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The meaning of medical device implementation standards

Update:11-01-2022
Summary:

GB begins with national standards, which are divided in […]

GB begins with national standards, which are divided into mandatory national standards and recommended national standards.

The beginning of YY is the pharmaceutical industry standard, such as YY 0469-2011 "Technical Requirements for Medical Surgical Masks".

YZB is a registered product standard for medical devices.

There are two types of KN95/N95 masks, one is an anti-biological mask and the other is a dust mask.

They have the same degree of protection, but different implementation standards. The standard implemented by anti-biological masks (medical KN95) is GB19083-2010 "Technical Requirements for Medical Protective Masks", which are used in the medical and health industry, such as epidemic prevention stations, hospitals, disease control centers, etc. The standard implemented by dust masks (KN95) is GB2626-2006 "Respiratory Protective Equipment Self-Priming Filtering Anti-Particulate Respirator", which is used in industries such as coal mining, petroleum processing, mining and other industrial and mining enterprises.

If it is used by individuals in an ordinary environment, the standard that can be used is the KN95 (N95 if it is the American standard) mask of GB2626-2006. If it is a medical institution or contact with infected people, it is necessary to prevent the splash caused by the patient's body fluid or blood splash. In case of droplet infection, KN95 masks that implement the GB19083-2010 standard must be used.

To sum up, in a relatively high-risk environment, the masks that can effectively prevent respiratory infectious diseases are medical protective masks and medical surgical masks. Medical protective masks, also known as medical KN95, are suitable for use in fever clinics, medical staff in isolation wards, and transfer of confirmed patients. Medical surgical masks are suitable for suspected cases to be worn by public transport drivers, taxis, drivers, sanitation workers, and service personnel in public places when they are on duty.

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