EO and Gamma Product Adoption


I have a couple questions regarding product adoption into sterilization families. (not sure if this is the right place to post) What testing is required to adopt a product into a sterilization family?

I have been seeing conflicting reports for ethylene oxide. Some state that with only bioburden results and load density, you can perform a “paper adoption” in which you perform a technical review with no further testing.

I have also read that in addition to bioburden and load calculations, EO residuals and a fractional cycle needs to be performed.

So which is it? Is using a paper adoption method with a technical review, bioburden and Density calcualtion sufficient for product adoption? Or are EO residuals and fractional cycles a must?

Thank you