MOPP for commercial USB Key

Hi, I'm designing a new medical device with my team and I need a clarification about MOPP needed in this scenario:

Class I (eletric risk) with the metal enclosure connected to PE. An internal Power Supply with 2MMOP (input-output) and NO MOOP/MOPP output to ground.
The output supplies a Personal Computer (inside the enclosure) but the USB Port accessible for an external operator.
The USB key is commercial so I can't say anything about insulation,
so I need an additional MOPP (so 500Kv), correct?
Morover I have SIP/SOP on PC, so I have to ad an additional MOPP, right?
So in this case 2 MOPP (1000KV ) for a voltage @5V below 42V according table 6?

Thanks to all can help me.

Hello Frank, there are some typos in your original post that hamper the final understanding of the matter. Can you address those?

Meanwhile, you can find great posts about the use of USB connectors in medical devices, an example is this one.
Annex J of the Standard is also valuable, you may check it.

Hi Felipe, thanks.

Hi, I'm designing a new medical device with my team and I need a clarification about MOPP needed in this scenario:

We have a class I medical Equipment (basic insulation + Protective earth) with the metal enclosure connected to protective earth. Inside there is medical power supply with 2MMOP (input-output) and NO MOOP/MOPP from output (VDC) to ground.
The output of medical power supply (+12V) supplies a single board computer (inside the enclosure).

On a panel on the metal enclosure of the device we have a USB Port (coming from the single board computer) accessible by an external operator (He can download some data).
The USB key that the operator might use is commercial (and not provided by us) so I can't say anything about insulation.
We have to consider that the plastic cover of a commercial USB key is a "short circuit" exposing the internal USB voltage (+5Vdc). Right?

So I need an additional MOPP (so 500V), so an insulation for the USB port, correct?

Meanwhile I'm reading the thread you suggested.

Frank, you meant 2MOPP when you typed MMOP, right?

What is the type of applied part that you have?

Right 2MOPP.
We're insulating a frontal USB port according the possibility the operator will touch the USB Key and patient (Applied part according Clause 4.6 (BF)).

What I'm trying to understand how manage the other USB ports in the back of the device.
We have to manage a commercial USB key for which I cannot say anything about insulation and we're talking from operator perspective.
The operator is exposed to a 5Vdc.

In this case for the operator will we apply the Table 6?
so for a voltage below 60Vdc and a secondary circuit I've no test according Table 6?


I hope you can help me to solve my doubts.
Franco

Ok I found the solution for the rear USB. According 8.4.2.4 c) in my risk managment report I can say that is not likely that operator touch patient and the rear USB memory stick at the same time (real scenario).

But for the frontal USB according clause 4.6 for which is likely the operator touch patient is very hard to find the MOPP nedeed.
We must consider it similar to applied part.
I need only 1 MOPP @12V and so 500V (according Table 6? similar to B Applied part?
Someone said (in other thread) 2 (???)

I need 1 MOPP@250V and so 1500V (according Table 6) similar to xF Applied part?

In the Figure J6 and J7 for Annex J there are 2 different scenarios:
* 2MOPP at working voltage
* 1 MOPP at maximum mains voltage

I'm a rookie, but let me to say it's absolute tricky.
Please help me!

Frank this is also my conclusion and the conclusion in the other thread that I indicate to you.

I am also going for something close to what you are proposing in another medical device.

May you answer to this?

In the Figure J6 and J7 for Annex J there are 2 different scenarios:
* 2MOPP at working voltage
* 1 MOPP at maximum mains voltage