Division 2.1.2 The system definition shall address at least the following issues:

system objective (intended purpose);

system functions and elements, where relevant (including human, technical and operational elements);

system boundary including other interacting systems;

physical (interacting systems) and functional (functional input and output) interfaces;

system environment (for example energy and thermal flow, shocks, vibrations, electromagnetic interference, operational use);

existing safety measures and, after the necessary relevant iterations, definition of the safety requirements identified by the risk assessment process;

assumptions that determine the limits for the risk assessment.