From the characteristics of the three to determine:
1, a class of medical devices is a low degree of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices.
2, Class II medical device is a medium risk, need to strictly control the management to ensure its safety and effectiveness of medical devices. Including X-ray film machine, ultrasound, microscope, biochemistry, etc. are classified as Class II medical devices.
3, Class III medical device is a higher risk, need to take special measures to strictly control the management to ensure its safety, effective medical devices. Refers to implanted in the human body, used to support, life-sustaining, potentially dangerous to the human body medical devices.
Expanded Information:
Common medical equipment:
1, home medical rehabilitation equipment (a class): home cervical and lumbar traction device, traction chair, physical therapy instruments, sleep instrument, massage instrument, functional chair, functional beds, support, medical inflatable air mattress; Oxygen concentrator, decoctors, hearing aids and so on.
2, commonly used medical equipment in hospitals (Class II): trauma disposal vehicles, surgical beds, surgical lights, monitors, anesthesia machines, respiratory machines, blood cell analyzers, differentiation analyzers, enzyme markers, plate washer, urine analyzers, ultrasound (ultrasound, ultrasound, etc.), X-ray machines, nuclear magnetic *** vibration and so on.
3, medical electronic instruments and equipment (Class III), medical optical instruments, instruments and endoscopic equipment, medical magnetic **** vibration equipment, medical X-ray equipment, operating room, emergency room, diagnostic and treatment room equipment and apparatus.
Baidu Encyclopedia - Medical Devices
Baidu Encyclopedia - Class I Medical Devices
Baidu Encyclopedia - Class II Medical Devices
Baidu Encyclopedia - Class III Medical Devices