Standards and Directives

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