摘要
本文介绍了国内外超声设备准入法规对超声诊断设备在临床应用过程中产生的生物学效应、探头表面温度升高等相关参数指标所进行的限制,以及产品在设计时如何对这些参数进行测量、计算和仿真的过程。
This paper describes regulatory restrictions for marketing ultrasound diagnostic systems at home and abroad in terms of bioeffects and relevant parameters such as probe surface temperature rise in clinical application, as well as how to measure, calculate and simulate such parameters in product design.
出处
《中国医疗器械信息》
2014年第7期8-12,共5页
China Medical Device Information
关键词
医用超声
安全性设计
生物学效应
medical ultrasound
safety design
biological effects
