ISO 11138-1:2006提供生物指标的生产，标签，测试方法和性能特征的一般要求，包括接种的载体和悬浮液及其组分，用于灭菌过程的验证和常规监测.ISO 11138-1 :2006规定适用于ISO 11138的所有后续部分的基本和共同要求。特定特定工艺生物指标的要求在ISO 11138的后续部分提供。如果没有提供特定的后续部分，本部分适用

ISO 11138-1:2006 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.ISO 11138-1:2006 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.