ISO - 11138-5
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for lowtemperature steam and formaldehyde sterilization processes
|Publication Date:||1 March 2017|
|ICS Code (Sterilization and disinfection in general):||11.080.01|
This document specifies 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 and formaldehyde as the sterilizing agent.
NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.