ÖNORM EN 868-8

This Part of the series of EN 868 provides examples of particular requirements and test methods for re-usable containers for steam sterilization. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards. As such, the particular requirements in 4.2 to 4.7 can be used to demonstrate compliance with one or more but not ail of the requirements of Part 1. The containers specified in this part of the standard are intended to be used as a packaging System during the sterilization of medical devices in steam sterilizers conforming to EN 285 and the subsequent transportation and storage of those devices. NOTE 1 : When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the User. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle e. g. operating temperature.