1.1 这些测试方法包括通过流体动力学脉冲载荷使血管支架或内假体暴露于径向变形来确定其耐用性。该测试在已部署到模拟（弹性模拟）容器中的测试样品上进行。该测试进行了多个循环，以充分确定样品的预期抗疲劳性。 1.2 这些测试方法适用于由金属和金属合金制成的球囊扩张和自扩张支架以及带有金属支架的血管内假体。本标准没有具体说明涂层支架、聚合物支架或可生物降解支架的任何独特属性，尽管不排除将该测试方法应用于这些产品。 1.3 这些测试方法可用于评估支架和血管内假体在暴露于血管周期性直径变化时的耐用性。 这些测试方法不涉及其他循环加载模式，如弯曲、扭转、拉伸或压缩。 1.4 这些测试方法主要用于生理相关的直径变化，但为超生理直径变形（即疲劳断裂）提供了指导。 1.5 这些测试方法确实解决了弯曲模拟船的测试条件，但可能无法解决所有问题。 1.6 以国际单位制表示的值应被视为标准值。本标准不包括其他计量单位。 1.7 本标准并不旨在解决与其使用相关的所有安全问题（如果有的话）。本标准的使用者有责任在使用前建立适当的安全、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。

1.1 These test methods cover the determination of the durability of a vascular stent or endoprosthesis by exposing it to diametric deformation by means of hydrodynamic pulsatile loading. This testing occurs on a test sample that has been deployed into a mock (elastically simulated) vessel. The test is conducted for a number of cycles to adequately establish the intended fatigue resistance of the sample. 1.2 These test methods are applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys and endovascular prostheses with metal stents. This standard does not specifically address any attributes unique to coated stents, polymeric stents, or biodegradable stents, although the application of this test method to those products is not precluded. 1.3 These test methods may be used for assessing stent and endovascular prosthesis durability when exposed to blood vessel cyclic diametric change. These test methods do not address other cyclic loading modes such as bending, torsion, extension, or compression. 1.4 These test methods are primarily intended for use with physiologically relevant diametric change, however guidance is provided for hyper-physiologic diametric deformation (that is, fatigue to fracture). 1.5 These test methods do address test conditions for curved mock vessels, however might not address all concerns. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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.