IEC 60601-2-5 Medical Electrical Equipment - Special Requirements for Basic Safety and Basic Performance of Ultrasonic Physiotherapy Equipment

IEC 60601-2-5 applies to the basic safety and basic performance of ultrasonic physiotherapy equipment, which uses a single plane unfocused circular transducer per treatment head, generating static beams perpendicular to the face of the treatment head. This standard is also applicable to ultrasonic physiotherapy equipment used for the compensation or alleviation of disease, injury or disability. This edition constitutes a technical revision. Numbering has been revised to comply with IEC 60601-1 (third edition).

In the case of combined equipment (for example, equipment provided with an additional function or part applied for electrical stimulation), that equipment must also comply with any specific standard that specifies safety requirements for the additional function. If an article or subclause is specifically intended to apply to ME equipment only or ME systems only, the title and content of that article or subclause shall indicate so. If this is not the case, the item or subclause applies to both ME equipment and related ME systems.

This particular standard does not apply to:

• Equipment in which an instrument is powered by ultrasound (for example, equipment used in surgery or dentistry);
• Equipment that uses focused ultrasound pulse waves to destroy clumps such as stones (lithotriths) in the kidneys or bladder;
• Ultrasonic physiotherapy device using focused ultrasound pulse waves.

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