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

Safety and EMC Standards

  • IEC/UL/EN61010-1
  • EN 61010-2-040
  • EN 61326

Pressure Vessel Construction Standards

  • ASME Code
  • PED 97/23

Directives Guidelines

  • RoHS DIRECTIVE 2011/65/EU
  • Waste Electrical & Electronic Equipment(WEEE)-Directive 2012/19/EU
  • Medical Device Directive –MDD 93/42
  • FDA Clearance
  • Pressure Equipment Directives – PED 2014/68/EU

Good Practice Standards

  • EN ISO 17665-1
  • AAMI ST79

Quality Standards

  • ISO 9001:2015
  • ISO 13485:2016
  • 21 CFR 820