YY/T 0663-2008《无源外科植入物—心脏和血管植入物的特殊要求—动脉支架的专用要求》标准解析

Guidance and Analyzation for the Standard of YY/T 0663-2008—《Non-active surgical implants-particular requirements for cardiac and vascular implants-specific requirements for arterial stents》

介绍了YY/T0663-2008标准的适用范围和基本内容,阐述了对标准部分条款的理解和测试中应注意的问题以及操作过程中应遵循的相关标准。它对于生产该类产品的厂商具有实际的指导意义,能促进产品质量的提高。

The article introduces the scope and guideline about the standard of YY/T 0663-2008. It shows the understandings of some items, the questions paid attention to during the practical testing and some related standards complied in the process of operation. Furthermore, it has instructing meaning for the users and improves the quality of stents.