UNE-EN 868-8:2019

This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285.

NOTE 1 The need for a packaging material inside the container is determined by the manufacturers and users.

Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard.

NOTE 2 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.

NOTE 3 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, can apply.

Secretary remark (to be deleted by formal vote stage): CEN/TC 102/WG 4 proposes to change the Scope of the work item in order to align the scope with the recently published new editions of EN 868-2, "3, 4- "6 and "7. Please consider that a positive ballot on prEN 858-8 during enquiry includes the approval of the revised scope.