IEC 60601-1 - Medical Electrical Equipment Safety
Clause 14: programmable electrical medical systems – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 14.5: 14.5 Problem resolution

Where appropriate, a documented problem resolution system is set up and kept up, covering every life cycle phase and activity and the handovers between them; it may sit within the life cycle documentation, and it lets anyone report a problem, actual or suspected, that bears on basic safety or essential performance, assess each problem's risks, set the criteria for closing an issue, and identify the action to resolve each problem.

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