Validation of ethylene oxide-sterilization using a new measuring system.

Up to now the parametric release of medical devices sterilized with EO was not possible due the lack of an online method of measurement for EO. With the developed mobile system it is possible to measure all physical parameters of the sterilization process online in the chamber. The accuracy of the EO concentration and humidity measurement is < +/- 1%, of the temperature < +/- 0.05 degree C and of pressure < 0.5% of the measured value.