BS EN ISO 11138-2:2017

This standard BS EN ISO 11138-2:2017 Sterilization of health care products. Biological indicators is classified in these ICS categories:

• 11.080.01 Sterilization and disinfection in general
• 11.080.20 Disinfectants and antiseptics

This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.

NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937 .

NOTE 2 National or regional regulations can provide requirements for work place safety.