“Essential performance’ refers to the achievement ofperformance of a clinical function, other than that related to BASICSAFETY, where loss or degradation beyond the limits specified bythe manufacture results in an unacceptable riskWhen determining the essential performance of the product,the administrative counterparts shall consider but not limited to thefollowing aspects:
(1) Clinical safety risk;
(2) Performance related to diagnosis/treatment/ monitoring;
(3) Whether the performance of various sensors,cables,application parts, control devices, display devices, moving parts, etc.are affected by electromagnetic interference.
The essential performance shall be reflected in theaccompanying document (product specification) of the product, andthe identified essential performance shall be tested for immunityIf the essential performance is not identified, all functions of theproduct shall be taken as the essential performance for immunity test.
