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dnaSRPS EN IEC 60601-2-40:2024

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

General information

50.60     Oct 18, 2024

ISS

N062

European Norm

11.040.20     11.040.55     11.040.99  

English  

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

PUBLISHED
SRPS EN 60601-2-40:2019

NOW

PROJECT
dnaSRPS EN IEC 60601-2-40:2024
50.60 Close of voting. Proof returned by secretariat
Oct 18, 2024

Related project

Adopted from EN IEC 60601-2-40:2025

Adopted from IEC 60601-2-40:2024 ED3 IDENTICAL