Due to advancing technology, and a constant stream of new medical products being developed and entering the medical marketplace, the IEC 60601 series of medical standards exists in an environment of ongoing and rapid change.

Amendment 2 seeks to achieve several key objectives:

  • Prioritize risk management and risk mitigation throughout the entire product design process.
  • Address foreseeable hazards and minimize the impact of user error by employing a robust evaluation and usability engineering process throughout the design and development of the user interface.
  • Ensure that software components, common to so many types of medical electrical equipment, meet standards in their life-cycle development process.

This guide provides an overview of some of the key changes within these standards.