Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process. Note: PCD is a global term that encompasses a range of test devices intended to provide a challenge to the sterilization process that is equal to or greater than the challenge posed by the most difficult item routinely processed. A PCD will usually be one of the following:
- A biological indicator (BI) PCD (which may also contain a chemical indicator [CI])
- A BI challenge test tray (which may also contain a CI)
- A CI challenge test pack (which contains a Class V CI, Class VI CI, or an enzyme-only indicator)