We manufacture autoclave sterilizers (high temperature and pressure steam sterilizers) and plasma sterilizers (low temperature H2O2 sterilizers) that provide consistent, high quality sterilization results. Tuttnauer’s global experience has earned it a reputation as an expert on worldwide Standards and Quality considerations. Moreover, Tuttnauer plays an active role in the European Standards Committee which engages in Standards development. Tuttnauer offers comprehensive training programs and services to support the sterility assurance process (which we provide at international locations worldwide). As experts in sterilization and infection control products and processes, we understand the market’s varying needs and comply with the strictest international standards and directives: International Autoclave and Sterilizer Standards: Europe: EN 285 for Large Autoclaves EN 13060 for Small Autoclaves USA: ST8 – Hospital Steam Sterilizers / Autoclaves ST55 – Small Table Top Steam Sterilizers / Autoclaves Directives Guidelines: Medical Device Directive –MDD 93/42 Pressure Equipment Directives – 97/23 WEE & RoHS Directives – 2002/95, 96 FDA Clearance Safety and EMC Standards: IEC/UL/EN61010-1 EN 61010-2-040 EN 61326 Pressure Vessel Construction Standards: ASME Code PED 97/23 Good Practice Standards: ISO 13683 ISO 11134 ST46, ST42 EN554 Quality Standards: ISO 9001: 2008 ISO 13485:2012 21 CFR 820
