Hello,
A Hematology cell counter seems to be used in a laboratory environment. The use of the EIC 61236 focusses on electrical equipment for measurement, control and laboratory use, so I gather the use of this standard for this kind of medical device is suitable, taking into account the intended use environment. Note however that you should be knowledgeable about the intended use environment and other equipment used there, to justify your choice of a suitable standard.
In your risk management file you should conclude that the use of this standard is an adequate and suitable endpoint for EMC safety. FDA does not prohibit you to use other than recognized standards, as long you can justify the use of them.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
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Original Message:
Sent: 27-Jan-2020 16:01
From: Anonymous Member
Subject: EMC Testing
This message was posted by a user wishing to remain anonymous
Thanks Richard.
I like to clarify that our risk assessment shows EMC testing is required, but I need to know if and when compliance with EMC standard 60601 is also required for this type of device. EMC 60601 was not part of the original 510K clearance. The device was cleared with EMC 61326 not 60601. Looks like the FDA is requiring testing to EMC 60601 in the new submissions but in our case this is a change to an existing device which was cleared with EMC 61326.
Original Message:
Sent: 26-Jan-2020 08:39
From: Richard Vincins
Subject: EMC Testing
Hello,
It really depends on the change and impact of that change. You would want to go through a risk assessment, evaluation, and impact assessment of this change to an existing cell counter to understand if there is any need or justification for conducting the EMC (EMD) testing again.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 24-Jan-2020 12:17
From: Anonymous Member
Subject: EMC Testing
This message was posted by a user wishing to remain anonymous
Dear all,
What is the FDA expectations in terms of EMC verification for a change to an existing cleared Hematology cell counter (product code GKZ) originally cleared with EMC standard 61326: is verification of EMC conformity with the same standard (61326) acceptable?