This part of 11140 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads).
NOTE: The Bowie and Dick Test is used for routine testing of steam sterilizers and validation of steam sterilization processes (see EN 285 and ISO 17665). An indicator complying with this part of 11140 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This part of 11140 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in this part of 11140 is intended to identify poor steam
penetration but does not indicate necessarily the cause of this poor steam penetration.
This part of 11140 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.