Sterilization Process

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