摘要
心脏射频消融治疗设备是一种用于心脏介入消融手术的医用高频设备。该设备的行业标准YY0860-2011《心脏射频消融治疗设备》已于2013年6月1日起正式实施,该标准规范了产品的性能参数及安全特征。本文主要对YY0860-2011标准的适用范围、主要性能要求及试验方法进行分析探讨。
Radio frequency ablation instrument is a medical high frequency equipment, which is always used in interventional cardiac ablation. YY0860-2011 Radio frequency ablation instrument for cardiac application has been implemented from Jun lst 2013. The standard contains requirements for performance and safety. This paper analyzes the scope of application, essential requirements and test methods ofYY0860-2011.
出处
《中国医疗器械信息》
2016年第10期57-60,70,共5页
China Medical Device Information
关键词
心脏射频消融
行业标准
性能要求
cardiac radiofrequency ablation, industry standard, requirements for performance
