GB/Z 44877-2024 Sterilization of medical devices—Guidance on using parametric release for ethylene oxide sterilization process

Scope

This document provides guidelines for product sterilization release using a parameter-based release method after the ethylene oxide sterilization process, in order to meet the requirements of GB 18279-2023.
This document is applicable to providing a method for parameter-based release for existing sterilization processes, as well as for developing and implementing parameter-based release standards for new sterilization processes. This document emphasizes the importance and interrelationship of other process factors that affect the reproducibility of the ethylene oxide sterilization process, such as loading methods and equipment performance. Note: For ease of use, the clause numbers in this document correspond to those in GB 18279-2023. Clauses that are consistent with GB 18279-2023 are described as "not specified or additional guidance provided", while clauses that are inconsistent have corresponding content added or modified. This document is not applicable to biological indicators. For qualified statements of sterilization cycles that include the requirement that biological indicators show no microbial growth, this document does not provide additional guidance.

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