IEC 60601-2-91 Ed. 1.0 b:2026

Full Description

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL

PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT

ACCESSORIES.

NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND

TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat

chronic and acute wounds and biological tissue as well as diverse skin and itching diseases.

HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT

and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document

are covered by specific requirements in 7.2.13 of IEC 60601-1:2005,

IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.

This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue

(see IEC 60601-2-2[1]1 and IEC 60601-2-76[2]).