Onda - Regulatory Measurements Services

• IEC 60601-2-5 Ed. 3.0. Medical Electrical Equipment – Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment. 2009.
• IEC 60601-2-36 Ed. 1.0. Medical Electrical Equipment – Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy. 1997.
• IEC 60601-2-37 Ed. 2.0. Medical Electrical Equipment – Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. 2007.
• IEC 60601-2-62: Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

We also carry out measurements to the following standards
IEC 62555: Ultrasonics – Power measurement – High intensity therapeutic ultrasound (HITU) transducers and systems, IEC/TS 62556: Ultrasonics – Field characterization – Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems, IEC 61846 Ed. 1.0. Ultrasonics – Pressure pulse lithotripters – Characteristics of fields. 1998, IEC 62359 Ultrasonics Ed. 2.0. Field characterization – Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields. 2010, IEC 61689 Ed. 2.0 Ultrasonics – Physiotherapy systems – Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz. 2007, IEC 61847 Ed. 1.0 Ultrasonics – Surgical Systems – Measurement and declaration of the basic output characteristics. 1998.