During the design and manufacturing of machinery, the machine manufacturer shall identify and evaluate all possible hazards and hazardous points by undertaking a risk assessment (formerly also called a hazard analysis).
Based on this risk assessment, the machine manufacturer shall take suitable design measures to eliminate or reduce the risk. If the risk cannot be eliminated by these design measures or the remaining risk cannot be tolerated, the machine manufacturer shall select and apply suitable protective devices, and provide information on the residual risks if necessary.
To ensure the intended measures work correctly, overall validity is necessary. This overall validation shall evaluate the design and technical measures, as well as the organizational measures in context.