Patient Leakage ISO 7176-14 vs. IEC 60601-1:2005 Reporting Requirements

D

drasweet

#1
:bigwave: This is my very first post here...however I use this website a lot as a resource.

:frust:I am really stuck on one point that I need to address prior to submitting my response for additional information to the FDA.

I am hoping someone can shed some light on the reporting requirements for ground leakage for a powered wheelchair that I am trying to receive 510(k) clearance for.

A little background:

  • The wheelchair is CE marked.
  • The controls for the device have 510(k) clearance.
  • The patient leakage testing was done to ISO 7176-14 no actual values available just "pass" or "fail
  • FDA says that IEC 60601-1:2005 3rd Ed. requires the reporting of actual values. However the device wasn't tested to this standard according my client.
My questions are:

Given the information above do I actually have to report actual ground leakage values to the FDA based on the fact that the device was tested to ISO 7176-14 (a recognized standard)?

Can some please tell me what ISO 7176-14 requires for ground leakage and what must be reported?


Thank you in advance for any input. :cfingers:
 
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