Quality Assurance

Sterilization Process

Increasing the effectiveness of the sterilization process involves proper decontamination, daily use of chemical and biological indicators, ongoing sterilizer maintenance, record keeping, staff education and proper instrument preparation practices. These factors are so crucial for efficient and effective sterilization that they have become standardized.
 
Tuttnauer’s global experience has earned its reputation as the expert on worldwide Standards and Quality considerations. We build sterilizers that provide consistent, high quality sterilization results, taking into account all these issues and concerns. Moreover, Tuttnauer plays an active role in the European Standards Committee which engages in Standards development. Tuttnauer also offers comprehensive educational programs and services to support the sterility assurance process. As experts in sterilization and infection control, we best understand the market’s varying needs and comply with the strictest international standards and Directives:

International Autoclave Standards:

 
Europe:

  • EN 285 for Large Autoclaves
  • EN 13060 for Small Autoclaves

 

USA:

  • ST8 – Hospital Sterilizers
  • ST55 – Small Sterilizers

 

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
  • 61010-2-041
  • 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: 2000
  • ISO 13485:2003
  • 21 CFR 820