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

EN 285 for Large Autoclaves
EN 13060 for small Autoclaves

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

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

Quality standards

ISO 9001:2015
ISO 13485:2016
21 CFR 820
Canadian MDR (CMDR)
ATG (Medical Devices)
Brazilian Good Manufacturing Practices
Japanese QMS Ordinance