BS EN ISO 11138-5:2017

This standard BS EN ISO 11138-5:2017 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 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.