IEC 80601-2-71:2015(E) applies to the basic safety and essential performance of functional NIRS equipment intended to be used by themselves, or as a part of an ME system, for the production of functional NIRS equipment output for adjunctive diagnostic purposes, hereinafter referred to as ME equipment.
IEC 80601-2-71 Ed. 1.0 en:2015
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Medical electrical equipment – Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment