The manufacturer of machinery or a related product shall ensure that a risk assessment is carried out in order to determine the essential health and safety requirements which apply to the machinery or related product. The machinery or related product shall then be designed and constructed to eliminate hazards or, if that is not possible, to minimise all relevant risks, taking into account the results of the risk assessment.
By the iterative process of risk assessment and risk reduction referred to in the first subparagraph, the manufacturer shall:
- a)determine the limits of the machinery or related product, which include the intended use and any reasonably foreseeable misuse thereof;
- b)identify the hazards that may be generated by the machinery or related product and the associated hazardous situations;
- c)estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence;
- d)evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Regulation;
- e)eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b).
The risk assessment and risk reduction shall include hazards that might arise during the lifecycle of the machinery or related product that are foreseeable at the time of placing the machinery or related product on the market as an intended evolution of its fully or partially self-evolving behaviour or logic as a result of the machinery or related product designed to operate with varying levels of autonomy. The risk assessment and risk reduction shall include risks resulting from interactions between machinery in order to achieve the same end that are arranged and controlled so that they function as an integral whole, thus forming machinery as defined in Article 3, point 1, point (d).