Standards and Directives

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 - Quality Management Systems
  • ISO 13485 - Quality Management System – Medical Devices

Directives

  • MDD 93/42/EEC amended in Directive 2007/47/EEC
  • 2012/19/EU WEEE and EU 2017/2102 Restriction of the use of certain hazardous substances (RoHS Directive)

Standards

  • EN 13060 - Small Steam Sterilizers
  • EN 61010-1 - Safety Requirements for measurement control and laboratory use
  • EN 61326-1 - Electrical Equipment for EMC Requirements
  • EN 61010-2-40 - Safety requirements for sterilizers used to treat medical materials
  • EN 17665-1 - Sterilization of health care products – moist heat
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