GB/Z 44877-2024

This standard provides guidance on implementing parametric release for ethylene oxide sterilization of medical devices, allowing release of sterilized products based on monitoring and control of critical process parameters (e.g., temperature, humidity, gas concentration) rather than routine biological indicator testing. It is applied by medical device manufacturers and sterilization facilities to streamline quality assurance for EO sterilization processes, particularly for products where parametric release is validated and regulatory approval is obtained. The standard supports compliance with international sterilization norms and reduces reliance on destructive testing while maintaining sterility assurance.