Applied Parts Classification Clarification - Breast Pump

[neash83]

Hello,

I am looking for some guidance with regards to applied parts classification.

I have an electric breast pump device that very broadly consists of a mains adaptor, pump unit and breast pump horn (this is in contact with the patient and is connected to the pump via a tube).

Am I correct in assuming the breast pump horn would be an applied part? If so would this be a B or BF classification (I am leaning towards BF)?

Secondly would the breast pump unit be classed as an applied part? This has buttons for switching the device on and changing pump speed.

Thanks

 

[3dBUnderThe Limit]

My short answer would be: BF and class II power supply to avoid fixed installation for home use. This is under the assumption that this is a ME equipment.

A part of the base unit would need to be part of the BF barrier, but that is only a guess and would depend on the implementation of the pump system.