What is the difference between non-sterilized surgical masks and medical masks and the same sterilized masks?
According to the standard YY 0469-2011 for surgical masks, which was issued in 2011, there are two kinds of microbiological indexes: non-sterile and sterilized/sterile.No e. coli, Pseudomonas aeruginosa, Staphylococcus aureus, streptococcus hemolyticus and fungi are allowed to be detected without asepsis.Aseptic, of course, is the inability to detect microbes.In addition, the requirements for bacterial power efficiency (BFE) and fluid penetration are the same for both types of masks.
Under normal circumstances, medical masks are basically sterilized and sterilized with ethylene oxide.Ethylene oxide is toxic, and masks can take 14 days to resolve before they can be used, which is fine in normal years.But demand for medical masks at the peak of the epidemic this year has reduced requirements for secondary indicators.On the one hand, the sterilization cycle is too long on epidemic such as fire not (relevant departments also try to use electron beam irradiation sterilization, but found that material rapidly aging after sterilization, BFE can reduce half), on the other hand, a large number of emergency channels for examination and approval of new set up no antiseptic ability of enterprise, and had to compromise, so on the market to see a large number of non sterilization mask, including disposable medical and medical surgery, medical protection.
The Guizhou Provincial Drug Administration said in a February announcement that it would implement emergency approval:
"During the epidemic prevention and control period, non-non-sterile masks, protective suits and other products manufactured by enterprises shall, on the premise of meeting relevant national or industrial standards, submit an application for temporary production of urgently needed products for epidemic prevention and control to the provincial Drug Administration.Such products should be limited scope (scope limited to: the province the protective isolation demands medical environment, the special purification medical environment, and does not apply to all sterile operation, invasive operation and invasive operation), at the same time should be: epidemic emergency use of health care, in ordinary medical environment, non sterile, and clearly marked in the instruction manual, label.The enterprise should formulate a special production batch number management system and report it to the local municipal medical device regulatory department for the record."
Masks protect health care workers from occupational leakage on the one hand, and protect patients from infection caused by infectious agents exhaled by health care workers on the other.Non-sterilized indicators can theoretically protect medical workers.In addition, because there is no special pathogenic bacteria, the general operation and environment are applicable, such as outpatient clinic, general ward and some clinics can be performed debridement, small wound suture and so on can be used non-sterile type.The operating room has not been in very much, if the sterility requirement is strict, it is better to change the sterilization.
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