Device Dossier

Sterilizer, moist heat, wrapped goods

Device Dossier for Sterilizer, moist heat, wrapped goods (Sterilizer, moist heat, wrapped goods, Class IIb, sponsor Henry Schein Halas). ARTG record,…

Intended purpose

Intended for use in the medical sector, e.g. in medical and dental practices. The small steam sterilizer is designed according to EN 13060. It uses the fractionated vacuum process to ensure effective steam penetration of the load with saturated steam. It is suitable for reprocessing instruments and materials that may come into contact with blood or body fluids during treatment. The steam sterilizer is not intended for use on patients or in patient care and is not intended for the sterilization of liquids.

TGA Public Summary