ISO 11138-1

ISO 11138-1: Sterilization of Health Care Products – Biological Indicators

Another standard we follow, as a biological indicator manufacturer, is ISO 11138-1.  This is titled “Sterilization of health care products – Biological indicators”.  According to the standard, “This part of ISO 11138 specifies general requirements for production, labeling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for…