EN 868-7:2009

paper complying with EN 868-6, used as sterile barrier systems and/or packaging systems that are intendedto maintain sterility of terminally sterilized medical devices to the point of use. The materials specified in thispart are intended to be used for ethylene oxide or irradiation sterilization.NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user.This part of EN 868 only introduces performance requirements and test methods that are specific to theproducts covered by this part of EN 868 but does not add or modify the general requirements specified inEN ISO 11607-1.As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or morebut not all of the requirements of EN ISO 11607-1.NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, dryingor aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, trayliners or an additional envelope around the medical device) then other requirements, including the determination of theacceptability of these materials during validation activities, may apply.The materials specified in this part of EN 868 are intended for single use only.