1.1 本指南涵盖了血管支架尺寸属性的识别和推荐测量方法，这些尺寸属性被认为与成功的临床表现相关。本指南的范围还包括专门为支架放置过程中使用而包装和标记的输送系统。 1.2 本指南仅针对 维度的 支架的特点。材料特性和支架功能特性在此不作说明。本指南中描述的所有尺寸特征均指 体外 （“台面”）特征。由于患者因素可变，例如血管顺应性 体内 特征可能略有不同。 1.3 本指南包括通常适用于由金属和金属合金制成的球囊可膨胀和自膨胀支架的建议。虽然本指南并不排除对涂层支架或聚合物或生物降解支架的任何独特属性的应用，但本指南并未具体说明这些产品的独特属性。 1.4 虽然这些支架没有具体包括在本指南的范围内，但用于非血管位置（如食管或胆管）的支架也可能具有本文所含方法的特征。同样，本指南不包括血管内移植物（“支架- 移植物”）或通常用于治疗动脉瘤疾病或周围血管创伤或提供血管通路的其他导管装置，尽管本文包含的一些信息可能适用于这些装置。 1.5 本指南不包括作为独立血管成形术导管销售的球囊导管的建议，尽管其中一些导管可能用于输送未安装支架，但无需输送系统。血管成形术导管的要求包含在标准ISO 10555-1和ISO 10555-4中。 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。 1.6.1 本指南中使用的计量单位反映了截至本指南最初批准时，美国临床上常用的混合系统。由于本指南的主要目的是促进标签的一致性，以便于临床用户选择器械，因此本指南选择了用户最喜欢的单位。如果这些单位不是国际单位或其衍生物，则在括号中提供国际单位。 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 血管支架用于永久性植入人体血管系统（天然或移植），以保持血管通畅。血管支架的尺寸属性是帮助临床医生为个体患者选择设备的关键参数。本指南列出了与这些设备的临床实用性和性能直接相关的维度属性，以及测量这些属性的一致方法的建议，并提供了用于临床决策的信息。支架制造商和研究人员可以使用本指南来提供这些尺寸特征的测量和标签的一致性。 它可能在有关当局对这些装置的监管中有用途。 4.2 本指南中包括的尺寸属性是根据先前临床经验认为与支架临床性能成功相关或可能预测支架临床性能的属性；然而，由于影响任何个体治疗临床结果的无数患者和医疗因素，支架和输送系统是否符合本指南中的建议不应被解释为任何个体患者或患者群体临床成功的保证。

1.1 This guide covers the identification of and recommended measurement methods for those dimensional attributes of vascular stents that are deemed relevant to successful clinical performance. The delivery system packaged with and labeled specifically for use during the placement of the stent is also included within the scope of this guide. 1.2 This guide addresses only the dimensional characteristics of stents. Material property and stent functional characteristics are not addressed herein. All dimensional characteristics described in this guide refer to in vitro (“bench-top”) characterization. Because of variable patient factors, for example, vessel compliance, the actual in vivo characteristics may be slightly different. 1.3 This guide includes recommendations generally applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents or polymeric or biodegradable stents, although the application of this guide to those products is not precluded. 1.4 While they are not specifically included within the scope of this guide, stents indicated for placement in nonvascular locations, such as the esophagus or bile duct, also might be characterized by the methods contained herein. Likewise, this guide does not include recommendations for endovascular grafts (“stent-grafts”) or other conduit devices commonly used to treat aneurysmal disease or peripheral vessel trauma or to provide vascular access, although some information included herein may be applicable to those devices. 1.5 This guide does not include recommendations for balloon catheters sold as stand-alone angioplasty catheters, even though some of those catheters may be used for the delivery of unmounted stents supplied without a delivery system. Requirements for angioplasty catheters are contained in standards ISO 10555-1 and ISO 10555-4. 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. 1.6.1 The units of measurements used throughout this guide reflect the hybrid system in common clinical use in the United States as of the time of the original approval of this guide. Since a primary purpose of this guide is to promote uniformity of labeling to facilitate the selection of devices by clinical users, the units most preferred by users were selected for this guide. Where those units are not SI units, or derivatives thereof, SI units are provided in parentheses. 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 Vascular stents are intended for permanent implant in the human vasculature (native or graft) for the purposes of maintaining vessel patency. The dimensional attributes of vascular stents are critical parameters that aid clinicians in the selection of devices for individual patients. This guide contains a listing of those dimensional attributes that are directly related to the clinical utility and performance of these devices, along with recommendations for consistent methods of measuring these attributes and presenting the information for use in clinical decision making. This guide can be used by the manufacturers and researchers of stents to provide consistency of measurement and labeling of these dimensional characteristics. It may have use in the regulation of these devices by appropriate authorities. 4.2 The dimensional attributes included in this guide are those that are deemed related to or possibly predictive of successful clinical performance of the stent based on prior clinical experience; however, because of the myriad patient and medical factors that influence the clinical outcome of any individual treatment, conformance of a stent and delivery system with the recommendations in this guide should not be interpreted as a guarantee of clinical success in any individual patient or group of patients.