“Essential performance” refers to the achievement of performance of a clinical function, other than that related to BASIC SAFETY, where loss or degradation beyond the limits specified by the manufacture results in an unacceptable risk.
When determining the essential performance of the product, the administrative counterparts shall consider but not limited to the following aspects:
- Clinical safety risk;
- Performance related to diagnosis/treatment/ monitoring;
- 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 the accompanying document (product specification) of the product, and the identified essential performance shall be tested for immunity. If the essential performance is not identified, all functions of the product shall be taken as the essential performance for immunity test.
