Exclusions or justification for non-applicability of IEC standards

#1
We are about to ship our samples to meet the IEC standards associated with FES medical devices, in relation to IEC 60601 General and collateral testing. If there are requirements that we cannot meet for example the emergency button, can the scope of compliance be omitted or justify why it does not meet? Doesn't that affect obtaining certification?

I was reading in this forum that it is recommended to accredit certain points of the general rule, more subjective points such as PEMS, it was possible to carry out internal documentation and then trace the compliance of said points
 
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yodon

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#2
Meeting standards gives you a presumption of conformity to applicable regulatory requirements. If you don't meet them, you may try to provide a risk-based justification why it wasn't necessary to meet but, indeed, it could certainly result in denial of certification.
 
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