Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

This document establishes the specialized safety and essential performance requirements for high-intensity ultrasound therapy equipment used in medical settings. It serves as a harmonized European standard adopted at the national level, providing detailed technical specifications to ensure the safe operation of devices that utilize high-intensity ultrasound waves for therapeutic purposes. The scope covers essential aspects such as general requirements specific to this equipment type, performance testing criteria, and risk mitigation measures designed to protect patients, users, and operators during clinical application. It aligns with the corresponding international standard developed by the International Electrotechnical Commission, ensuring consistency in safety expectations across different markets. The content focuses on the design, construction, and performance characteristics unique to high-intensity ultrasound systems, addressing potential hazards associated with the acoustic output and thermal effects generated during treatment procedures.