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DIN EN IEC 80601-2-71 VDE 0750-2-71:2026-03

Medical electrical equipment

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

(IEC 80601-2-71:2025); German version EN IEC 80601-2-71:2025
Class/Status: Standard, valid
Released: 2026-03
VDE Art. No.: 0701658

Note: You can pre-order this document (delivery subject to availability). Valid from 2026-03-01.

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.