ISO/TS 22421 specifies the common requirements for sterilizers used for terminal sterilization of medical devices in health care facilities. This document covers sterilizers that operate with a variety of sterilizing agents (alone or in combination) within a sealed vessel at different temperatures, above, at, or below atmospheric pressure.
ISO/TS 22421 provides high-level requirements and respective test methods that are general in nature.
Note: ISO/TS 22421 does not provide quantitative requirements for process parameters or parameters of the sterilization cycle, or requirements for performance testing, validation, or routine control of sterilizers because these depend on the respective sterilization method.
Note 2: ISO/TS 22421 does not supersede or modify requirements or test methods of published standards applying to sterilizers, or future editions thereof.
ISO/TS 22421 on terminally sterilization medical devices is applicable to:
The use of ISO/TS 22421 guidelines for requirements improves the quality and efficiency of terminal sterilization of medical devices in health care facilities.
A sterile healthcare product is one that must be free of viable microorganisms. International Standards that specify requirements for validation and routine control of sterilization processes requirements. ISO/TS 22421 guidelines help to supply a sterile health care product, which is adventitious microbiological contamination free.
ISO/TS 22421