Internally powered ME with non-conductive applied parts



Hi All,

We have a device that has 3 x 1.5V button cells powering a single LED that is used to light the work area. The rest of the device is entirely non-conductive plastic.

Is my reading of the standard correct in that the patient contacting parts are still considered Type BF applied parts even though they do not provide any electrical connection and do not impart any form of energy to the patient?

Mark Meer

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That is my understanding.
(we also have similar non-conductive patient-contact parts...our test lab insisted they must be labelled as B (or BF) applied parts).

Also note this only applies to patient contact. When you say "used to light the work area", it sounds like it could be an operator making contact, and not necessarily the patient.


Thanks for this.

The applied part is definitely patient contacting!
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