BS EN IEC 60601-2-40:2025 - TC

This standard BS EN IEC 60601-2-40:2025 - TC Tracked Changes. Medical electrical equipment is classified in these ICS categories:

• 11.040.55 Diagnostic equipment
• 11.040.99 Other medical equipment
• 11.040.20 Transfusion, infusion and injection 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.