Medicine
The validation of reprocessing processes is regulated in Germany in §8 MPBetreibV(1): "The reprocessing of medical devices intended for use in a low-germ or sterile state must be carried out using suitable validated procedures, taking into account the manufacturer's specifications, in such a way that the success of these procedures is comprehensibly guaranteed and the safety and health of patients, users or third parties is not endangered." Furthermore, proper reprocessing of medical devices is assumed if the recommendation of the RKI "Hygiene requirements for the reprocessing of medical devices" is observed. Important standards for the validation of cleaning and disinfection processes are the standards DIN EN ISO 15883 and DIN 58341, as well as the standard DIN EN ISO 17665-1 for steam sterilization processes.