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BQ27Z758: Compliance with IEC60601-1 for implantable medical devices

Part Number: BQ27Z758

Tool/software:

Hi everyone,

Can BQ27Z758 be used as the protection IC in implantable medical devices?

The IC is going to interface a Li-ion battery.

Any challenges in obtaining compliance with IEC 60601-1?

If the part poses risks for compliance with IEC60601-1, can you please recommend an alternative part, and provide an explanation why BQ27Z758 is lacking?

Thanks in advance!