scope:

This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT intended 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. Not included within the scope of this particular standard are: a) the part of ME EQUIPMENT if provided, that measures oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules); b) NIRS tissue oximeter equipment, which are not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output. c) PULSE OXIMETER EQUIPMENT, which are not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output. The requirements for PULSE OXIMETER EQUIPMENT are found in ISO 80601-2-61. NOTE For example, other ME EQUIPMENT that produce FUNCTIONAL NIRS EQUIPMENT output for adjunctive 40 diagnostic purposes, e.g. PATIENT monitors;