Medical Device Marking - Power Input Ports

#1
Looking for recommendation on marking a medical device -specifically the input jack to our device--we use a 12V 15Watt external power supply to power our product. 60601 states "Model or Type of the specified power shall be permanently marked on the outside of the equipment..."
We use a generic medical approved power supply, so "model" wouldn't be appropriate. Is the Type? 12V 1.2A with a marker showing the polarity adequate for the "TYPE"?
What about font size?
Does the marking need to be adjacent to the jack or can it be on a label on the product?
Any help welcome!
 
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philou49

#2
Re: Device Marking Help - Power Input

On our last certification in compliance with 60601-1 we had the same issue and here is what has been approved (We have an external 12V 2.5A power)
On the identification plate : 12V (symbol for DC voltage) 25VA
Near the jack connector: 12V (symbol for DC voltage) + polarity symbol.
But it may be lab dependant.
Note: do your lab accept "generic" medical power supply. Our lab requested that we identified all acceptable power supply in our IFU and to test all of them for power consuption + heat and also EMC (conducted and radiated) !
 

Mark Meer

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#3
Re: Device Marking Help - Power Input

Our experience is the same, with the additional consideration of the Class II symbol (if applicable) as required by 7.2.6.

7.2.6 says "preferably adjacent to the connection point" (emphasis added), so it's a good idea to have a marking by the actual connector.

There is no specific requirement for font-size. ...but of course, it should be legible and permanently affixed.


...do your lab accept "generic" medical power supply.
Good point. Likely the test lab will list the power supply as a critical component. Thus, while your chosen power-supply may have been sourced as "generic", in terms of 60601-1 testing, the power-supply is "specific".
 
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