ME system or ME equipment?

Curious_1368

Registered
Hello 60601 experts... :cool:
my question is if we consider clause 8.2.1 requirements, how should I treat my medical device to comply with test cl. 8 basic safety requirements, e.g., leakage, dielectric, CR/CL? treat it as ME System or Equipment? here are some details:

Our medical device (let's call it "X") is an accessory that is intended to receive power from a certified non-medical consumer electronic device (let's call it "end-product" which complies with IEC62368-1/IEC60950-1). X does not have on-board power (no battery). it functions only when connected to the end-product. the power connector interface between X and end-product is proprietary. X receives 5V, 1A, max 5W from the end-product. X is fully enclosed in a non-metallic enclosure, the proprietary power connectors are not accessible to the user while it's powered/operating (while connected to the end-product). There is no applied part, user is considered an operator, and we have 1MOOP. X is not intended to come into contact with the user while powered and installed in place.
The intention is to certify X to IEC60601-1 but not the end-product.

Additional details about the end-product: it has Li-ion rechargeable batteries. End-product works either while batteries are in charge or not. In-box power adapter is provided which complies with IEC62368. User Manual restricts the user to use an in-box PS or any other certified PS to charge the batteries.

Question:
  • For running leakage/dielectric, should I run it on the entire system (X + end-product + power adaptor)? meaning consider it as ME System per clause 8.2.1?
OR
  • Shall I run leakage/dielectric on X only? Meaning consider it as ME Equipment?

my 2 cents: I believe testing X is sufficient, and clause 8.2.1 is not applicable for us.
please let me know if I am missing anything or if you have any questions to discuss further. thank you.
 
Last edited:

FelipeSchneider

Involved In Discussions
Hi Parparf, it is hard to understand how the device should be used when you provide so little detail about its applicability.

Besides that, to better visualize the use scenario, an insulation diagram is of great use.

I would initially say that you have an ME System.
Annex A has some examples and few of them fit your description.
 

Avidan B

System Eng, Medical devices safety&reg. consultant
Hi,

According to the Standard definition (Cl. 8.2.1) ,your system falls under a category of a "ME system".

Indeed, the standard allows to define it as an equipment if the external power is a generic off-the-shelf component. but in your case, the "end product" seems to be a specific device by itself. (BTW, do you sell the end product also to the customer?)

So, my suggestion (to be also on the safe side) is to test the whole system together ( X+end product+power adapter). there should not be problems with that , taking into account that there are no applied parts and you have a plastic enclosure...

what is that power adapter?

Good luck,

Avidan
 

Curious_1368

Registered
Hi Avidan,
yes, we sell the "end product" to the customer as a standalone device (it would be fully functional without "X"). basically X is an accessory/additional part available in order to adapt it to some special use.
the power adaptor is a generic adaptor with 2 prongs, 30W output comes with a USB-C cable, for example you can use it to charge up your phone too. however we provide it as an inbox power adaptor with the "end product" just for the customer's convenience.
It makes sense to me to consider them all together as an ME Equipment however I wonder if having a generic power adaptor may affect this classification, ME equipment vs ME system?

Hi Felipe, sorry I am not able to provide any info on how and what the "end-product+X" is. just to mention that it doesn't have any essential performances.
 

Bryan Ye

Starting to get Involved
Hi, Parparf,

Do you sell the "X" to your Customer?
if yes, then you need a separate report for this "X".
If not, Then the report/Certificate for "X+end product+power supply unit" is enough.

"generic power adaptor" will affect safety a lot, especially for leakage current.

Suggest selling "X+end product+power supply unit" as a package to your customer.

The standard always requires when the ME equipment is used with other equipment, compliance shall be evaluated on the end-use product.
if you sell an "X+end product" to your customer without a power supply unit and your customer has no capability to evaluate the compliance according to IEC 60601 then this is a problem
 
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