Quality assurance

Tuttnauer does not only comply with the strictest international standards and directives. As a member of the European Committee for Standardization, we actively develop and define them.
International autoclave standards

Europe
EN 285 for Large Autoclaves
EN 13060 for small Autoclaves

USA
ST8 Hospital Sterilizers
ST55 - Small Sterilzers

Directives Guidelines

Medical Device Directive - MDD 93/42
Pressure Equipment Direcives - 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