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
