Every machinery, piece of equipment or component must be approached with an integrated design beyond just general functionality, in compliance with the essential safety requirements. The Machinery Directive 2006/42/EC is the foundation of the process for placing safe and reliable machinery on the market, providing a comprehensive and unambiguous assessment process and technical risk mitigation actions. The stages of the development of a technical file are generally specified in the following points.
- IDENTIFICATION: Machinery, partly completed machinery or equipment.
- LIMITS OF USE, LIFE CYCLE AND STAKEHOLDERS: Intended use in the different stages (transport and handling, installation, use, maintenance, decommissioning) and authorized personnel.
- TYPE OF CERTIFICATION: The EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII; the full quality assurance procedure provided for in Annex X.
- RISK ASSESSMENT AND REDUCTION: Applicable risk assessment system in Annex I of the Directive and according to UNI EN ISO 12100:2010. This tool is used to determine the mitigating actions for the project in order to comply with the essential safety requirements.
- GOVERNING RULES: application of unified type C standards for design choices involving presumption of conformity.
- ANALYSIS OF SECURITY SYSTEMS: According to UNI EN ISO 13849:2016, the designs of security system architectures are assessed according to the 'Performance Level' required by the case.
- USER AND MAINTENANCE MANUAL: It is the document that accompanies the machinery throughout its life cycle and contains all the information necessary for safe use.
- DECLARATION OF CONFORMITY: It is the document certifying that the machinery complies with the directives
- CE MARKING: It is an indelible plate fixed to the machinery that identifies it and indicates its conformity.
- ATTACHED DOCUMENTATION: It refers to the file attached documents showing that the design and implementation are consistent with the analyses carried out, such as: structural checks, executive drawings, fluidic diagrams, electrical diagrams, material certificates, component datasheets, safety component certificates, safety data sheets, worker training modules (D.Lgsl 81/08) and any other document evidencing the process.