1.1 General 1.1.1 This part of ISO 11138 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. 1.1.2 This part of ISO 11138 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.NOTE National or regional regulat
EN ISO 11138-1:2006 history
2017EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
2006EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements