FIELD: aseptic assembly of a multicomponent (composite) medical device.
SUBSTANCE: method for aseptic assembly of a multicomponent medical device is characterized by that: a) preparing a first component of a medical device in a first container, and a second medical device component located in the second container, each of the separate containers having a tearable portion, b) sterilizing the first component in the first container by a first sterilization method, and second component in second container by second sterilization method, wherein first and second sterilization methods are selected different from each other from group, consisting of gas sterilization, radiation sterilization and thermal sterilization, c) connecting the first and second containers, combining their ruptured sections one above another in a place, aseptically isolated from the environment, d) one of the components is moved through the ruptured sections and aseptically assembled components to form a medical device in the form of a sterile package. At least one of the first and second containers has a flexible wall through which at least one of the first and second components is manipulated to form a medical device. Also disclosed is an aseptic kit for a multicomponent medical device.
EFFECT: group of inventions provides simple implementation of separate sterilization of system components, preservation of operability and reliability of sterilized components, as well as reduced costs.
17 cl, 7 dwg
