New Practice for Preparing and Delivering the Nitrogen Dioxide (NO2) Sterilant to the Chamber
1. Scope
This practice describes procedures, measurement methods, and calculations for preparing a defined concentration of nitrogen dioxide (NO2) sterilant in a dose preparation chamber and delivering it to the sterilization chamber. It applies to sterilization systems that use a dose preparation chamber as an intermediate step for accurate preparation of the sterilant.
Keywords
sterilant dose; dose preparation; gas sterilization; medical device sterilization; N2O4; NO2; nitrogen dioxide
Rationale
The standard is needed to support the use of NO2 sterilization for medical devices. For gaseous sterilization, accurate sterilant dosing is critical to the process and requires the use of a specific set of calculations. These calculations are necessary because NO2 is not an ideal gas, therefore, adding complexity to simple ideal gas calculations.