What is a sterile medical device? Sterile medical devic […]
What is a sterile medical device?
Sterile medical device refers to a non-viable microorganism on the product. It is a medical device product provided by a medical device manufacturer in a sterile state. It is a sterile medical device product that is directly used by medical institutions and the public without sterilization.
What are the sterilization requirements for sterile medical devices?
Sterile medical device manufacturers shall establish different levels of production clean environment according to relevant regulations, and strictly control the raw materials, production process, personnel hygiene, equipment cleanliness, materials, human flow, etc., so that microbial pollution is controlled to the standard. Acceptable level.
Sterilization is the physical and chemical process to kill all living microorganisms (including pathogenic and non-pathogenic, reproductive or spore-type microorganisms). Sterility of sterile medical devices is not absolute, but minimizes the probability of microbial survival. The current sterilization probability standard for sterile medical devices is specified as 10-6, which is one in a million. Common sterilization methods for medical devices include moist heat sterilization, radiation sterilization, and ethylene oxide sterilization. The sterilization requirements should be in accordance with the corresponding national standards.
What should you pay attention to when using sterile medical devices?
Disposable products are prohibited from being reused. Used sterilized instruments must be destroyed according to regulations, so that their parts no longer have the function of use, disinfected and treated, and recorded. Sterile products must be sterilized and used within the expiration date. If the single package is damaged and the sheath is detached, it is forbidden to use and is disposed of. The use of the product must strictly follow the aseptic technical procedures. The product should be stored in a ventilated, dry room with a relative humidity of less than 80%.
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