MDD 93/42 Annex I 12.3 - Medical Device Electrical Alarm Requirements

S

s.oguz

#1
Dear All;
The essential requirements of the MDD directive part 12.3 says that:

" Devices where the safety of the patients depends on an external power supply must include an alarm system to signal any power failure."

does that mean all electrical medical devices connected to the mains supply, must include an alarm system which will operate when the electricty went off.?

Thank you
 
Elsmar Forum Sponsor

rob73

looking for answers
#2
Your risk analysis should tell you whether the patient is at risk (or how much risk) should a power failure occur, if they are then that would drive your decision.
 
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