1. What is a medical device
What is a medical device? Broadly speaking, equipment, instruments, tools, consumables, even computers, calculators, etc. that directly or indirectly act on the human body or outside of the body, are separated from medical methods, pathology, and participate in the treatment process to achieve the purpose of treatment. , Can be counted as the category of medical devices. The scope of medical equipment is extremely wide. You may think that only large-scale medical equipment in hospitals, such as CT and nuclear magnetic machines, are medical equipment. You don’t know that masks and contact lenses are daily and almost everyone. All of them are also medical devices.
2. The main purpose of the medical device
2.1. Diagnosis of disease
2.2. Assistance in the process of disease treatment
2.3. Postoperative recovery and maintenance.
2.4. Maintain or support life.
2.5. Mitigation and monitoring of disease dynamics and disease control
2.6. Other content in the medical link.
3. Classification of medical devices
As mentioned earlier, masks can be medical devices, and so can CT. If they are grouped together, it will be very troublesome to manage and error-prone. Therefore, in order to avoid this problem, our country classifies medical devices according to the degree of risk. .
A type of medical device: This type of medical device has a low degree of risk, as long as it is used properly, the risk and the consequences are relatively small. Our common surgical scalpels, X-ray films, masks and other consumables, drainage bags, surgical gowns, gauze bandages, etc. All belong to the category of first-class medical devices
Type II medical devices: This type of medical devices are of a medium risk level and require careful and compliant operations to achieve normal use purposes. Representatives of this type of machinery are: sphygmomanometers, blood glucose meters, hearing aids, microscopes, B-ultrasound, X-ray film machines, constant temperature incubators, cupping devices, etc.
Three types of medical equipment: This type of medical equipment has a high degree of risk, requires careful operation, and requires professionals with sufficient knowledge reserves, and also has great requirements for maintenance and maintenance. There is a part that needs to act directly on the human body, which is of great significance for maintaining and supporting life. Once the operation is wrong, it will seriously endanger the life of the patient. For this type, my country needs strict supervision. Representatives of this type of equipment include: cardiac pacemakers, ultrasonic scalpels, laser surgery equipment, artificial heart-lung machines, CT, heart valves, nuclear magnetic machines, etc. It is worth mentioning that contact lenses also belong to the third category of medical devices. It can be seen that the risk of contact lenses is still very large, so when you wear them, you must go through the guidance of professionals and wear them safely.
The above is a sorting out of the basic knowledge points of medical devices, through which everyone can have a preliminary understanding of medical devices.
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