New Practice for Practice for Residuals Testing and Risk-Based Acceptance Criteria for Chlorine Dioxide Gas Sterilization of Medical Devices
1. Scope
1.1 This practice provides guidance for the assessment, testing, and interpretation of residual chlorine dioxide-related species, specifically chlorine dioxide (ClO2), chlorite (ClO2-), chlorate (ClO3-), and chloride (Cl-), on medical devices sterilized using chlorine dioxide gas.[1,2,18]
1.2 This practice describes recommended analytical methodology using validated ion chromatography methods (such as EPA Method 300.0 or 300.1), risk-based approaches for establishing device-specific acceptance criteria, and the importance of establishing analytical detection limits prior to post-sterilization testing.[9,10,19,20]
1.3 This practice applies to chlorine dioxide gas sterilization processes in which the gas is generated and applied under dry or low-moisture conditions. It does not apply to aqueous chlorine dioxide solutions or liquid chlorine dioxide precursor systems.[1,18]
1.4 This practice does not establish mandatory acceptance criteria. All numerical values presented are illustrative examples derived from published toxicological reference data and conservative exposure assumptions.
Keywords
gas sterilization
Rationale
There is currently no practice to establish residuals limits following chlorine dioxide sterilization; This is an important requirement for establishing a past sterilization safety profile for a medical device.
WK98448 - New Practice for Practice for Residuals Testing and Risk-Based Acceptance Criteria for Chlorine Dioxide Gas Sterilization of Medical Devices | ASTM
