DS/EN ISO 11138-4
Sterilization of health care products – Biological indicators – Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
|Publication Date:||4 April 2017|
|ICS Code (Disinfectants and antiseptics):||11.080.20|
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 dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C. NOTE 1 - Requirements for validation and control of dry heat sterilization processes are provided by ISO 14937. NOTE 2 - Requirements for work place safety may be provided by national or regional regulations.