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
Opšte informacije
Status:Projekt
Broj stranica:22
Metoda usvajanja:Proglašavanje
Jezik:engleski
Izdanje:3.
Datum realizacije:28.11.2025
Predviđeni datum naredne faze:20.02.2026
Tehnički komitet:BAS/TC 25, Zaštita zdravlja
ICS:
11.040.55, Dijagnostička oprema
11.040.20, Transfuzijska, infuzijska i injekcijska oprema
11.040.99, Ostala medicinska 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.
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EN IEC 60601-2-40:2025, identičan
IEC 60601-2-40:2024, identičan
Veza sa BAS standardima
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