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.