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Except for components where the adequacy of ratings can be demonstrated (e.g. by component manufacturers’ ratings or by the dielectric strength tests of Clause 20) the CREEPAGE DISTANCES and AIR CLEARANCES of insulation between the high-voltage circuit and other parts, and between different parts of the high-voltage circuit, shall be at least 3 mm/kV.
This requirement shall also apply to the isolating means between the high-voltage circuit of the DEFIBRILLATOR and other PATIENT CIRCUITS.