This document 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.
This document provides high-level requirements and respective test methods that are general in nature.
This document 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.
This document does not supersede or modify requirements or test methods of published standards applying to sterilizers, or future editions thereof.
This document does not apply to:
— sterilizers using radiation as the sterilizing agent;
— sterilizers for laboratory equipment;
— sterilizers used to prepare culture media;
— sterilizers used for bio-decontamination of laboratory or other waste including decontamination of pathogens in a high risk category;
— systems used for bio-decontamination of rooms and isolator systems;
— systems used for sterilization in place; or
— washer-disinfectors.
NOTE Whilst this document provides requirements for sterilizers used in health care applications, there will be elements that are applicable to industrial applications.