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The Process Challenge Devices (PCD) for ethylene oxide sterilization processes have been developed according to the standard EN 1422. The PCD consists of a 4.55 m long stainless-steel tube of 3 mm diameter connected with a capsule holding the indicator strip or self-contained biological indicator (SCBI) sealing one end. The capsule and the SCBI are designed with extreme narrow lumen to fulfil the requirements of EN 1422
