Standard: AAMI - 11138-5
STERILIZATION OF HEALTH CARE PRODUCTS—BIOLOGICAL INDICATORS—PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES
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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 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 may be provided by national or regional regulations.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Most Recent Revision:||NO|
|Document #||Change Type||Update Date||Revision||Status|
|AAMI 11138-5||Change Type: COMPLETE REVISION||Update Date: 2017-01-01||Revision: 17||Status: ACTV|
|11138-5||Change Type:||Update Date: 2006-01-01||Status: INAC|