Partial list of standards and directives:
Pressure Vessel
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
- PED 97/23/EC - Pressure Equipment Directive
- 2002/96/EC WEEE and 2002/95/EC RoHS
Standards
- AAMI/ANIS ST-5, 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