Sterilization requirements for single-use sterile medical supplies are

According to the State Food and Drug Administration announced, the sterilization requirements for disposable sterile medical supplies for, sterile medical devices refers to the product does not have living microorganisms, is a medical device manufacturing enterprises in a sterile state to provide medical device products, is a medical institution, the public do not need to carry out sterilization and direct use of sterile medical device products. The sterile medical device manufacturer establishes different levels of production clean environment according to the requirements of "Good Manufacturing Practice for Medical Devices", and requires strict control from raw materials, production process, personnel hygiene, cleanliness of equipment, materials, and human flow, so as to control microbial contamination to the acceptable level stipulated in the standard. Sterilization is to kill all living microorganisms (including pathogenic microorganisms and non-pathogenic microorganisms, reproductive or spore microorganisms) by physical and chemical methods. The sterility of a sterile medical device is not absolute, but only minimizes the probability of microbial survival. The current standard for the probability of sterilization of sterile medical devices is set at 10-6, or one in a million. Common sterilization methods for medical devices include moist heat sterilization, radiation sterilization, ethylene oxide sterilization and so on. The sterilization requirements should follow the corresponding national standards.