Partial list of standards and directives:
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
- ISO 9001 - Quality Management Systems
- ISO 13485 - Quality Management System – Medical Devices
- 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)
- 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
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