that the stent is safely delivered to or from the treatment site. 4.2 This guide is intended for use by researchers and manufacturers for the development and selection of pre-test treatments, tests, and test endpoints to measure stent securement (displacement distances and dislodgment forces). 4.3 This guide may be used to investigate which practical combinations of in vitro tests best characterize clinical scenarios. 4.4 This guide should be used with discretion in choosing securement tests and evaluating results due to the myriad possible combinations of clinical conditions, failure modes, and stent delivery system designs. 4.5 This guide may be of use for developing a test for meeting Parts 2 and 3 of the requirements of EN 14299, Section 7.3.4.4 on Trackability. 4.6 This guide may be of use for developing a test to meet section VII-C-8 of CDRH Guidance document.