ISO 25539-4:2021 心血管植入物 血管内装置 第4部分：ISO 17327-1对涂层血管内装置的应用
标准编号：ISO 25539-4:2021
中文名称：心血管植入物 血管内装置 第4部分：ISO 17327-1对涂层血管内装置的应用
英文名称：Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices
发布日期：2021-11
标准范围
本文件规定了ISO的适当应用？17327-1:20 18涂层血管内假体、血管支架和腔静脉过滤器。本文件旨在作为ISO？25539-1，ISO？25539-2，ISO？25539-3，ISO？12417-1和ISO/TS？17137.以下涂料在ISO范围内？17327-1，并且在本文件中针对血管内装置阐述了药物涂层(洗脱和非洗脱)、非药物涂层(可吸收和不可吸收)和化学相关的表面改性(氧化物，例如TiO2和非氧化物，例如无定形碳化硅和类金刚石碳)。本文件不适用于涂层输送系统或涂层辅助器械（如导丝），因为这些涂层不在ISO？17327-1，其具体涉及植入物涂层。本文件不适用于血管内器械的覆盖物；然而，如果装置的覆盖物被涂覆，则在本文件的范围内。本文件未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价。
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 TiO2, 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.
标准预览图
