Förpackningsmaterial för medicintekniska produkter avsedda för sterilisering i sluten förpackning - Del 2: Steriliseringspapper - Krav och provningsmetoder
This part of EN 868 provides test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
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 the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1.
As such, the particular requirements in 4.2 can be used to demonstrate compliance with one or more but 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, drying or aseptic presentation (e.g. inner wrap, container filter, 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, may apply.
The materials specified in 126.96.36.199 to 188.8.131.52 of this part of EN 868 are intended for single use, the materials specified in 184.108.40.206 are intended for reuse.
NOTE 3 If the intended purpose according to the manufacturer of the material for sterile barrier system specifies the use as sterile field, then the additional requirements of the EN 13795 series apply.