BS EN ISO 11138-5:2006 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 and formaldehyde as the sterilizing agent.
Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.
Requirements for work place safety may be provided by national or regional regulations.