Regulatory Open Forum

Calling all those IEC/EMC experts to weigh in on a technical question (I'm sure a test house could answer as well maybe). If I have an electromechanical medical device (IVD) and it is designed to be connected to an off the shelf computer monitor, what testing would need to be repeated or considered if the monitor (connected to the IVD) is replaced?

My thinking is that the peripheral is certified in its own right with regards to emissions and immunity, changing it for another certified one would not require retesting.

Thanks ahead of time!

Sam

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Samuel Murray
Director, Regulatory Affairs and Quality Assurance
Portsmouth RI
United States
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Samuel,

I used to work at a few test houses as an electrical safety testing expert for medical device but often got involved in these EMC discussions as well. We always informed customers they were correct with there assumptions on the surface; however, you are ultimately responsible for the system you are selling. There are two cases:
1. You do not provide the monitor - In this case the warning in the IFU should cover you in that the end customer has now created a system and it is their responsibility to ensure compliance of the entire system.
2. You do provide the monitor - In this case you, as the manufacturer of the system, are responsible for full compliance of the system.

I'm not sure if any of the interconnecting cables are being switched out as well but that certainty could have an impact.

I've also seen lately the FDA requesting 60601-1 testing on IVD equipment even though the more applicable standard is 61010-1 with 61010-2-101. If your device was tested to 60601-1 the limits and requirements will be different than those for a piece of information technology equipment (the monitor) unless the monitor was tested to 60601-1-2.

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Wade Munsch
Regulatory Affairs Manager
Biotex, Inc.
Houston TX
United States
Website: www.biotexmedical.com
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Original Message:
Sent: 21-Nov-2022 22:48
From: Samuel Murray
Subject: EMC testing and peripherals

Calling all those IEC/EMC experts to weigh in on a technical question (I'm sure a test house could answer as well maybe). If I have an electromechanical medical device (IVD) and it is designed to be connected to an off the shelf computer monitor, what testing would need to be repeated or considered if the monitor (connected to the IVD) is replaced?

My thinking is that the peripheral is certified in its own right with regards to emissions and immunity, changing it for another certified one would not require retesting.

Thanks ahead of time!

Sam

------------------------------
Samuel Murray
Director, Regulatory Affairs and Quality Assurance
Portsmouth RI
United States
------------------------------

Thanks Wade,

As of right now the products were cleared with 61010-1 and 61010-2-101. Since we do provide the full system, I would think a rationale for a monitor that has EMC testing in its own right can be swapped for an equivalent monitor that meets all design inputs. The whole thing is PC driven. Certainly there are other compatibility concerns with the PC, monitor, and instrument together, but just trying to rationalize EMC is not one of them.

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Samuel Murray
Director, Regulatory Affairs and Quality Assurance
Portsmouth RI
United States
------------------------------

Original Message:
Sent: 22-Nov-2022 09:27
From: Wade Munsch
Subject: EMC testing and peripherals

Samuel,

I used to work at a few test houses as an electrical safety testing expert for medical device but often got involved in these EMC discussions as well. We always informed customers they were correct with there assumptions on the surface; however, you are ultimately responsible for the system you are selling. There are two cases:
1. You do not provide the monitor - In this case the warning in the IFU should cover you in that the end customer has now created a system and it is their responsibility to ensure compliance of the entire system.
2. You do provide the monitor - In this case you, as the manufacturer of the system, are responsible for full compliance of the system.

I'm not sure if any of the interconnecting cables are being switched out as well but that certainty could have an impact.

I've also seen lately the FDA requesting 60601-1 testing on IVD equipment even though the more applicable standard is 61010-1 with 61010-2-101. If your device was tested to 60601-1 the limits and requirements will be different than those for a piece of information technology equipment (the monitor) unless the monitor was tested to 60601-1-2.

------------------------------
Wade Munsch
Regulatory Affairs Manager
Biotex, Inc.
Houston TX
United States
Website: www.biotexmedical.com

Original Message:
Sent: 21-Nov-2022 22:48
From: Samuel Murray
Subject: EMC testing and peripherals

Calling all those IEC/EMC experts to weigh in on a technical question (I'm sure a test house could answer as well maybe). If I have an electromechanical medical device (IVD) and it is designed to be connected to an off the shelf computer monitor, what testing would need to be repeated or considered if the monitor (connected to the IVD) is replaced?

My thinking is that the peripheral is certified in its own right with regards to emissions and immunity, changing it for another certified one would not require retesting.

Thanks ahead of time!

Sam

------------------------------
Samuel Murray
Director, Regulatory Affairs and Quality Assurance
Portsmouth RI
United States
------------------------------

You should reference the FDA EMC of Medical Devices Final Guidance issued June 6, 2022.  In it there is a paragraph pretty specific to IVD equipment.

"Most laboratory equipment and in vitro diagnostic devices (IVDs) are outside the scope of 60601-1-2. At the time of the issuance of this guidance, we partially recognize IEC 61326-1:2020 and IEC 61326-2-6:2020 and recommend using the test methods from these standards. However, we recommend using acceptance criteria specific to the device's functions and intended use. Additionally, we recommend using test levels specified by 60601-1-2 or, alternatively, determining the reasonably foreseeable maximum levels of the electromagnetic phenomena in the device intended use environments (e.g., through study of published literature or environmental measurements)."

Note, that IEC 61326-2-6 is in the process of being re-written and FDA was involved in the process.  Since FDA has been involved in the process heavily one of the co-conveners is from the FDA I assume they will likely be in favor of taking the 60601-1-2 references for the IVD paragraph above out of their comment in the guidance but realize they actually put in the limits and requirements of the 60601-1-2 in the 61326-2-6 draft standard.

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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 21-Nov-2022 22:48
From: Samuel Murray
Subject: EMC testing and peripherals

Calling all those IEC/EMC experts to weigh in on a technical question (I'm sure a test house could answer as well maybe). If I have an electromechanical medical device (IVD) and it is designed to be connected to an off the shelf computer monitor, what testing would need to be repeated or considered if the monitor (connected to the IVD) is replaced?

My thinking is that the peripheral is certified in its own right with regards to emissions and immunity, changing it for another certified one would not require retesting.

Thanks ahead of time!

Sam

------------------------------
Samuel Murray
Director, Regulatory Affairs and Quality Assurance
Portsmouth RI
United States
------------------------------