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