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IEC 60601-2-40-ed.3.0
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Translate name
STANDARD published on 20.12.2024
The information about the standard:
Designation standards: IEC 60601-2-40-ed.3.0
Publication date standards: 20.12.2024
SKU: NS-1209119
Approximate weight : 300 g (0.66 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Transfusion, infusion and injection equipmentDiagnostic equipmentOther medical equipment
Annotation of standard text IEC 60601-2-40-ed.3.0 :
IEC 60601-2-40:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT. The following ME EQUIPMENT are excluded: - ME EQUIPMENT intended for therapeutic application; - ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10). IEC 60601-2-40:2024 cancels and replaces the second edition published in 2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) added requirements for constant voltage stimulators; b) clarified requirements for VISUAL STIMULATORS. LIEC 60601-2-40:2024 sapplique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ELECTROMYOGRAPHES et des APPAREILS A POTENTIEL EVOQUE, designes ci-apres sous le terme APPAREILS EM. Les APPAREILS EM suivants sont exclus de la liste: - APPAREILS EM destines a une application therapeutique; - APPAREILS EM destines a etre utilises avec les neurostimulateurs electriques transcutanes et les stimulateurs musculaires electriques (APPAREILS EM couverts par lIEC 60601-2-10). LIEC 60601-2-40:2024 annule et remplace la deuxieme edition parue en 2016. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: a) des exigences relatives aux stimulateurs a tension constante ont ete ajoutees; b) des exigences relatives aux STIMULATEURS VISUELS ont ete clarifiees.
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