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) with an acoustic operating frequency range of 0.5MHz to 2.0MHz.
YY 0592-2005 Referenced Document
GB 10152-1997 B mode ultrasonic diagnostic equipment
GB 9706.1-1995 Medical electrical equipment--Part 1: General requirements for safety
GB 9706.15-1999 Medical electrical equipment Part 1: General requiements for safety 1.Collateral standard: Safety requirements for medical electrical systems
GB/T 191-2000 Packaging-Pictorial marking for handling of goods