Our high quality research laboratory autoclaves are designed to comply with the strictest international directives and standards in all aspects of the animal care market.

Technical Standards and Directives

  • 97/23/EC - Pressure Equipment Directive
  • EN 285:2006+A2: 2009 - Large Steam Sterilizers
  • DIN 58951-2:2003 - Steam Sterilizers for Laboratory
  • EN 61010-1: 2001, EN 61010-2-040: 2005, EN 61326-1: 2006
  • ASME Sec. VIII Div.1 and Sec. I, ASME BPE
  • ISO 17665-1: 2006
  • 89/336 - EMC Directive
  • EN 60529:1991 - Degrees of Enclosure Protection (IPX4)
  • ANSI/AAMI ST-8: 2008
  • 2002/95/EC - RoHS Directives
  • 2004/108/EC - Electromagnetic Compatibility
  • 2006/95/EC - Electrical Equipment
  • 2006/42/EC - Machinery Directive

 

Quality Standards

Tuttnauer manufacturing plant meets the following quality standards

  •  ISO 9001: 2008 - Quality Management Systems
  •  ISO 13485: 2003 - Quality Management Systems for Medical Devices
  • Compliance with FDA QSR 21 CFR part 820 & part 11