Sterile medical devices refer to the medical devices provided by medical device manufacturers in a sterile state without viable microorganisms on the products,

and the sterile medical devices directly used by medical institutions and the public without sterilization.

Aseptic medical device manufacturers should establish a clean production environment of different levels according to the requirements of the

"quality management standard for medical device production", and strictly control the raw materials, production process, personnel hygiene,

equipment cleanliness, materials and flow of people, so as to control microbial pollution to the acceptable level specified in the standard.

Sterilization is the use of physical and chemical methods to kill all living microorganisms

(including pathogenic microorganisms and non-pathogenic microorganisms, reproductive or spore microorganisms).

The sterility of sterile medical devices is not absolute, but merely reduces the probability of microbial survival to a minimum.

The current standard for sterilization probability of sterile medical devices is 10-6, that is, one in a million.

The common sterilization methods of medical devices include wet heat sterilization, radiation sterilization, ethylene oxide sterilization, etc.

The sterilization requirements shall comply with the corresponding national standards. (source: state drug administration)