Standards Development

Scope

This document specifies requirements for test organisms, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers an d sterilization processes employing vaporized hydrogen peroxide as the sterilizing agent.

NOTE 1 Requirements for validation and control of vaporized hydrogen peroxide sterilization processes are provided by ISO 22441 and ISO 14937. NOTE 2 National or regional regulations can provide requirements for workplace safety.

Purpose

Hydrogen peroxide in vapour phase is currently used for terminal sterilization of medical items in health care facilities on a global basis and is also used as a sterilant by medical device and pharmaceutic al manufacturers . Commercially available biological indicators are currently used to valid ate and monitor these processes, however, there are no standard s that specify the testing methods and performance requirements of these biological indicators. ISO 11138-1 specifies production, labelling , test methods and performance requirements for the manufacture of biological in dicators including in oculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. This part o f ISO 11138 will give specific requirements for those biological in dicators intended for use in hydrogen peroxide vapour sterilization processes. EN ISO 11138-6 was developed under VA before. Note: in case the WI is based on documents from other organizations than ISO/IEC , please specify it here