NBN 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

ACTIVE

About this standard

Languages
English and French
Type
NBN Electro
Status
ACTIVE
Publication date
15 February 2025
ICS Code
11.040.20 (Transfusion, infusion and injection equipment)
11.040.55 (Diagnostic equipment)
11.040.99 (Other medical equipment)
Withdrawn Date
Price
€ 212,00

About this training

Summary

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.