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
Abstract
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.
Begin
2023-08-18
Planned document number
DIN EN IEC 80601-2-71
Project number
02231794
Responsible national committee
DKE/GUK 812.1 - Diagnostik und Brain Computer Interfaces
draft standard
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
2024-08
Order from DIN Media
