IEC 60601-2-40:2024

IEC 60601-2-40:2024

December 2024
International standard Current

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

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.

Main informations

Collections

International IEC standards

Publication date

December 2024

Number of pages

62 p.

Reference

IEC 60601-2-40:2024
Sumary
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

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.
Replaced standards (1)
IEC 60601-2-40:2016
August 2016
International standard Cancelled
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

IEC 60601-2-40:2016 applies to the basic safety and essential performance of electromyographs and evoked response equipment, hereafter referred to as ME equipment. ME equipment intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators are excluded (covered by IEC 60601-2-10). This second edition cancels and replaces the first edition of IEC 60601-2-40 published in 1998. This edition constitutes a technical revision.

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