Standards and Directives The 5075HSG autoclave complies with the strictest international standards and directives: Quality Standards ISO 9001:2008 - Quality Management Systems EN ISO 13485:2012 Quality Management System – Medical Devices In compliance with 21 CFR part 820 & part 11 Directives MDD 93/42/EEC amended in Directive 2007/47/EEC PED 97/23/EC - Pressure Equipment Directive 2002/96/EC WEEE and 2002/95/EC RoHS Technical Standards EN 285: 2006+A2: 2009 Large steam sterilizer EN 13060: 2004+A2: 2010 - Small steam sterilizer 2EN 61010-1: 2010 Safety Requirements for measurement control and laboratory use EN 61326-1: 2006 Electrical Equipment for EMC requirements EN 61010-2-40: 2005 Safety requirements for sterilizers used to treat medical materials EN 17665-1: 2006 Sterilization of health care products – moist heat ANSI \ AAMI – ST 8: 2008 Hospital steam sterilizers ANSI \ AAMI – ST55: 2010 Table Top steam sterilizer ASME Code section I and section VIII. Div.I
