BS EN ISO 11138-2:2017 pdf.Sterilization Of Health Care Products - Biological Indicators - Part2:Biological Indicators For Ethylene Oxide Sterilization Processes. Iso 11138-1 specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. This document gives specific requirements for those biological indicators...