Sterilization

Because microbial kill is exponential, sterility is expressed as a probability rather than an absolute. Changes to the sterilization method or site can affect a 510(k) or the notified body certificate, so they go through change control.

A validated process used to render product free from viable microorganisms. NOTE: In a sterilization process, the nature of microbial inactivation is described as exponential and, thus, the survival of a microorganism on an individual item can be expressed in terms of probability. While this probability can be reduced to a very low number, it can never be reduced to zero.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology