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E DIN EN IEC 60601-2-91 VDE 0750-2-91:2025-05

Medical electrical equipment

Part 2-91: Particular requirement for basic safety and essential performance of non-thermal plasma wound treatment equipment

(IEC 62D/2183/CDV:2024); German and English version prEN IEC 60601-2-91:2024
Class/Status: Draft, valid
Released: 2025 -05   Published: 2025-04 -11
VDE Art. No.: 1701973
End of objection deadline: 2025-06-11

This part of IEC 60601 applies to the basic safety and essential performance of non-thermal plasma wound treatment equipment hereafter referred to as ME-equipment. Non-thermal plasma wound treatment equipment apples to chronic and acute wounds as well as diverse skin and itching diseases. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 of the general standard.