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
  • PED 97/23/EC - Pressure Equipment Directive
  • 2012/19/EU WEEE and EU 2017/2102 Restriction of the use of certain hazardous substances (RoHS Directive)

Standards

  • ST-55, FDA 510K cleared
  • EN 13060 - Small Steam Sterilizerד
  • 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
Need more Information?
Brochure
Download the brochure and learn more about this autoclaves capabilities
Need help choosing?
Ready to place your order? We are here to assist you with any questions you may have.