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IEC 60601-2-91-ed.1.0
Medical electrical equipment - Part 2-91: Particular requirements for basic safety and essential performance of non-thermal plasma wound treatment equipment
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STANDARD published on 19.6.2026
The information about the standard:
Designation standards: IEC 60601-2-91-ed.1.0
Publication date standards: 19.6.2026
SKU: NS-1275505
The number of pages: 26
Approximate weight : 78 g (0.17 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 60601-2-91-ed.1.0 :
IEC 60601-2-91:2026 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). LIEC 60601-2-91:2026 sapplique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE TRAITEMENT DES PLAIES PAR PLASMA NON THERMIQUE et des ACCESSOIRES DE TRAITEMENT DES PLAIES PAR PLASMA NON THERMIQUE. Les APPAREILS DE TRAITEMENT DES PLAIES PAR PLASMA NON THERMIQUE et les ACCESSOIRES DE TRAITEMENT DES PLAIES PAR PLASMA NON THERMIQUE ne sont pas destines a fournir de la chaleur au PATIENT. Ils sont utilises pour traiter les plaies aigues et chroniques, ainsi que les tissus biologiques, mais aussi differentes maladies de la peau et demangeaisons. Les DANGERS inherents a la fonction physiologique prevue des appareils de traitement des plaies par plasma et des ACCESSOIRES DE TRAITEMENT DES PLAIES PAR PLASMA NON THERMIQUE compris dans le domaine dapplication du present document sont couverts par des exigences specifiques dans le 7.2.13 de lIEC 60601-1:2005, lIEC 60601-1:2005/AMD1:2012 et lIEC 60601-1:2005/AMD2:2020. Le present document ne sapplique pas aux APPAREILS EM destines a lhemostase des tissus biologiques (voir lIEC 60601-2-2 et lIEC 60601-2-76).
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