All pressure vessels and boilers are certified according to ASME code section I and section VIII, Div. I and PED 97/23/EC - Pressure Equipment Directive
Quality Standards
ISO 9001:2008 - Quality Management Systems
EN ISO 13485:2012 Quality Management System – Medical Devices
Directives
MDD 93/42/EEC amended in Directive 2007/47/EEC
2002/96/EC WEEE and 2002/95/EC RoHS
Standards
AAMI/ANSI ST-55:2010, FDA 510K cleared
EN 13060: 2004+A2: 2010 - Small Steam Sterilizer
EN 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
