A method for validating a method for sterilizing an item, making it possible to validate the sterility assurance level achieved with this sterilization method. The method includes carrying out a first step of contaminating a container receiving the item with more than 105 living microorganism cells, then carrying out a first sterilization cycle with the chosen method, then opening the container in order to contaminate it again with more than 105 living microorganism cells, then carrying out a second sterilization cycle with the same method, and finally checking the sterility of the container after the first sterilization cycle and after the second sterilization cycle. The method is applicable in particular for products and devices intended for health use.
