IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 11 to 13: temperatures, fire, outputs, hazardous situations and fault conditions – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 12.4: Protection against hazardous output

What does 12.4 require?

The risks from hazardous output are addressed in the risk management process where applicable: the intentional exceeding of safety limits; the need to indicate parameters associated with hazardous output, such as quantitative indication of energy, rate or volume before delivery to a patient or a flashing yellow light during X-ray output; accidental selection of excessive output on multi-purpose units offering low- and high-intensity outputs; and incorrect output, for instance through an alarm on significant departure from the set delivery. Equipment producing diagnostic or therapeutic radiation makes adequate provision to protect patients, operators, others and sensitive devices from unwanted or excessive radiation, particular standards specifying requirements, limits and tests; diagnostic X-ray equipment complies with IEC 60601-1-3; radiotherapy equipment and other diagnostic or therapeutic radiation equipment address their risks in the risk management process; and so does diagnostic or therapeutic acoustic pressure.

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