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E DIN EN IEC 80601-2-71 VDE 0750-2-71:2024-08

Medical electrical equipment

Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment

(IEC 62D/2062/CDV:2023); German and English version prEN IEC 80601-2-71:2023
Class/Status: Draft, valid
Released: 2024 -08   Published: 2024-07 -12
VDE Art. No.: 1701956
End of objection deadline: 2024-09-12

This document applies to the Basic Safety and Essential Performance of Functional NIRS Equipment, as defined in 201.3.205, intended to be used by itself, or as a part of an ME System hereinafter referred to as ME Equipment. The document has been prepared to address the relevant essential principles and labelling guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex DD.