Helix PCD Test (process challenge device) is used as a daily test for pre-vacuum hospital sterilizers and for bench top steam sterilizers Class B for steam penetration and inert gases. The Helix PCD test is an excellent test to detect even the smallest amounts of inert gases and steam penetration capabilities.
The EN 867 Part 5 is describing a Helix PCD based steam penetration test as an alternative for the Bowie & Dick Test for bench top steam sterilizers Class B the EN 285 is specifying the Helix PCD test for hospital steam sterilizers when it is mainly used to sterilize hollow loads.
Helix PCD test is not replacing routine monitoring of sterilization cycles. This should be done by lot control sets and/or with in pack integrators.
There are different types of indicator according to the sterilization process selected: Steam, Ethylene Oxide and Hydrogen Peroxide. If the all bars change to the final color, the result is successful, so the sterilizer is working correctly. If one bar is different to the final color, it shows a bad sterilizing agent penetration, therefore an equipment malfunction.