1.1 本指南介绍了作为血管内器械保质期研究的一部分，确定用于测试的适当器械属性。组合和可生物降解装置（例如，药物装置、生物装置或药物生物制品）可能需要额外考虑，具体取决于其性质。 1.2 本指南没有直接提供任何进行保质期测试的测试方法。 1.3 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。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 3.1 本指南的目的是提供一种程序，用于确定在血管内装置的保质期研究中评估的适当属性。

1.1 This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example, drug devices, biologic devices, or drug biologics) may require additional considerations, depending on their nature. 1.2 This guide does not directly provide any test methods for conducting shelf-life testing. 1.3 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. 1.4 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. ====== Significance And Use ====== 3.1 The purpose of this guide is to provide a procedure for determining the appropriate attributes to evaluate in a shelf-life study for an endovascular device.