prBAS EN IEC 60601-2-40:2026
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
General information
Status:Project
Number of pages:22
Adoption method:Proglašavanje
Language:engleski
Edition:3.
Realization date:28.11.2025
Forseen date for next stage code:20.02.2026
Technical committee:BAS/TC 25, Healthcare
ICS:
11.040.55, Diagnostic equipment
11.040.20, Transfusion, infusion and injection equipment
11.040.99, Other medical equipment
11.040.20, Transfusion, infusion and injection equipment
11.040.99, Other medical equipment
Abstract
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.
Lifecycle
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Original document and degree of correspondence
EN IEC 60601-2-40:2025, identical
IEC 60601-2-40:2024, identical
Relation to BAS standards
Work material
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