This European Standard specifies the performance requirements for a Class B indicator to be used as an alternative to the Bowie and Dick test for steam sterilizers for wrapped goods (instruments, etc. and porous loads).
An indicator complying with this European Standard incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This European standard does not specify requirements for the test load but specifies the performance of the indicator system in combination with the test load with which it is intended to be used. The indicator specified in this European standard is intended to identify poor steam penetration but does not indicate necessarily the cause of this poor steam penetration.
The Bowie and Dick test is performed to demonstrate conformity of a steam sterilizer for wrapped goods to EN 285 and may be used as a routine test of performance of such a sterilizer (see EN 554). The method of carrying out the test is described in EN 285.
This European Standard 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.