Mask classification and common mask modelsMask classification and common mask models
Due to the impact of the pneumonia epidemic, medical masks have become one of the medical devices that people are more concerned about. Recently, there have been many issues related to the registration of mask-related products, medical device registration, medical device business license, and second-class medical device business records. This article introduces you to the relevant knowledge of masks.
Introduction: Due to the impact of the pneumonia epidemic, medical masks have become one of the medical devices that people are more concerned about. Recently, there have been many consultations on the registration of mask-related products, medical device registration, medical device operation permits, and second-class medical device operation records. Write an article to introduce you to the relevant knowledge of masks.
Respirator is a kind of sanitary product, generally refers to a device that is worn on the nose and mouth to filter the air entering the nose and mouth in order to block harmful gases, odors, and droplets from entering and exiting the wearer's mouth and nose. Masks have a certain filtering effect on the air entering the lungs. When respiratory infectious diseases are prevalent and when working in a polluted environment such as dust, wearing a mask has a very good effect.
1. Classification of masks and related standards
According to different applicable standards, masks can be divided into three categories: medical masks, self-priming filter anti-particulate respirator, and ordinary degreased gauze masks.
(1) Medical mask
Medical masks are divided into medical protective masks, medical surgical masks, and ordinary medical masks (disposable medical masks).
1. Medical protective masks comply with the relevant requirements of the national mandatory standard GB19083-2010 "Technical Requirements for Medical Protective Masks". It is suitable for self-priming and filtering medical protective masks that filter particulates in the air and block droplets, blood, body fluids, secretions, etc. in the medical environment. Medical protective masks according to GB19083 use "level 1" "level 2" and "level 3" to represent the filtration efficiency level. GB19083 also put forward the requirements of "synthetic blood penetration" and "surface moisture resistance" parameters, and clarified the protective effect of medical protective masks on blood, body fluids and other liquids. Generally, the filtration efficiency of N95 / KN95 can be achieved at level 1.
In addition, the N95 masks that everyone is currently concerned with are in compliance with the NIOSH42 CFR84-1995 standard requirements of the National Institute of Occupational Safety (NIOSH), including N95, N99, N100, R series, and P series. N95 masks that meet medical standards can be used for protection in medical institutions. There are more than 10 types of masks produced by 3M that meet the N95 standard, but only 1860 (1860S for children) and 9132 are medical protective masks, and 2042F and 2042FP models can be used as medical surgical masks.
2. Medical surgical masks comply with the relevant requirements of the medical industry standard YY0469-2011 "Technical Requirements for Medical Surgical Masks", and are suitable for disposable masks worn by clinical medical personnel during invasive operations. It is used to cover the mouth, nose and jaw of the user, and provides physical protection to prevent the direct transmission of pathogenic microorganisms, body fluids, and particles. This type of mask generally has a filtration efficiency of more than 30% for non-oily particles and a filtration efficiency of more than 95% for bacteria. In addition, for the permeability of synthetic blood, the mask is generally divided into three layers: internal water absorption Layer, middle filter layer, outer waterproof layer, each layer has a special role.
3. Ordinary medical masks, comply with the relevant registered product standards (YZB) or the pharmaceutical industry recommended standards YY / T 0969-2013 "disposable medical masks" relevant requirements, suitable for covering the mouth, nose and jaw of the user, used for Disposable masks that are worn in ordinary medical environments to block the exhalation or spraying of pollutants from the mouth and nasal cavity, generally cannot guarantee the filterability of pathogenic microorganisms and dust. Daily cross infection.
(2) Self-priming filter type anti-particulate respirator
1. KN mask, KP mask. It complies with the relevant requirements of the national compulsory standard GB2626-2006 "Respiratory protective equipment self-priming filter anti-particulate respirator". It is suitable for self-priming filter protective products for the protection of various types of particulate matter. It is not suitable for the protection of harmful gases and vapors. Respiratory protective equipment for anoxic environments, underwater operations, escape and firefighting. Among them, KP masks are mainly used in the chemical industry, not for civilian use. KN masks are classified into KN90, KN95, and KN100 according to their filtering performance for non-oily particulate matter. Among them, KN95 masks have a filtration performance of more than 95% for non-oily particulates, but KN masks and KP masks cannot be used for protection in medical institutions because they do not require penetration resistance.
2. Korean KF94 mask. This type of mask is a standard established by Korean production. The mask under this standard has a filtration rate of more than 94% for particles with a diameter of 0.4 μm. Therefore, KF94 masks are similar to KN95. KF94 masks are not for medical standards and cannot be used for medical institution protection.
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