心血管植入物 - 血管内装置 - 第2部分:血管支架

[中文适用范围]： 本文件规定了支架系统（血管支架和输送系统）的评估要求，以及根据当前医学知识对术语、设计属性和制造商提供的信息的要求。 体外测试方法的开发指南包含在附件 D 中。 本文件是 ISO 14630 的补充，它规定了非活性手术植入物性能的一般要求。 注 1：由于本文件涵盖的植入物设计存在差异，并且在某些情况下由于此类植入物新型类型的出现，可接受的标准化体外测试和临床结果并不总是可用。 随着进一步的科学和临床数据的出现，有必要对本文件进行适当的修订。 本文件适用于用于治疗血管狭窄或其他血管异常或病变的血管支架和血管支架（例如可吸收血管支架）。 有些要求是针对动脉狭窄的血管内治疗的。 尽管支架系统除了治疗动脉狭窄（例如静脉支架置入）之外的用途也在本文件的范围内，但没有描述这些用途的综合要求和测试。 类似地，特定支架配置（例如分叉支架）也在范围内，但没有描述这些装置的综合要求和测试。 与血管内假体组合使用以完成病变治疗的支架，包括桥接支架（例如，在有孔血管内假体展开后放置在肾动脉中的支架）均在本文件的范围内，但未描述测试方法对于组合。 ISO 25539-1 还提供了与此类支架的临床前体内和临床评估相关的信息。 具有表面修饰（例如药物和/或其他涂层）的血管支架在本文件的范围内。 覆盖有显着改变未覆盖支架的渗透性的材料（例如通过覆盖无支架表面区域）的支架属于 ISO 25539-1 的范围。 支架设计或预期用途可能决定需要满足 ISO 25539-1 和本文件中确定的功能要求（例如与血管内假体结合使用的支架、用于治疗主动脉瘤的支架）。 与支架系统集成的球囊在本文件的范围内。 本文件提供了超出 ISO 10555-4 要求的要求，ISO 10555-4 专门针对带有血管支架的球囊的使用。 本文件不适用于引入血管支架之前使用的程序和设备，例如球囊血管成形术设备。 用于现场治疗血管成形术后解剖的定位装置、线圈支撑装置和分流器都在本文件的范围内，但没有描述这些装置的综合要求和测试。 尽管药物洗脱支架在本文件的范围内，但本文件对于这些装置的药物洗脱特性并不全面。 注 2：血管器械-药物组合产品属于 ISO 12417-1 的范围。  虽然可吸收支架和具有可吸收涂层的支架在本文件的范围内，但本文件对于这些装置的可吸收特性并不全面。 注 3：可吸收植入物在 ISO/TS 17137 的范围内。 虽然涂层支架和涂层支架系统在本文件的范围内，但本文件在涂层方面并不全面。 注 4：某些涂层特性在 ISO 17327-1 的范围内。 本文件不涉及用于构建血管支架的活组织和非活生物材料的要求和评估。 [外文原描述]： This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this document will be necessary. This document is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this document, comprehensive requirements and testing are not described for these uses. Similarly, specific stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and testing are not described for these devices. Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated endovascular prosthesis), are within the scope of this document, but test methods are not described for the combination. ISO 25539-1 also provides information relevant to the preclinical in vivo and clinical evaluations of such stents. Vascular stents that have surface modifications, such as drug and/or other coatings, are within the scope of this document. Stents covered with materials that significantly modify the permeability of the uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The stent design or intended use might dictate the need to address functional requirements identified in both ISO 25539-1 and this document (e.g. stents used in combination with endovascular prostheses, stents used to treat aortic aneurysms). Balloons integral to the stent system are within the scope of this document. This document provides requirements beyond the requirements of ISO 10555-4, which are specific to the use of balloons with vascular stents. This document is not applicable to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices. Tacking devices intended to spot treat post-angioplasty dissections, coil supporting devices, and flow diverters are within the scope of this document, but comprehensive requirements and testing are not described for these devices. Although drug-eluting stents are within the scope of this document, this document is not comprehensive with respect to the drug-eluting properties of these devices. NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417-1. Although absorbable stents and stents with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these devices. NOTE 3 Absorbable implants are within the scope of ISO/TS 17137. Although coated stents and coated stent systems are within the scope of this document, this document is not comprehensive with respect to coatings. NOTE 4 Some coating properties are within the scope of ISO 17327-1. This document does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of vascular stents.