Safety & Compliance Forum

201.1 Scope, object and related standards
Clause 1 of the general standard 1) applies, except as follows:
201.1.1 Scope
Addition:
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;
– equipment intended to be used for relieving cancer pain due to bone metastases.
This particular standard does not apply to:
• ULTRASOUND EQUIPMENT intended to be used for physiotherapy (use: IEC 60601-2-5 [1] 2) and IEC 61689);
• ULTRASOUND EQUIPMENT intended to be used for lithotripsy (use: IEC 60601-2-36 [ 2]);
• ULTRASOUND EQUIPMENT intended to be used for dedicated hyperthermia devices;
• ULTRASOUND EQUIPMENT intended to be used for phacoemulsification.

Standard identically adopts IEC 60601‐2‐62:2013 which specifies safety requirements additional to those in IEC 60601‐1 for high intensity therapeutic ultrasound equipment. It adds or replaces clauses listed in IEC 60601‐1 that are specific for high intensity therapeutic ultrasound equipment. Applies to the basic safety and essential performance of high intensity therapeutic ultrasound equipment.