I must comply with the medical EMC standard IEC 60601-1-2 but wireless modules do not come certified to this standard.
For example, telit fn980 is certified to FCC, RED, etc.
Are FCC certified devices automatically compatible with 60601-1-2?
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1\$\begingroup\$ The simple answer is No, FCC certification of an included radio module does not fulfill the EMC immunity and emission requirements for your medical device. I recommend you get consulting help. \$\endgroup\$– Mark LeavittCommented Nov 30, 2020 at 19:13
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\$\begingroup\$ Thanks, do you know what additional cispr 11 regulations apply to emissions over normal FCC standards? \$\endgroup\$– SeanJCommented Nov 30, 2020 at 19:38
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