Standard No.:	YY 9706.262-2021
English Name:	Medical electrical equipment—Part 2-62:Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound(HITU) equipment
Chinese Name:	医用电气设备 第2-62部分：高强度超声治疗（HITU）设备的基本安全和基本性能专用要求
Chinese Classification:	C41    Medical ultrasound, laser, high-frequency instrument and equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.50 11.040.50    Radiographic equipment 11.040.50
Issued by:	National Medical Products Adminstration
Issued on:	2021-03-09
Implemented on:	2023-5-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	25000 words
Price(USD):	750.00
Delivery:	via email in 1~5 business day

本标准不适用本标准适用于高强度超声治疗设备的基本安全和基本性能。本标准增加或替换了GB 9706.1中针对高强度超声治疗设备的特定条款。
本标准也适用于暴露于高强度治疗超声下的溶栓治疗设备；暴露于高强度治疗超声下的闭塞滋养血管治疗设备；预期用于缓解因癌症转移致骨骼上导致疼痛的设备。
本标准不适用于：
用于理疗的超声设备；
用于碎石的超声设备；
用于热疗的超声设备；用于白内障乳化的超声设备。