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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.

This Document is related to the following Topics (in bold):

11	HEALTH CARE TECHNOLOGY
11.020	Medical sciences and health care facilities in general
11.040	Medical equipment
11.060	Dentistry
11.080	Sterilization and disinfection
11.100	Laboratory medicine
11.140	Hospital equipment
11.180	Aids for disabled or handicapped persons

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Title		Format
	Prinz, Thorsten (Hrsg.) Entwicklung und Herstellung medizinischer Software Normen in der Medizintechnik VDE-Schriftenreihe – Normen verständlich, Band 171 2017, 219 pages, Din A5, Broschur Dieser Buchtitel ist auch als E-Book (PDF) erhältlich