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>BSI Standards >11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.20 Transfusion, infusion and injection equipment>BS EN IEC 60601-2-40:2025 - TC Tracked Changes. Medical electrical equipment Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
immediate downloadReleased: 2025-03-03
BS EN IEC 60601-2-40:2025 - TC Tracked Changes. Medical electrical equipment Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

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

Tracked Changes. Medical electrical equipment Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

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Standard number:BS EN IEC 60601-2-40:2025 - TC
Pages:86
Released:2025-03-03
ISBN:978 0 539 36052 3
Status:Tracked Changes
DESCRIPTION

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.
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