IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment. Although if focuses primarily on electromechanical devices, it also applies to aspects of the software components. It is a widely recognized standard that most, if not all, medical device companies have to comply with.
The concept of Essential Performance of a Medical Device is at the center of IEC 60601-1. It is intended to be one of the outputs of the Risk Management Process.
Essential performance is defined as "performance of a clinical function, other than that related to basic safety, where loss or degradation beyond the limits specified by the MANUFACTURER results in an unacceptable risk. NOTE: ESSENTIAL PERFORMANCE is most easily understood by considering whether its absence or degradation would result in an unacceptable RISK".
Essential performance is intended to be a risk-based approach, where failures resulting in unacceptable risks are pointers to essential performance.
But, as required by ISO 14971, unacceptable risk is by definition, well, not acceptable. The manufacturer must mitigate it to bring it to an acceptable level. So, after mitigation, all risk should be acceptable. Does it mean there is no Essential Performance?
To read on, please visit our blog post on IEC 60601, essential performance, safety and risk management.