prEN IEC 60601-2-36:2026

This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of therapy equipment for EXTRACORPOREALLY INDUCED FOCUSED PRESSURE PULSES as defined in 201.3.212, hereafter referred to as ME EQUIPMENT. The applicability of this particular standard is limited to components directly involved in the PRESSURE PULSE treatment, such as, but not limited to, the generator of the PRESSURE PULSE, and their interactions with other devices, such as e.g. patient support, imaging, monitoring or treatment planning devices. Such devices themselves are excluded from this standard, because they are treated in other applicable IEC standards.
This particular standard does not apply to:
– ULTRASOUND PHYSIOTHERAPY EQUIPMENT intended to be used for physiotherapy;
– ULTRASOUND equipment intended to be used for high intensity therapeutic ULTRASOUND (HITU) and other therapy equipment as described in Annex AA;
Note:
IEC 60601-2-5 is the particular standard for ULTRASOUND PHYSIOTHERAPY EQUIPMENT and IEC 60601-2-62 is the particular standard for HITU equipment.