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This document specifies the performance for a Type 2 indicator system to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous loads)
.NOTE The Bowie and Dick-type test is used for routine testing of steam sterilizers and validation of steam sterilization processes.
An indicator system conforming with this document incorporates an indicator together with a specified material which is used as a test load. This test load may, or may not, be re-usable. This document does not specify requirements for the test load, but specifies the performance of the indicator system (the indicator in combination with the test load with which it is intended to be used). The indicator system specified in this document is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration.
This document does not include test methods to establish the suitability of these indicator systems for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.
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