Partial list of standards and direcctives:

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
  • 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