What is a Technical File?
The Technical File (TF) comprises relevant information, which must demonstrate that all requirements of the Directive(s) have been satisfied. The Technical File must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced. The Technical File is also technical proof for the manufacturer, his authorised representative or the importer that serves as a defence with regard to liability claims. The contents of the Technical File has been established in accordance with the concerning products.
Which documents are in the Technical File?
Basically, the Technical File comprises:
- 1. A general description of the product;
- 2. Sometimes a risk assessment to determine which safety and health requirements apply to the product;
- 3. Design and production drawings;
- 4. Detailed technical drawings about the essential aspects of the product;
- 5. A list with the essential health and safety requirements that were met;
- 6. Report of performed calculations and tests;
- 7. Certificates and inspection reports;
- 8. User’s manual;
- 9. For series production, the internal stipulations that were complied with to guarantee conformity with the Directive(s)
Which information should be in the safety instructions?
The safety instructions are first of all part of the user’s manual. One may also expect that the safety instructions are hung up in the vicinity of the machines. The safety instructions contain every kind of instruction that is necessary for a safe use of the product. Which demands exactly depends on the type of product.
Which information should be in the user’s manual?
The New Approach Directives directly relate to the user’s safety. The information given to the user plays an essential role in reducing or avoiding safety risks. Drafting and providing the instructions with regards to user manuals is a legal, fundamental safety requirement. The user’s manual must contain all information required for a correct and safe use of the product.