Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic port?

T

titanius

#1
Hello Everyone, i have a question.

We have this handheld device (class II) that is powered by an alkaline battery for a 510k. It also has a USB port that is strictly for offline downloading of data by connecting to a computer (and in no way can be used to charge the device) and at that time the main device screen (that shows vital) is disabled.

With regards to 60601-1-2 (4th ed) & 510k, what should be the possible test modes:
1. An internally powered handheld device - we already considered and it passed 60601-1-2.
2. Do we have to EMC test the data downloading through the USB as a separate mode?
OR
Can we argue (for not doing this is) that the port is strictly for offline data transfer and put cautions/warnings in the instructions instructing users (along with risk analysis,etc)? And if the user does it anyways and connects to a USB charger/computer it shows a screen to disconnect USB (and disables showing the current vital values). Will that be sufficient?

Thank you for reading ! Any insights are most appreciated!
 
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somashekar

Staff member
Super Moderator
#2
Re: Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic p

Due to Good Friday and Easter Sunday holidays, you may find some delay in response. Please wait, till some 60601 experts here will come up with a response....
Thanks for joining Elsmar and WELCOME to the Cove.
 

shimonv

Trusted Information Resource
#3
Re: Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic p

Hello Everyone, i have a question.

We have this handheld device (class II) that is powered by an alkaline battery for a 510k. It also has a USB port that is strictly for offline downloading of data by connecting to a computer (and in no way can be used to charge the device) and at that time the main device screen (that shows vital) is disabled.

With regards to 60601-1-2 (4th ed) & 510k, what should be the possible test modes:
1. An internally powered handheld device - we already considered and it passed 60601-1-2.
2. Do we have to EMC test the data downloading through the USB as a separate mode?
OR
Can we argue (for not doing this is) that the port is strictly for offline data transfer and put cautions/warnings in the instructions instructing users (along with risk analysis,etc)? And if the user does it anyways and connects to a USB charger/computer it shows a screen to disconnect USB (and disables showing the current vital values). Will that be sufficient?

Thank you for reading ! Any insights are most appreciated!
Hi titanius,
I am not an expert on EMC test but this is my two cents worth:
Your argument plus risk analysis plus mitigation makes sense providing that the offline download does not occur in the patient environment. I don't know what the workflow is but if you are near the patient while downloading you should - in concept - check for immunity and interference.

-Shimon
 
M

MedMartin

#4
Re: Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic p

Hi Titanius,

best is to talk to your test house for their opinion.

For the designs I was involved we tried to test all modes of the devices.
One design was very similar to yours, a handheld and no measurement while USB connected. We tested also in the USB communication mode as we considered the data transfer critical for immunity. And emission testing is also necessary.

The 4th edition of the 60601-1-2 also recommends testing e.g. in standby modes which would also support testing USB communication mode.

Best regards
Martin
 

VinceTech

Involved In Discussions
#5
Re: Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic p

Hi,

If the USB is not restricted to be used by operator or patient, it's SIP/SOP. Then EMC test shall include it. If USB is restricted only to be used for engineering 'for example, for development or factory use', it maybe exempt from EMC test.

Regards,
 
T

titanius

#6
Re: Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic p

Thank you VinceTech, MedMartin, shimonv, somashekar!

:thanx: so much! this helps a lot.

Your arguments totally make sense. The test house didn't recommend data download mode due to the 'development nature' of the connection.Maybe I might need to rethink about this.
 
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