The content of the technical file for machines is described in letter A of Annex VII of Directive 2006/42 / EC and must include the following elements, as described in our book "How to apply the Machinery Directive 2006/42 / EC and the standards reference " .
General description of the machinery
The technical file must contain a description of the machine detailed enough to make it clear its constitution, its limits (especially in the case of complex systems), its intended use; in the general description of the machine it is also advisable to specify which materials can be processed by the machinery, the processes carried out, the interactions of the operators with the machine.
Overall drawing of the machinery
The booklet must contain the overall drawing of the machine and the diagrams of the control circuits, as well as the relative descriptions and explanations necessary to understand the operation of the machine
The overall drawings must represent the machine as a whole and give a precise idea of how it is composed; in particular, safety equipment should be indicated - guards, active optoelectronic protective devices, emergency stop commands, etc. - and their positioning; the diagrams of the control circuits must include all types of energy used by the machine, such as electrical, pneumatic, oil-hydraulic, steam, etc .; the descriptions and explanations necessary to understand the operation of the machine must refer in particular to the machine control circuits and especially to their parts having safety functions .
Detailed drawings, calculation notes, test results
The file must contain detailed and complete drawings, possibly accompanied by calculation notes, test results , certificates, etc., which allow the verification of the conformity of the machine with the essential safety and health protection requirements.
The technical file must not contain all the drawings and detailed projects of the machine, but only those that are necessary to demonstrate its compliance with the essential safety and health protection requirements of Annex I of the Machinery Directive, such as for example drawings of the guards with dimensions and their positioning with respect to the elements that must be protected; also the calculation notes must not be available for all the constituent elements of the machine, but only for the elements whose failure could cause risks, such as for example the eccentric shaft of a mechanical press or a walkway intended to be crossed by people.
The documentation relating to the risk assessment
The dossier must contain the documentation relating to the risk assessment and must demonstrate the procedure followed to carry it out.
The technical dossier should in fact contain a description of the procedure followed for the risk assessment which includes an illustration of the rules adopted for the identification of the hazards, the estimation of the risks and their weighting, including the criteria for determining the achievement of a '' adequate risk reduction; the documentation relating to the risk assessment must include:
- a list of the essential health and safety requirements applicable to the machine: the technical file must contain the list of essential safety and health protection requirements of Annex I of Directive 2006/42 / EC applicable to the machine; all the essential requirements contained in Annex I should be listed, explicitly specifying when these are not applicable;
- the protective measures implemented to eliminate the hazards identified or to reduce the risks and, where appropriate, an indication of the residual risks associated with the machine: the measures adopted to eliminate the dangers or to reduce the risks and any residual risks remaining after the adoption of such measures must be indicated in the technical file; these measures should be associated with the essential health and safety requirements mentioned above, in order to demonstrate how these are met by adopting adequate measures; if standards are used in the definition of safety measures, they should be mentioned: if the standards used are harmonized, the aspect covered by the standard enjoys the automatic presumption of conformity with the requirements of the machinery directive covered, therefore it is sufficient to mention the standard - or its points - used as a reference and describe how the machine satisfies it.
Information on the standards and other technical specifications applied
The dossier must contain indications on the standards and other technical specifications applied, which indicate the essential safety and health protection requirements covered by these standards.
If standards have been applied - harmonized or not or other technical specifications (of users of the machines, of the manufacturer, of trade associations, etc.) - these must be referred to in the technical file and cited where appropriate (as indicated in the previous point) to demonstrate compliance with the essential health and safety requirements of the directive; if only parts of these documents are used, it must be specified.
The dossier must contain any technical report providing the results of the tests carried out by the manufacturer himself or by a body chosen by the manufacturer or his authorized representative.
Technical reports can be included in the technical file - for example, check lists certifying the fulfillment of the requirements of particular standards - or results of tests carried out by the manufacturer or by a Notified Body chosen by him.
These tests may, for example, include measurements of the airborne noise emitted by the machine, measurements of the level of vibrations transmitted from the machine to the operators, safety tests of the electrical equipment of the machine, verification of the sterility of a food packaging machine, etc. .
The instructions for use are part of the accompanying documents of the machine and must be contained in the technical file.
If translations of the instructions for use of the machine are made, the technical file should contain the versions in all languages, as it could be useful in the future to check the content of the translations in case of problems or disputes.
Copy of the EC declaration of conformity
Similarly to what has been said above for the instructions for use, the EC declaration of conformity is also part of the accompanying documents of the machine and must be contained in the technical file.
If translations of the EC declaration of conformity of the machine are made, the technical file should contain the versions in all languages , as it could be useful in the future to check the content of the translations in case of problems or disputes.
Declaration of incorporation for partly completed machinery
Where applicable, the dossier should include the declaration of incorporation for the partly completed machinery included and the associated assembly instructions.
In fact, if the machine incorporates partly completed machinery, the relative declarations of incorporation and assembly instructions of the respective manufacturers must be included in the technical file.
Copy of the EC declaration of conformity of other machines
Where applicable, the dossier should include a copy of the EC declaration of conformity of the machines or other products incorporated in the machine.
In a completely similar way to what has been said above, if the machine incorporates other machines inside it, the relative EC declarations of conformity and instructions for use of the respective manufacturers must be included in the technical file;