At present, for a machine to be marketed within the European Union, it must have the CE Marking. To obtain this requirement, it is necessary to submit a technical report demonstrating that It complies with all health, safety, and environmental requirements. established in the EU Machinery Directive.
Therefore, the technical file for CE-marked machinery must reflect the following elements:
Design and manufacturing documentation
The first thing that must be present in the technical file for machines for CE Marking is the design and manufacturing documentation.
This must include the machine's plans and technical specifications, as well as the results of tests and trials carried out during its manufacture. In addition, it is important to include any regulations or standards applicable to its design and manufacture, such as the standard EN ISO 12100:2010 About machinery safety.
2. Risk Assessment
Another element that must be included in the technical file for machines for CE marking is the Risk assessment. It must identify the risks associated with the use of the machine, such as the risk of injury from trapping, cuts or blows. Likewise, measures must be taken to minimise these risks, such as the inclusion of safety devices on the machine.
It is important to mention that the risk assessment must be carried out by a machinery safety expert and subsequently documented in the technical file.
3. Instruction and maintenance manual
Among the most important elements that must be in the technical file of machines for CE Marking is the instruction and maintenance manual.
This documentation must provide detailed information on the use and maintenance of the machine, as well as the safety procedures to be followed to avoid injury or damage. It is important that it is clear and understandable for users, and that it is available in several languages to ensure its accessibility.
In summary...
The technical file for CE marking of machinery is an essential document for ensuring the safety of people and their surroundings; the more complete and accurate it is, the easier it is to determine that the machinery complies with the safety, health, and environmental requirements established in the EU Machinery Directive and to obtain CE marking.
It's important to remember that meeting these requirements is not just a legal obligation, but also an ethical responsibility to ensure that the machinery is 100% safe.
At Grupo TICE, we have highly qualified experts who will assess the risks of your machine and create a complete technical file that meets the necessary requirements for marketing it within the EU. Leave it in our hands and you can be sure that your machine will comply with the safety requirements of the ISO 12100 standard.
Contact us and we will provide you with the advice you need on the technical file for CE marking machinery. We will carry out all the procedures, arrangements and adaptations on your machinery to the Achieving CE Marking for industrial machinery.
