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IEC 60601-2-5 Ultrasonic Physiotherapy Equipment Testing

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

IEC 60601-2-5 Scope:

IEC 60601 2 5 and EN 60601 2 5 testing applies to the basic safety and essential performance of ultrasonic physiotherapy equipment as defined in 201.3.216, hereafter referred to as medical electronic equipment.

IEC 60601-2-5 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.

EN 60601-2-5 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 sub-clause is specifically intended to be applicable to medical electronic equipment only, or to medical equipment systems only, the title and content of that clause or sub-clause will say so. If that is not the case, the clause or sub-clause applies both to medical electronic equipment and to medical equipment systems, as relevant.

Hazards inherent in the intended physiological function of medical electronic equipment or medical equipment 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.

IEC-60601-2-5 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.

Keystone Compliance assists manufacturers with IEC 60601-2-5 and EN 60601-2-5 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-5 test lab needs.