Your Guide To: IEC 60601-1, 3rd Edition, Amendment 2
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.
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