Near infrared functional brain imaging device, near infrared spectral functional brain imaging system, quantitative brain function imaging device (HS code(s): 901820; 902750; 903149); (ICS code(s): 11.040.55)

National Standard of the P.R.C., Medical electrical equipment –Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment; (32 page(s), in Chinese)

This document 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 adjunctive diagnostic purposes.

Not included within the scope of this particular standard are:

a) the equipment, as a part of ME equipment, measures oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules);

b) near-infrared spectroscopy (NIRS) tissue oximeter equipment, which is not intended for obtaining functional NIRS equipment output;

c) pulse oximeter equipment, which is not intended for obtaining functional NIRS equipment output. The requirements for pulse oximeter equipment are found in YY 9706.261.

d) frequency-domain and time-domain equipment for functional near-infrared spectroscopy may be subject to different test procedures than those defined herein.

e) functional near-infrared spectroscopy equipment, which measure changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin may be subject to different test procedures than those defined herein.