Standards and Directives

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
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