Comitato Elettrotecnico Italiano

Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
 N EN 60601-2-62

Annotation

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT as defined in 201.3.218, hereafter referred to as ME EQUIPMENT.

This International Standard adds or replaces clauses listed in the IEC 60601-1 that are specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE 1 See also 4.2 of the general standard.

NOTE 2 As, in HITU fields, the acoustic waveform is expected to be extremely distorted due to non-linear propagation effects, the ultrasonic measurements are to be made under quasi linear conditions and then extrapolated following procedures given in IEC/TS 62556. See also IEC/TS 61949

This standard can also be applied to:

– therapeutic equipment for thrombolysis through exposure to high-intensity therapeutic ultrasound;

– therapeutic equipment for the treatment of occluding feeding vessels through exposure to high-intensity focused ultrasound;