What is Process challenge device (PCD)?

A PCD is the new term for challenge or test packs. It is a term that is part of the International Standards Organizations (ISO) documents and is now used in the Association for the advancement of Medical Instrumentation (AAMI) recommended practices and standards. You will not routinely see this name as part of a commercially available challenge or test pack because it is a new term but be assured that commercially available products labeled as challenge or test pack are PCDs. For this in-service the term test pack/PCD will be used.

A test pack/PCD is “designed to designed to simulate product to be sterilized and to constitute a defined challenge to the sterilization process and used to assess the effective performance of the process. In other words the test pack/PCD creates a challenge to the sterilization process representative of load contents but presents the worst case. In addition it is placed in the sterilizer in the location that creates the worst-case or greatest challenge to sterilant penetration. A PCD is a challenge test pack or test tray that contains a biologic indicator, a Class 5 integrating indicator, or an enzyme-only indicator.


In 2003, the Association for the Advancement of Medical Instrumentation (AAMI) published a Technical Information Report (TIR), AAMI TIR31, 2003 Process challenge devices/ test packs for use in health care facilities, to provide technical information to healthcare facilities in the selection and use of process challenge devices (PCDs).

The PCD inside the load are the Internal PCD’s (IPCD) and those outside are called External PCD (EPCD). The Internal PCD is representing the product, while the External PCD is a standard item used by the sterilization company as a control during the routine sterilization process.

The challenge is to demonstrate that the BI’s in the Internal PCD are killed more easily than the BI’s in the External PCD. This is checked during a separate “sub-lethal” cycle in which the sterilization cycle is too short to kill all of the million bacteria of the BI’s. When the percentage of kill is larger for the Internal PCD’s than for the External PCD’s, the monitoring of routine production cycles can be performed with External PCD’s only.

Tuesday, Dec 1, 2020

Content source:

Cleaning and disinfection of environmental surfaces in the context of COVID-19- Interim guidance

 Are you capable of answering the Notified Body questions on EO sterilization validation?- QServe Blog

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Process Challenge Devices (RRS 14-11520) (PCD)

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