Tuttnauer pressure vessels are both ASME and PED certified. All ASME certified vessels are inspected by an independent authorized ASME inspector. Directives & Guidelines: EN 285:2016+ Large Steam Sterilizer 2012/19/EU WEEE and 2002/95/EC RoHS Directives 2014/30/EU, Electromagnetic compatibility 2014/35/EU Electrical Equipment Directive 2006/42/EC Machinery Directive 93/42/EEC for medical devices (amended in Directive 2007/47/ EEC) EN 17665-1: 2006 Sterilization of health care products – moist heat ANSI / AAMI – ST 8: 2013 Hospital steam sterilizers (large sterilizers) Safety and EMC Standards 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: 2013 Electrical Equipment for EMC Requirements EN 60529:1991 Degrees of protection provided by enclosures (IPX4) Pressure Vessel and Steam Generator Construction Standards 2014/68/EU Pressure Equipment Directive ASME Code, Section VIII, Division 1, unfired pressure vessels ASME Code, Section I, for boilers Quality System Compliance ISO 9001:2008 - Quality Management Systems EN ISO 13485:2012 Quality Management Systems – Medical Devices Management System – Medical Devices In compliance with FDA QSR 21 CFR part 820 & part 11 Canadian MDR (CMDR) SOR/98-282 (2015), consolidated
