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
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