On the producing or consuming side? FWIW, I found the article interesting as I'm starting a new Oxygenator project so I'm probably about to become even more familiar with IEC60601 :-(
I get that, but it's very unlikely to happen. The benefit of your code vastly outweighs the potential downside. As engineers, we're used to only hearing about the problems. It's really gratifying when you hear from someone who says, "tell your engineers that they saved my life."