When you identify critical components based on the Risk analysis, what is the further action? Do you have more strict incoming inspection or something similar?
Maybe the following (from IEC 60601-1 Ed. 3.1 Annex A) can provide some clues:
[...] These capacitors are safety critical since they provide a leakage path to earth or across a barrier. So they must be certified and monitored by a recognised test house to IEC 60384-14, which serves to control their manufacture.
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