The definition of the device's essential performance: the clinical functions whose loss or degradation beyond limits would cause unacceptable risk, with the limits that apply.
Requirements Work product in the Medical electronics and medical device chips lifecycle
IEC 60601-1 requires the manufacturer to identify essential performance, and testing must show it is maintained, for example during EMC immunity tests. A clear definition lets test laboratories judge pass or fail and closes a gap in the risk management file.
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