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Integration of safety aspects in IFMIF-DONES design is a main objective of EUROfusion and European Commission projects. IFMIF-DONES will be a radioactive facility of the first category, and stringent safety objectives must be achieved and demonstrated. A very low acceptable risk for the worker, the public and the environment is the main principle in the design phase. The progress of safety activities is performed iteratively as detailed engineering develops, taking into account the uniqueness of the facility: a high-power deuterons accelerator (125 mA, 40 MeV), a target of flowing liquid lithium, traps for activation products, a dedicated-design module for irradiated samples, a massive shielding cooled room with confinement function, and a number of conventional systems with safety functions. Several phases are developed: (i) identification of sources and materials at risk, radioactive and nonradioactive, subject to potential mobilization, (ii) failure mode analysis and effects of systems, starting at the functional level, and support with probabilistic analysis, (iii) identification of scenarios leading to unacceptable risk if unmitigated, (iv) proposal of layers of defense by means of safety-credited components and design features, (v) deterministic analysis of scenarios in support of requirements, and (vi) definition and demonstration of safety requirements charged to components. [ABSTRACT FROM AUTHOR]