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