What should be the contents of the Technical File?
The Technical File shall consist of:
- Overall and detailed plans of the PPE accompanied, if appropriate, by calculation notes and the results of prototype tests in so far as is necessary for the verification of compliance with the Basic Requirements (Annex II of the PPE Directive).
- An exhaustive list of the basic safety requirements and of the harmonized standards or other technical specifications used to demonstrate compliance with the Basic Requirements.
Other technical documentation that should be included, although not strictly part of the 'Technical File' is:
- A copy of the User Information or Instructions for Use supplied with the product.
- A description of the control and test facilities to be used in the manufacturer's plant to check compliance of production PPE with the harmonized standards or other technical specification.