METHOD FOR OBTAINING VALIDATED STERILIZATION PROCESS MEASUREMENTS

    公开(公告)号:EP3808384A1

    公开(公告)日:2021-04-21

    申请号:EP20210450.1

    申请日:2014-03-12

    摘要: A method for obtaining validated sterilization process measurements for the sterilization of a surgical instrument is presented. The method includes the steps of: placing at least one surgical instrument in a container; performing a test sterilization process on the surgical instrument, wherein in said sterilization process, the environment in the container is modified to attempt to sterilize the at least one surgical instrument; while modifying the environment in the container, with a sensor measuring at least one characteristic of the environment in the container and recording the at least one environmental characteristic; after said test sterilization process of the at least one surgical instrument, evaluating the at least one surgical instrument to determine if the at least one surgical instrument was sterilized; if, as a result of said step of evaluating the at least one surgical instrument, it is determined that the at least one surgical instrument was not sterilized: executing a subsequent test sterilization process, wherein, in the subsequent test sterilization process, the sterilization process is modified from the previous test sterilization process; during the subsequent test sterilization process performing said step of measuring the at least one characteristic of the environment in the container; and after said subsequent test sterilization process, performing said step of evaluating the at least one surgical instrument to determine if the at least one surgical instrument was sterilized; and if, as a result of said step of evaluating the at least one surgical instrument it is determined that the at least one surgical instrument was sterilized, recording the measured at least one characteristic of the environment in the container as a validated sterilization process measurement for the at least one surgical instrument.