IEC 60601-2-40:2024 ED3

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

Publication date:   Dec 20, 2024

General information

60.60   Standard published   Dec 20, 2024

IEC

TC 62/SC 62D

International Standard

11.040.20   Transfusion, infusion and injection equipment | 11.040.55   Diagnostic equipment | 11.040.99   Other medical equipment

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
IEC 60601-2-40:2016 ED2

NOW

PUBLISHED
IEC 60601-2-40:2024 ED3
60.60 Standard published
Dec 20, 2024