1, the concept of different: Class I medical device refers to a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices, Class II medical device refers to the risk of moderate, need to strictly control the management in order to ensure its safety and effectiveness of medical devices.
2, including different devices: a class of medical devices include: thermometers, sphygmomanometers, electrocardiographs, X-ray machines, ordinary optical microscopes, medical X-ray devices, biochemical analyzers, medical imaging equipment (X-ray equipment). Class II medical devices mainly include: household ultrasound instruments and equipment (ultrasound instrument, etc.), medical laser instruments and equipment, surgical instruments, medical supplies (sewing machines, etc.), household medical instruments and supplies (such as blood glucose meter, etc.).
3, the degree of risk is different: the first class of medical devices low risk, the use of routine management can ensure its safety and effective medical devices, the second class of medical devices is medium risk, the use of strict control of the management means to ensure its safety and effective medical devices.