GB/T 18281.8-2024 Sterilization of health care products—Biological indicators—Part 8:Method for validation of a reduced incubation time for a biological indicator
1.1 This document specifies the requirements for test methods used to establish or determine a shorter cultivation time for biological indicators, which is shorter than the 7-day reference cultivation time stipulated in GB 18281.7-2024 for monitoring the biological indicators of wet heat or ethylene oxide (EO) sterilization processes.
Note: For biological indicators used to monitor ethylene oxide sterilization processes, regardless of the product load, the shorter cultivation time described here applies to both 100% ethylene oxide sterilization processes and ethylene oxide mixed gas sterilization processes.
1.2 This document applies to manufacturers of biological indicators (BIs) and end users. If the user's quality system requires it, they need to establish, validate, or determine a shorter cultivation time according to the specified requirements.
1.3 This document does not apply to biological indicators used to monitor dry heat, low-temperature steam formaldehyde (LTSF), and vaporized hydrogen peroxide (VH2O2) sterilization processes.
Note: The method described in this document for monitoring the shorter cultivation time of biological indicators in wet heat or ethylene oxide (EO) sterilization processes has been widely used for many years. However, there is limited experience in establishing a shorter cultivation time for biological indicators used to monitor dry heat, low-temperature steam formaldehyde (LTSF), and vaporized hydrogen peroxide (VH2O2) sterilization processes. Therefore, this document does not include these sterilization processes.
Publish Date: 2024-11-28