1. Scope

Keywords

Rationale

The standard is needed to support the use of NO2 sterilization for medical devices. Because the NO2 sterilization process involves chemical reactions that occur inside the sterilization chamber, it is important to provide methods for how to verify and monitor critical process parameters, especially NO2 concentration and percent relative humidity. Providing clear guidance on how to assess the accuracy, repeatability, and control of these parameters will help ensure consistent and reliable performance of NO2 sterilization systems.