What testing would you all run to determine if a device is "clean"? What are acceptable levels during those tests for a clean device?
We have asked our regulatory consultants this question, and got a bit of flaky answers. I also haven't seen anywhere that really defines what "clean" is/means.
Take initial bioburden during biocompatibility testing and use that as a baseline for future bioburden levels? Same thing for particulates?
We have asked our regulatory consultants this question, and got a bit of flaky answers. I also haven't seen anywhere that really defines what "clean" is/means.
Take initial bioburden during biocompatibility testing and use that as a baseline for future bioburden levels? Same thing for particulates?