EN 45502 - Protection from HARM to the patient caused by heat

#1
Dear all,

for the following EN 45502 requirement:
In the absence of external influence, no outer surface of an implantable part of the ACTIVE IMPLANTABLE MEDICAL DEVICE not intended to supply heat to the PATIENT shall be greater than 2 °C above the normal surrounding body temperature of 37 °C when implanted, and when the ACTIVE IMPLANTABLE MEDICAL DEVICE is in normal operation or in any single component failure (see 19.3).

How shall I demonstrate the compliance with this requirement : test, fault tree analysis, ...

Thanks in advance

Best regards
 
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#2
I don't work with ACTIVE IMPLANTABLE medical devices, but this strikes me as the sort of basic safety requirement that requires an actual test to determine the effectiveness of the design to meet the requirement.
 
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