Are masks a medical device? Which types of medical devices are they?

Author:首康医疗 Time:2021-12-17 10:12:33 Hits:

Medical masks are mostly made of one or more layers of non-woven fabrics. The main production processes include meltblown, spunbond, hot wind or needle punch, etc., which have the equivalent effect of resisting liquids, filtering particles and bacteria, are a kind of medical protection. textile. It can filter particles in the air and block droplets, blood, body fluids, secretions, etc. It is a disposable product.

As the COVID-19 is still rampant, the whole China and the world are required to wear masks when going out. After all, medical masks are still fast and convenient way to isolate the virus. So that, medical masks now have become essential medical devices for families. Someone may ask, are masks a medical device? The answer is yes. It is not just the large-scale medical equipment used in hospitals that belong to medical equipment. Masks, non-woven fabrics, and medical absorbent cotton are all medical equipment, but the categories are different, so medical masks belong to several types of medical equipment. ? Under this type of medical device category, what qualifications are required to sell medical masks? Today we will talk in detail:

Medical equipment in my country is divided into three categories according to the risk of operation and the degree of harm to the human body. Medical masks are divided into three categories, because their operation requires a certain degree of professionalism to fully achieve the effect, and the harm to the human body is not It's not too big, so disposable medical masks are listed as a second-class medical device.

In my country, under the category of first-class medical devices, there are some conventional medical devices and medical dressings, such as non-woven fabrics, medical absorbent cotton, etc., which are commonly used in the manufacture of masks. These all belong to the catalog of first-class medical devices. There are scalpel handles, stethoscopes, dental knives, film holders, etc., all of which are first-class medical devices.

In the category of the second category of medical devices, the function and operation difficulty of medical device products will gradually increase. For example, our common blood glucose meters, blood pressure monitors, and other orthopedic consumables, etc., all belong to the category of the second category of medical devices.

Among the three types of medical equipment, there are many large-scale medical equipment, including CT, nuclear magnetic, ECMO and other familiar equipment, and some similar to TOMO knife, medical ultrasonic treatment equipment and other medical equipment that we are not familiar with. There are also many foreign cutting-edge technologies that have gradually entered the major hospitals in our country in recent years, providing a wealth of treatment methods for the treatment of patients in our country.

The development of modern medicine is increasingly inseparable from medical equipment. Under the category of medical equipment, disposable medical masks are also divided into two types of medical equipment. As my countrys medical equipment industry continues to expand and deepen, I believe there will be More and more medical devices come into our field of vision to provide the necessary guarantee for our life safety.


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