Quality assurance for reconditioning of medical devices

Cleaning, disinfection and sterilization of medical devices is, in accordance with legal requirements, to be performed using validated procedures in such a way that the success of these procedures is demonstrably ensured and the safety and health of patients, users and third-party persons is not endangered (German Medical Devices Act, Medical Devices Operator Ordinance)

Performance evaluation within the scope of validation of sterilization processes (DIN EN ISO 17665-1)

  • with moist heat (steam sterilizaion)
  • with low-temperature steam/formaldehyde

Performance evaluation within the scope of validation of cleaning and disinfection processes in automatic reconditioning of medical devices