Patent ID: 7704453
Filing Date: 2010-04-27
Classification: A61L

Abstract:
1. A method for sterilizing objects with radiation, the method comprising the steps of determining a dosage of radiation sufficient to ensure sterilization to a sterility assurance level of 10 −6 and then applying said dosage of radiation to the objects, and wherein the step of determining said dosage includes the steps of: determining a bioburden upon one or more samples of the objects; determining an estimate of the dose that results in a probability of 0.01 of a surviving microorganism on the objects by testing a quantity of samples of the objects at varying dosage levels of radiation to determine a dosage below which not at all samples are sterilized and above which they are sterilized; confirming the estimate of the dose that results in a probability of 0.01 of a surviving microorganism on the objects by testing a quantity of samples of the objects at the dose that was estimated; and calculating a dosage for the sterility assurance level of 10