Standards and Directives

Tuttnauer manufactures autoclaves according to Pharmaceutical standards/directives required by our customers. The following is a partial list of the standards and directives supported by Tuttnauer:

Quality Standards

  • cGMP
  • ISO 9001:2008 - Quality Management Systems
  • EN ISO 13485:2012 Quality Management System – Medical Devices

Directives

  • PED 97/23/EC - Pressure Equipment Directive
  • 2002/96/EC WEEE and 2002/95/EC RoHS
  • 2006/42/EC Machinery directive
  • 6002/59/EC Electrical equipment
  • 2004/108/EC Electromagnetic compatibility
  • GAMP

Technical Standards

  • DIN 58950-2:2011 Steam sterilizers for pharmaceutical products
  • ASME Code section I and section VIII. Div.I
  • ASME BPE2009 for Pharma
  • EN 285: 2006+A2: 2009 Large steam sterilizer
  • ANSI \ AAMI – ST 8: 2008 Hospital steam sterilizers
  • IEC 61010-1: 2010 Safety Requirements for measurement control and laboratory use
  • IEC 61010-2-40: 2005 Safety requirements for sterilizers used to treat medical materials
  • EN 61326-1: 2006 Electrical Equipment for EMC requirements
  • EN 17665-1: 2006 Sterilization of health care products – moist heat
  • EN 554 Validation and routine control
  • In compliance with FDA QSR 21 CFR part 820 & part 11