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IEC 60601-2-40 Pre-release version

IEC 60601-2-40:2024 PRV
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
This Final Draft International Standard is an up to 6 weeks' pre-release of the official publication. It is available for sale during its voting period: 2024-09-06 to 2024-10-18. By purchasing this FDIS now, you will automatically receive, in addition, the Redline version of the final publication.

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.
PRE-RELEASE VERSION
English
Electronic

Technical committee

TC 62/SC 62D Particular medical equipment, software, and systems

Category

Safety
Publication typeInternational Standard
Publication date2024-09-06
Edition3.0
ICS

11.040.20

11.040.55

11.040.99

Stability date2029
Pages30
File size986.21 KB
EditionDatePublicationEditionStatus

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