ISO/AWI TS 25443

Sterilization of health care products — Moist heat — Guidance for verification of a process challenge device (PCD) to a specific load configuration ISO/AWI TS 25443

Scope

This document gives guidance for the selection of a defined process challenge device (PCD) for moist heat sterilization processes which, in terms of penetration behaviour for the sterilizing agent (steam, or moist heat), is intended to represent a challenge equivalent or greater than a load or a load configuration when using the defined sterilization cycle.
NOTE The defined sterilization cycle used in this document is defined by the production sterilization cycle to be evaluated. The relationship of PCD to medical device and suitability of the PCD to process is only valid for processes and cycles evaluated in accordance with this document.
This document is not applicable for:
a) other sterilization process modalities;
b) the design and execution of type tests according to the currently published sterilizer standards i.e., EN 285 and EN 13060;
c) the material selection and/or design of PCDs;
d) other properties of PCDs which do not influence sterilizing agent penetration;
e) the selection of master product and product families used in validation for the sterilization process.