GB 12259-1990
Abolished
YY/T 0750-2026
Pending
Industry standards-Medicine
YY/T 0750-2026 Ultrasonics—Physiotherapy systems—Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
YY/T 0750-2026 Ultrasonics—Physiotherapy systems—Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
Basic Information
Standard Code:
YY/T 0750-2026
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical ultrasound, laser, and high-frequency instruments and equipment
ICS Name:
Treatment equipment
Publish Date:
2026-03-09
Implement Date:
2027-03-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用电器标准化技术委员会医用超声设备分技术委员会(SAC/TC 10/SC 2)
Pages:
52 pages
Scope
本文件规定了:
——基于基准试验方法的超声理疗设备输出的测量和表征方法;
——由超声理疗设备制造商依据基准试验方法规定的特性;
——超声理疗设备所产生超声声场的安全性导则;
——基于常规试验方法的超声理疗设备输出的测量和表征方法;
——基于常规试验方法的超声理疗设备输出的验收准则。
本文件适用于在0.5 MHz~5 MHz频率范围内,由超声换能器产生连续波或准连续波(如猝发音),设计用于理疗目的的超声设备。该超声理疗设备使用单一平面非聚焦圆形换能器作为治疗头,其产生的静态声束垂直于治疗头端面。
注1:本文件不包括超声理疗设备的治疗参数和使用方法。
注2:使用频率范围在20 kHz~500 kHz的超声理疗设备由IEC 63009规定。
Development Information
Drafting Units:
湖北省医疗器械质量监督检验研究院
Drafting Persons:
王志俭、吴成志、蒋时霖
Replace the following standards
Referenced Standards
GB/T 7966-1987 Acoustics—Ultrasonic power measurement in the frequency range 0.5~10MHz
GB/T 7966-2009 Acoustics—Ultrasonics power measurement—Radiation force balances and performance requirements
GB/T 7966-2022 Acoustics—Ultrasonic power measurement—Radiation force balances and the requirements
GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB 9706.205-2020 Medical electrical equipment—Part 2-5:Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
YY/T 0865.1-2011 Ultrasonic—Hydrophone—Part 1:Measurement and characterization of medical ultrasonic fields up to 40 MHz
YY/T 0865.1-2024 Ultrasonics—Hydrophones—Part 1:Measurement and characterization of medical ultrasonic fields
Adopt standards
IEC 61689:2022
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