ISO 14160:2011 specifies requirements for the characterization of a liquid chemical sterilizing agent as well as the development, validation, process control, and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices containing animal-derived materials in whole or in part.
ISO 14160:2011 addresses the danger of contamination with bacteria and fungi through the use of a liquid chemical sterilizing method. The risks associated with other microorganisms must be evaluated.
ISO 14160:2011 does not apply to human-made materials.
ISO 14160:2011 does not include procedures for validating virus and transmissible spongiform encephalopathy (TSE) agent inactivation.
ISO 14160:2011 does not include methods for validating protozoa and parasite inactivation, elimination, or elimination and inactivation.
The validation and routine control standards provided in ISO 14160:2011 apply solely to the prescribed sterilization process of a medical device, which occurs after the manufacturing process, and do not account for the fatal effects of additional bioburden reduction steps.
ISO 14160:2011 does not prescribe tests to determine the impact of any chosen sterilization process on the medical device's fitness for use.
ISO 14160:2011 does not address the residual sterilizing agent level in medical equipment.
ISO 14160:2011 does not define a quality management system that controls all stages of production.
