System Definition

Must address at least:

• system objective (intended purpose);

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

• system boundary including other interacting systems;

• physical (interacting systems) and functional interfaces;

• system environment (e.g. energy and thermal flow, vibrations, electromagnetic interference, operational use);

• existing safety measures – and the definition of any additional identified safety requirements;

• assumptions that determine the limits for the risk assessment.