標準號：ANSI/AAMI/ISO 25539-2-2012
中文標準名稱：心血管植入物.血管內器械.第2部分:血管支架
英文標準名稱：Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
標準類型：C45
發布日期：2012/12/3 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C45
適用范圍：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.