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