Within ANSI/AMI HE 75:2009, human factors is defined as “the application of knowledge about human capabilities (physical, sensory, emotional, and intellectual) and limitations to the design and development of tools, devices, systems, environments, and organizations”
Within ISO/IEC 62366:2007, usability is defined as “Characteristic of the USER INTERFACE that establishes EFFECTIVENESS, EFFICIENCY, ease of USER learning and USER satisfaction.”
Usability has a broader lens than human factors as it includes ease of use and user satisfaction. Regulatory bodies focus on the application of human factors and usability during product development to generate data and evidence to support the conclusion that the product user interface can be used safely and effectively by the intended users, for its intended uses, and use environments. The term user interface refers to all points of interactions between the product and the user and may include the device and its associated elements such as displays, controls, along with the product’s packaging, product labels, instructions for use, etc.