标准编号：ISO 25539-2:2020
中文名称：心血管植入物 血管内装置 第2部分：血管支架
英文名称：Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
发布日期：2020-09
标准范围
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.
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