Low | 合法醫療器材資訊網

Commonlyusedtestorganismsincludevegetativebacteria,mycobacteria,andsporesofBacillusspecies.Theavailabledatademonstratethatlow-temperature​ ...

Sterilization processes used in the United States must be cleared by FDA, and they require that sterilizer microbicidal performance be tested under simulated-use conditions904. FDA requires that the test article be inoculated with 106 colony-forming units of the most resistant test organism and prepared with organic and inorganic test loads as would occur after actual use. FDA requires manufacturers to use organic soil (e.g., 5% fetal calf serum), dried onto the device with the inoculum, to represent soil remaining on the device following marginal cleaning. However, 5% fetal calf serum as a measure of marginal cleaning has not been validated by measurements of protein load on devices following use and the level of protein removal by various cleaning methods. The inocula must be placed in various locations of the test articles, including those least favorable to penetration and contact with the sterilant (e.g., ...