Patient monitor, brain and regional tissue oxygen saturation sensor, brain and regional tissue oxygen saturation monitor, brain and regional blood oxygen detector, brain and regional blood oxygen sensor, non-invasive cerebral oxygen monitoring device (HS code(s): 901819); (ICS code(s): 11.040.10)

National Standard of the P.R.C., Medical electrical equipment — Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment; (68 page(s), in Chinese)

This document applies to basic safety and essential performance requirements of cerebral tissue oximeter equipment.

This document applies to cerebral tissue oximeter equipment for human application, including cerebral tissue oximeter monitors, cerebral tissue oximeter probes and probe cable extenders. This document also applies to medical electrical (ME) cerebral tissue oximeter equipment intended to compensate or alleviate diseases and injuries, as well as such equipment intended for home care and emergency medical service environments, such as ambulances and air medical transport. Supplementary standards may be applicable to such equipment used in these environments.