Risk assessment is the process through which the manufacturer identifies potential hazards of the machinery, quantifies the risk related to the machinery’s use, and determines the necessary solutions to address that risk—when required. The Machinery Regulation (EU) 2023/1230 has introduced important innovations, stating that risk assessment should also include potential updates or future developments of the software, subsequent to the market placement or putting into service of the machinery. It should also consider risks that may arise throughout the entire lifecycle of the machinery, due to its expected behavioural evolution, ensuring safe operation at different levels of autonomy. These aspects are not addressed by the Machinery Directive 2006/42/EC.

The risk assessment must be developed and archived in the technical file. The main technical standards covering this topic are:

• EN ISO 12100 Safety of machinery – General principles for design – Risk assessment and risk reduction
• ISO/TR 14121-2 Safety of machinery – Risk assessment – Part 2: Practical guidance and examples of methods

The manufacturer is free to adopt the methods or principles he considers most appropriate for assessing machinery risks. EN ISO 12100 is a harmonised standard, ensuring the presumption of conformity with essential health and safety requirements. Additionally, it explicitly refers to ISO/TR 14121-2 for practical risk assessment. By following these standards, the manufacturer can be confident in meeting the requirements of both the Machinery Directive 2006/42/EC and the Machinery Regulation (EU) 2023/1230.

EN ISO 12100 describes the general principles for risk assessment and reduction, suggesting aspects that the manufacturer should assess. It can also be a useful research tool: those unfamiliar with the specific technical standard applicable to a given aspect of machinery design should search for it through dedicated online portals or seek third-party consultancy. This technical standard is divided into intuitive thematic chapters, mostly referring to essential safety requirements. As a Type-A standard, it does not provide specific technical solutions to particular problems; however, it frequently cites Type-B or -C standards that do. Therefore, it can be extremely useful for quickly and independently identifying the relevant technical standard references. While it does not cite all the potentially applicable standards for the countless aspects of machinery design, the most important ones are included.

ISO/TR 14121-2 is a technical report—as indicated by the English abbreviation “TR” preceding its identification number—which outlines practical methods that enable the manufacturer to quantify risks. It provides tools that translate the characteristics of a specific activity into numerical values or graphical pathways, concluding whether it is sufficiently safe or too risky.