This standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, marking, packaging, transportation and storage of high-intensity focused ultrasound (HIFU) treatment systems. This standard applies to externally focused high-intensity focused ultrasound (HIFU) treatment systems (hereinafter referred to as HIFU treatment systems). The system is used for extracorporeal high-intensity focused ultrasound ablation treatment.
YY 0592-2016 Referenced Document
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB/T 14710 Enviromental requirement and test methods for medical electrical equipment
GB/T 191 Packaging.Pictorial marking for handling of goods
GB/T 19890-2005 Acoustics-High intensity focused ultrasound(HIFU)measurements of acoustic power and field characteristics