UNE EN IEC 60601-2-91:2026
Medical electrical equipment - Part 2-91: Particular requirements for basic safety and essential performance of non-thermal plasma wound treatment equipment (Endorsed by Asociación Española de Normalización in September of 2026.)
Equipos electromédicos. Parte 2-91: Requisitos particulares para la seguridad básica y funcionamiento esencial del equipo de tratamiento de heridas con plasma no térmico. (Ratificada por la Asociación Española de Normalización en septiembre de 2026.)
| Standard number: | UNE EN IEC 60601-2-91:2026 |
| Released: | 2026-09-01 |
| Status: | Standard |
| Pages (English): | 29 |
UNE EN IEC 60601-2-91:2026
201.1 Scope, object and related standards Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 applies, except as follows: 201.1.1 Scope Replacement: 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 and IEC 60601-2-76). 201.1.2 Object Replacement: The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES, as defined in 201.3.204 and 201.3.203.