The second class of medical devices refers to its safety, effectiveness should be controlled medical devices. Mainly includes thermometers, sphygmomanometers, hearing aids, oxygen concentrators, condoms, acupuncture needles, dental comprehensive treatment instrument, medical cotton wool, medical cotton wool, medical gauze, automatic biochemical analyzers, incubators and other medical devices.
In the specific provisions indicate that any in vitro application without direct contact with the skin or tissues, relatively simple structure, relatively single function, no external or built-in power supply or other power source, a certain degree of assistance or relief of symptoms or preventive effect, and there is a potential risk of very little or virtually no risk, without the need for special management can be ensured that the medical device is a Class I medical device.
Disposable masks must not be used interchangeably when in use. The outer layer of the mask tends to accumulate a lot of dust, bacteria and other dirt in the outside air, while the inner layer blocks the exhaled bacteria, saliva, alternate use will be the outer layer of pollutants will be inhaled into the human body in the face of the tightly as a source of infection.