ABSTRACT

This chapter provides a perspective on human factors standards for medical devices with special consideration of accessibility. A perspective is provided by reviewing the evolution of these standards for medical devices. This is followed by consideration of the relationship of human factors standards to accessibility and, especially, to the determination of the intended users for the product. It is suggested that current standards can best be described as sympathetic to accessibility concerns, but not focused on them, and that a companion set of guidelines on making medical devices accessible would be valuable.