ISO 25539-2:2008 心血管植入物 血管内器械 第2部分：血管支架
标准编号：ISO 25539-2:2008
中文名称：心血管植入物 血管内器械 第2部分：血管支架
英文名称：Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
发布日期：2008-09
标准范围
ISO 25539-2:2008根据当前医学知识规定了血管支架的要求。在安全方面，它对预期性能、设计属性、材料、设计评估、制造、灭菌包装和制造商提供的信息提出了要求。应将其视为ISO 14630的补充，ISO 14630规定了非活性外科植入物性能的一般要求。ISO 25539-2:2008的范围包括用于治疗血管病变或狭窄或其他血管异常的血管支架。这些装置可能包含也可能不包含支架的表面修饰，例如药物和/或其他涂层。覆盖有显著改变未覆盖支架渗透性的材料的支架符合ISO 25539-1:2003的范围。支架设计可能要求满足ISO 25539-1:2003和ISO 25539-2:2008中确定的功能要求。ISO 25539-2:2008中包括输送系统，前提是它们是血管支架部署的一个组成部分。ISO 25539阐述了药物洗脱支架的一些药理学方面-2:2008，但本文件对药物洗脱支架的药理学评估并不全面。除灭菌外，ISO 25539-2:2008未涉及动物组织产品评估的要求。
ISO 25539-2:2008 specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.The scope of ISO 25539-2:2008 includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices might or might not incorporate surface modifications of the stent such as drug and/or other coatings. Stents covered with materials that significantly modify the permeability of the uncovered stent are within the scope of ISO 25539-1:2003. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1:2003 and ISO 25539-2:2008.Delivery systems are included in ISO 25539-2:2008 if they comprise an integral component of the deployment of the vascular stent.Some pharmacological aspects of drug eluting stents are addressed in ISO 25539-2:2008, but this document is not comprehensive with respect to the pharmacological evaluation of drug eluting stents.With the exception of sterilization, ISO 25539-2:2008 does not address requirements for the evaluation of animal tissue products.
标准预览图
