IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 4 to 5: general requirements and testing – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 5.9: Determination of applied parts and accessible parts

What does 5.9 require?

Inspection and the accompanying documents establish which parts are applied parts; inspection establishes which parts are accessible and, where there is doubt, by the standard test finger applied bent or straight without appreciable force in every normal-use position, once access covers are opened and lamps, fuses and fuseholders without a tool or per the instructions, equipment over 45 kg for floor use not being tilted and cabinet-mounted equipment tested in its mounting position, openings resisting the jointed finger being probed with a straight finger at 30 N and, if it enters, retested with the jointed finger, and openings admitting the test hook pulled with 20 N for 10 s perpendicular to the surface; conductive parts of actuating mechanisms accessible after removing handles, knobs and levers count as accessible unless removal needs a tool and the risk management file shows the part is unlikely to detach unintentionally during the service life.

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