Class 5 integrating indicators for steam sterilization processes.

A chemical integrator labeled as a Class 5 integrating indicator can be used inside each package as an internal chemical indicator to determine that the sterilant has penetrated the package. In addition, a Class 5 integrating indicator inside a PCD (process challenge pack or test pack) can be used for load control to release loads that do not contain an implantable medical device. Class 5 integrating indicators should not replace the use of biological indicators for releasing loads containing implacable, or for routine or sterilizer qualification testing, product testing or for a recall because the response of Class 3 integrating indicators does not correlate to the response of biological indicators under all sterilization process failure conditions. The selection, use and interpretation of Class 5 integrating indicator results will improve the sterilization monitoring process if you use them according to the AAMI ST46 recommended practices and understand their limitations. [ABSTRACT FROM AUTHOR]