Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: EN ISO 25539-2:2009
• Năm ban hành / Publication date: 2009
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
• Phạm vi áp dụng / Scope of standard: This part of ISO 25539 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.