Project
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
Abstract
This International standard 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
