66 Laboratory Autoclave Standards and Directives

Our high quality laboratory autoclaves are designed to comply with the strictest international standards and directives.

Directives

  • PED 97/23/EC
  • 2006/42/EC Machinery
  • 6002/59/EC Electrical equipment
  • 2004/108/EC Electromagnetic compatibility

Technical Standards

  • EN285: 2006+A2:2009
  • DIN 58951-2:2003
  • ANSI/AAMI - ST 8: 2008
  • EN 61326-1: 2006
  • EN 17665-1: 2006

Quality Management System Standards

  • ISO 9001:2008 and ISO 13485:2003
  • Compliance with FDA QSR 21 CFR part 820 & part 11
  • Canadian MDR (CMDR) SOR/98-282 (2006) consolidated

Markets: 

  • Horizontal-Animal-Care