prBAS EN IEC 60601-2-40:2026

Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment


Opće informacije
Status:Projekt
Broj stranica:22
Metoda usvajanja:Proglašavanje
Jezik:engleski
Izdanje:3.
Nadnevak realizacije:28.11.2025
Predviđeni nadnevak naredne faze:20.02.2026
Tehnički komitet:BAS/TC 25, Zdravstvena skrb
ICS:
11.040.55, Dijagnostička oprema
11.040.20, Transfuzijska, infuzijska i injekcijska oprema
11.040.99, Ostala medicinska oprema

Apstrakt
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.

Životni ciklus
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Izvorni dokument i stepen usklađenosti
EN IEC 60601-2-40:2025, identičan
IEC 60601-2-40:2024, identičan

Veza sa BAS standardima

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