Reusable Medical Device

Post-reuse cleaning methods of reusable medical devices are validated through a series of validation processes implemented in our laboratory. It is the responsibility of our manufacturers to define the cleaning and sterilization processes of reusable medical devices.

Before starting the cleaning process validation studies, risk assessment studies are carried out and protocols are prepared and submitted for customer approval. Studies are carried out on the basis of ISO and AAMI standards.

At what point in the body the medical device is used, the pollutants it may be exposed to and the cleaning agents to be used accordingly are evaluated. Reference pollutants (test soils) are used for cleaning validation studies.

Manual, automatic or manual-automatic washing processes are determined by our manufacturers, and the selection of cleaning agents to be used in cleaning methods is very important.

Cleaning process studies are long-lasting and require detailed processes and must be planned in advance. Demonstrating whether your products are truly clean is about whether test methods are appropriate.

You can contact us for cleaning process validation studies.