IEC 60601-1 Third Edition: The Need for Essential Performance
14 November 2011
Essential Performance is a new requirement to the Third Edition – the performance necessary to achieve freedom from unacceptable risk. Why is this important? Essential performance functions could lead to an unacceptable risk. The IEC 60601-1 Third Edition standard also notes that "essential performance exists when the feature or function in question is either absent or its characteristics are degraded to a point that the ME equipment is no longer suitable for its intended use."
A simplified way of determining Essential Performance is to use the risk management tools and run all the performance functions of the product through risk assessment. Any performance functions that are determined to be acceptable risks can now be classified as performance functions. The remaining functions are what the standard is referring to as Essential Performance. Some examples of essential performance functions are diagnostic functions, surgical functions, alarms, and the performance functions in the particular standards for medical products.