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ISO122: Compliance questions for medical certification

Part Number: ISO122
Other Parts Discussed in Thread: ISO124, AMC1350

Hello,

My customer has the following questions:

We’re attempting to certify our device to the latest IEC 60601-1 Ed 3.2 and since this part is not rated for double protection (only single via UL 1577), knowing the following will determine possible paths forward.

  • Type of insulation inside the package between isolation capacitors on opposite ends of the package?  Air gap or other material?
  • Thickness of this insulating layer, or if air the distance between the isolation capacitors.

Typically DTI is in the newer isolation devices, but the ISO122 doesn't have this specification. Also, I imagine that inside the package there are series SIO2 caps and that in between there is mold compound and not any air gap. 

Let us know and thanks! 

John