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 Sterilizers
Directives Guidelines
Medical Device Directive - MDD 93/42
Pressure Equipment Directives - 97/23
2012/19 EU WEE & 2011/65/EU RoHS Directives
FDA Clearance
Safety and EMC standards
EN61010-1:2010
EN 61010-2-040
EN 61326-1:2013
Pressure vessel construction standards
ASME Code Section I & Section VII. Div. I
PED 97/23 EC and 2014/68/EU
Good practice standards
ISO 13683
ISO 11134
ST46. ST42
EN554
Quality standards
ISO 9001:2015
ISO 13485:2016
21 CFR 820
Canadian MDR (CMDR)
ATG (Medical Devices)
Brazilian Good Manufacturing Practices
Japanese QMS Ordinance