标准摘要
[中文适用范围]： 本文件规定了 ISO 17327-1:2018 在涂层血管内假体、血管支架和腔静脉过滤器中的适当应用。 本文件旨在用作补充 以下涂层属于 ISO 17327-1 的范围，并在本文件中针对血管内器械进行讨论：药物涂层（洗脱和非洗脱）、非药物涂层（可吸收和非吸收）可吸收），以及与化学相关的表面改性（氧化物，例如 TiO2，和非氧化物，例如非晶碳化硅和类金刚石碳）。 本文件不适用于带涂层的输送系统或带涂层的辅助装置（例如导丝），因为这些涂层不在专门针对植入物涂层的 ISO 17327-1 的范围内。 本文件不适用于血管内装置的覆盖物；然而，如果设备的覆盖物被涂覆，则其在本文件的范围内。 本文件不涉及用作植入物涂层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 the appropriate application of ISO 17327-1:2018 to coated endovascular prostheses, vascular stents, and vena cava filters. This document is intended to be used as a supplement to ISO 25539-1, ISO 25539-2, ISO 25539-3, ISO 12417-1 and ISO/TS 17137. The following coatings are within the scope of ISO 17327-1 and addressed in this document for endovascular devices: drug coatings (eluting and non-eluting), non-drug coatings (absorbable and non-absorbable), and chemistry-related surface modifications (oxide, such as TiO 2 , and non-oxide, such as amorphous silicon carbide and diamond-like carbon). This document is not applicable to coated delivery systems or coated ancillary devices (e.g. guidewires), as these coatings are not within the scope of ISO 17327-1, which is specifically directed to implant coatings. This document is not applicable to coverings of endovascular devices; however, if the covering of a device is coated, it is within the scope of this document. This document does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used as implant coatings.
英文名称Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices