Determining Critical Components for conformity with IEC 60601-1

med_cert

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#21
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?
 
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Ronen E

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#22
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.
The standard doesn't use the term "critical" systematically, except for software, and "critical components" or similar doesn't appear in it at all.
 
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