ISO 60601-1-2 : classe IIb device, distance to pacemaker..

Bryan Ye

Starting to get Involved
How do you conclude that "in that case, labeling could not reduce the risk score (as a single mitigation) "?

Risk assessment needs to be conducted under the intended use, and warning labels are a further emphasis on the intended use environment and user population.
Otherwise, you need a lot of buttons like this to confirm that it cannot be used outdoors, cannot be used in water, cannot be used on infants/pregnant women, etc.
Have you ever seen such medical products?
 
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