EN IEC 60601-2-40:2025

Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment EN IEC 60601-2-40:2025

Publication date:   Sep 6, 2024

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.