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kn95 mask quality inspection standard

by:Copper Plus     2021-06-01
KN95 is a grade label from the Chinese standard 'GB Respiratory Protective Equipment-Self-priming Filtered Anti-Particulate Respirator'. This standard clarifies the scope of application of the mask-self-priming filtering respiratory protective equipment that protects all kinds of particulate matter. .  KN95 means that the filtration efficiency is not less than 95%  Considering that in the Chinese market, medical device products need to meet the relevant national standards. I searched the National Medical Products Administration website for medical device standards related to masks and got the following results. I opened the webpages and checked the standard name of the standard number: YY Medical Surgical Masks. Masks that meet this standard are suitable for clinical medical services. Standard name of disposable masks worn by personnel during invasive operations, etc.: YY/T Disposable medical masks. Masks conforming to this standard are suitable for covering the mouth, nose and jaw of users, and are used in ordinary medical environments. There is also a national standard among the five results of disposable masks that block the oral and nasal cavity exhalation or ejection of pollutants. The standard number is 'GB 19083-2010 Technical Requirements for Medical Protective Masks'. This standard clarifies the scope of application of masks that meet the standard ——It is a self-priming filter medical protective copper mask suitable for filtering particles in the air and blocking droplets, blood, body fluids, secretions, etc. in a medical working environment. Moreover, Article 4.1 of the specification clarifies that masks should not have breathing valves. The standard for low filtration efficiency of masks that conform to the specification is that the filtration efficiency level is greater than or equal to 95%   . '19083-2010 Technical Requirements for Medical Protective Masks' does not necessarily meet the national medical device requirements. In order to prove my idea, I specifically searched for the existence of domestic medical products that meet the KN95 standard using KN95 as a key word on the website of the Food and Drug Administration, but I found nothing.   Considering that everyone said that N95 masks refer to the American standard, even if it is the American standard, if the product is not licensed, it cannot be sold in China. Then I searched for the existence of imported medical products that meet the N95 standard using N95 as a key word on the website of the Food and Drug Administration, and found two pieces of information. That is to say, only two manufacturers of imported n95 medical masks approved by the country meet the national standards. One of them is a product of 3M. The product model is 1860, 1860S   as large as domestic demand. If only imported products are used for supply, I think the country will not allow it. I searched for domestic medical products using medical protective masks as keywords on the website of the Food and Drug Administration, and I got 69 search results. If you search for domestic medical products with masks as keywords, you can get about 500 search results.   To sum up, it means that KN95 masks may not meet the requirements of the State Drug Administration. If they do not meet the 'GBAs for the currently mentioned American standard N95 mask, if the relevant batch number of the country is not available, it cannot be used in clinical medicine.   N95 and KN95 masks may have the same testing requirements, but because the country has special regulatory requirements for the direction of medical equipment, the masks required by the hospital need to meet the medical device standards.  If you want to donate materials to the hospital, please pay attention to donating materials that meet the relevant national medical standards.   I am not a medical professional, and I hope to get more corrections from medical professionals. 15:50 points on the standard 'GB Respiratory Protection Self-priming Filtered Particle Respirator' The new version of this standard should be 'GB Respiratory Protection Self-priming Filtered Particle RespiratorOn July 1, 2005, the standard clauses I quoted were from the 2006 version. Update the following content. Open the Chinese government website to inquire about the standards for masks. There are three technical requirements for medical protective masks. The scope of application of this specification has been mentioned above. In the 'GB/T Technical Specifications for Daily Protective Masks' 》The masks that meet this standard clearly stated are not suitable for respiratory protection products for special industries such as hypoxic environments, underwater operations, escape, fire protection, medical and industrial dust prevention, and are not suitable for infants and children’s respiratory protection products. . 339
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