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Hello,
We have nearly exhausted of all our options in trying to pass ESD test (as per IEC 60601-2-25 section-202.6.2.2) on our device without success
ME EQUIPMENT may show temporary DEGRADATION during discharges. Within 10 s the ME EQUIPMENT shall resume normal operation in the previous operating mode, without loss of any OPERATOR settings or stored data, and shall continue to perform its intended function and maintain ESSENTIAL PERFORMANCE.
My Question is:
What are my chances to argue to the FDA that our device with its intended use, is OK to fail the 10 seconds recovery requirement? Our device survives the ESD events but it resets.
What are my chances to getting FDA to accept this limitation?
Please share your experience or any valuable advice.
Thanks,