DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
Abstract
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 standard can also be considered for: – equipment for blood brain barrier opening through exposure to therapeutic Ultrasound; – equipment for neuro nerve modulation through exposure to therapeutic Ultrasound; – equipment for aesthetic and cosmetic applications through exposure to therapeutic Ultrasound. This particular standard does not apply to: - Ultrasound Equipment intended to be used for physiotherapy (use: IEC 60601-2-5 [1] 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 surgical/cutting procedures (IEC 61847).
Begin
2026-06-18
Planned document number
DIN EN IEC 60601-2-62
Project number
02233962
