Device Dossier

Surgical instrument washer/disinfector (chemical/thermal)

Device Dossier for Surgical instrument washer/disinfector (chemical/thermal) (Surgical instrument washer/disinfector (chemical/thermal), Class IIb,…

Intended purpose

Intended for use in a medical context such as a clinic or medical and dental practices as a washer-disinfector intended for reprocessing medical instruments prior to their re-use or a further reprocessing step such as sterilization in a steam sterilizer. Thermostable medical instruments (i.e. instruments which are heat resistant to a temperature of 95 °C) and invasive thermostable instruments can be subjected to automatic reprocessing as long as they are suitable for this purpose and have been approved for such treatment by their manufacturer. The cleaning is performed using water in combination with a process agent. Subsequent disinfection is thermal disinfection. This device is not intended to be used in a patient environment.

TGA Public Summary