Technical File
The technical file is the file kept by the manufacturer that holds together the design information, risk assessment, applied standards and test records of a product bearing the CE marking. It is the basis of the product's claim of conformity; it is kept ready to be presented to the competent authority upon request.
Although the file's contents vary according to the product type and the legislation it falls under, it typically contains the following headings:
- General description of the product, intended use and foreseen conditions of use.
- Design documents: schematic, board files, bill of materials and component information.
- Risk assessment and the measures taken.
- The list of applied standards and the test reports made according to those standards.
- User manual, label and warning texts.
- Declaration of conformity and, if any, correspondence with third-party bodies.
Which legislation a product falls under and which tests are required depend on the product's function, supply type and operating environment; this scoping work is done at the start of the project. Saying "it is certified according to such and such a standard" before the scope is clear is not correct. The file is kept up to date for as long as the product is in the field: board revisions, software versions and manual changes are worked into the file.
The context in which this term is used: Our Services