IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 9 to 10: mechanical and radiation hazards – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 10.1: 10.1 X-Radiation

Equipment that can emit ionising radiation although it is not meant to produce X-radiation for diagnosis or therapy does not exceed an air kerma rate of 5 microgray per hour at 5 cm from any surface an operator other than service personnel can reach without a tool, is given access to or is instructed to enter, allowing for background, measured with a 10 square centimetre ionisation chamber or equivalent at whichever rated mains voltage is least favourable, with controls set for maximum radiation in normal use, with the annual exposure made acceptable where the intended use keeps the equipment permanently near a patient; and for equipment designed to produce X-radiation, unintended radiation is reduced as far as possible through the applicable particular and collateral standards (IEC 60601-1-3) or, failing those, the risk management process, intended radiation being covered by 12.4.5.

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