Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC PHYSIOTHERAPY EQUIPMENT as defined in 201.3.216, hereafter referred to as ME EQUIPMENT.

This Standard only relates to ULTRASONIC PHYSIOTHERAPY EQUIPMENT employing a single plane unfocused circular transducer per TREATMENT HEAD, producing static beams perpendicular to the face of the TREATMENT HEAD.

This Standard can also be applied to ULTRASONIC PHYSIOTHERAPY EQUIPMENT used for compensation or alleviation of disease, injury or disability.

In the case of combined EQUIPMENT (e.g. EQUIPMENT additionally provided with a function or an APPLIED PART for electrical stimulation) such EQUIPMENT shall also comply with any particular standard specifying safety requirements for the additional function.

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.

This particular standard does not apply to:
 

• EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry);
• EQUIPMENT in which focused ULTRASOUND pulse waves are used to destroy conglomerates such as stones in the kidneys or the bladder (lithotripters) (for information refer to IEC 60601-2-36);
• ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ultrasound pulse waves are used.