Medical device, refers to a single or a combination of instruments, equipment, apparatus, materials or other items used in the human body, including the required software; its use in the human body and the body's role is not to use pharmacology, immunology or metabolism of the means to obtain, but there may be these means to participate in and play a certain auxiliary role in the disease for the treatment of the means of the apparatus.
In the country for the oxygen concentrator is a medical device is a clear standard:
1. when in the 3L/min oxygen output, the concentration of oxygen must be maintained at more than 90%
2. to have a medical device registration certificate
3. must be able to sustain the production of oxygen and ensure that no less than 48 hours of continuous operation.
As long as the oxygen concentrator meets the above conditions, it can be said that it belongs to the medical device, less a condition can only be categorized as a health care oxygen concentrator, we should pay attention to the difference in the purchase, do not listen to too much to the merchant's boasting.