What does a technical construction file consist of?

January 24, 2019 11:38

The CE marking guidelines require the manufacturer of a product to compile a technical file (technical construction file) that demonstrates that the product meets the requirements of the applicable guidelines. In general, a technical file must contain the following documents:

  • Description of the device;
  • Wiring and circuit diagrams;
  • General overview design;
  • List of applied standards;
  • Registration of risk and standard assessments;
  • Description of operating logic;
  • Datasheets for essential subassemblies;
  • Parts list;
  • Copies of existing markings and labels;
  • Copy of instructions (user, maintenance, installation);
  • Test reports;
  • Quality control and commissioning procedures;
  • Declaration of Conformity.