scope:

1.1 General 1.1.1 This part of ISO 11138 provides general requirements for production, labeling, test methods and performance characteristics of biological indicator systems, including inoculated carriers and suspensions, and their components to be used in the validation and routine monitoring of sterilization processes. 1.1.2 This part of the standard specifies basic and common requirements that are applicable to all subsequent parts of the standard. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of this standard. If no specific subsequent part is provided, this part applies. NOTE - National or regional regulations should be considered.