Standards
Tuttnauer quality systems are ASME certified. All ASME certified autoclaves are inspected by an independent authorized ASME inspector.
- DIN 58951-2:2003 Steam Sterilizers for Laboratory Use
Directives & Guidelines:
- PED 97/23/ECPressure Equipment Directive
- 2002/95/EC RoHS Directive
- 2006/95/EC Electrical equipment
- 2004/108/EC Electromagnetic compatibility
- 2006/42/EC Machinery Directive
- 2002/96/EC WEEE Directive
- ANSI / AAMI – ST55: 2010 Table Top steam sterilizer
- EN 13060: 2004+A2: 2010 Small steam sterilizer
Safety and EMC Standards:
- EN 61010-1: 2010 Safety requirements for laboratory use
- EN 61010-2-40: 2005 Safety requirements for sterilizers
- EN 61326-1: 2006 Electrical Equipment for EMC Requirements
- EN 17665-1: 2006 Sterilization of health care products – moist heat
Pressure Vessel and Steam Generator Construction Standards:
- ASME Code, Section VIII, Division 1, Pressure Vessels
- ASME Code, Section I, for Boilers
Quality System Compliance:
- ISO 9001:2008 (Quality Systems)
- EN ISO 13485: 2012 Quality Management System
- Canadian MDR (CMDR) SOR/98-282 (2011)
- In compliance with FDA QSR 21 CFR part 820 & part 11