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Status : Active
Standard Type : Main
Document No : ISO 11138-5:2017
Document Year : 2017
Pages : 7
Edition : 2
Section Volume : Sterilization of health care products (ISO/TC 198.)
ISO 11138-5:2017 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.