Category 1: usually refers to medical equipment that can guarantee its safety level and rationality through routine management;
The second category: usually refers to the medical equipment whose safety level, rationality or should be controlled; a. ECG diagnostic equipment: single-lead electrocardiograph, multi-lead electrocardiograph, fetal electrocardiograph, vector electrocardiograph, etc.; b. EEG diagnostic equipment: EEG machine, brain resistance meter, brain wave analyzer, EEG real-time analysis recorder, etc.; c. Non-invasive monitoring equipment: patient monitor, anesthetic gas monitor, respiratory function monitor, etc.
The third category: usually refers to the implanted human body, which is suitable for supporting and maintaining the value of life for a long time. It is uncertain and dangerous to the human body, and its safety level and rationality must be strictly controlled. Safety devices for first aid and treatment of the heart: such as cardiac pacemakers, cardiac defibrillation pacemakers, etc. b. Invasive electrophysiological instruments: such as patient invasive monitoring systems, intracranial pressure monitoring, etc. c. High frequency surgery And electrocoagulation mechanical equipment: such as high-frequency electric knife, high-frequency tonsil surgery device, radio frequency temperature control thermocoagulator, etc.
