ANSI/AAMI/ISO 25539-2-2012 心血管植入物.血管内器械.第2部分:血管支架

标准号：ANSI/AAMI/ISO 25539-2-2012
中文标准名称：心血管植入物.血管内器械.第2部分:血管支架
英文标准名称：Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
标准类型：C45
发布日期：2012/12/3 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C45
适用范围：Specifies requirements for vascular stents, based upon current medical knowledge. Gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. Includes vascular stents used to treat vascular lesions or stenosis, or other vascular abnormalities. These devices may or may not incorporate surface modifications of the stent such as drug and/or other coatings.