ANSI/AAMI/ISO 11140-5:2007/(R)2025

Specifies requirements for an indicator and alternative test system used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles. The air removal test is used to evaluate the efficacy of air removal during the pre-vacuum phase of a prevacuum sterilization cycle or during the pulsing stage of positive pulsing cycles if non-condensable gases were present in the steam. Retention of air due to an inefficient air removal stage or the presence of an air leak or non-condensable gases during the air removal stage are circumstances which can lead to failure of the test. This part of ISO 11140 describes the requirements for Class 2 indicators for Bowie and Dick-type air removal test sheets and packs. Annex 2