GB/T 18281.2-2024 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes

Scope

This document specifies the requirements and test methods for test microorganisms, bacterial suspensions, contaminated carriers, and biological indicators to be used in evaluating the performance of sterilizers and sterilization processes. The sterilizer and sterilization process use pure ethylene oxide gas or a mixture of ethylene oxide gas and dilution gas, with a sterilization temperature range of 29 °C to 65 °C.
Note 1: Requirements for ethylene oxide sterilization confirmation and control are specified in ISO 11135 and ISO 14937.
Note 2: Regulations in some countries or regions may provide safety requirements for workplaces.

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