Device Dossier

Sterilizer, moist heat, wrapped goods

Device Dossier for Sterilizer, moist heat, wrapped goods (Sterilizer, moist heat, wrapped goods, Class IIb, sponsor Eco Jemss). ARTG record, intended…

Intended purpose

PROHS Horizontal Steam Sterilisers use steam inside a vessel under pressure to eliminate all living microorganisms, by controlling the temperature and pressure. Through fast and uniform heat transference, the steriliser can sterilise packaged medical devices i.e. RMDs and surgical instruments. The PROHS Horizontal Steam Sterilizer is designed for sterilization of materials used in healthcare facilities (surgical instruments, textile accessories, infusion fluids, rubber products, etc). The steriliser is designed for fast, efficient sterilisation of heat-and moisture-stable materials in addition to sterilisation of items for immediate use. It is not suitable for the sterilisation of items which can’t be submitted to steam and temperatures between 121°C and 134°C.

TGA Public Summary