scope:

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature-steam-formaldehyde as the sterilizing agent. NOTE 1 - Requirements for validation and monitoring of low-temperature-steam-formaldehyde sterilization processes are provided by ISO 14937, Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices. NOTE 2 - Requirements for work place safety may be provided by national or regional regulations.