BS EN 868-2:2009 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.

BS EN 868-2:2009 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 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 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.

Cross References:
EN 20187
ISO 187:1990
EN 20535
ISO 535:1991
EN 20811
EN 21974
ISO 1974:1990
EN 29073-3
EN ISO 536
ISO 536:1995
EN ISO 1924-2
ISO 1924-2:1994
EN ISO 2758
ISO 2758:2001
EN ISO 11607-1:2006
ISO 11607-1:2006
EN ISO 13937-1
ISO 13937-1:2000
EN ISO 13938-1
ISO 13938-1:1999
ISO 3689
ISO 3781
ISO 5636-3
ISO 6588-2:2005
ISO 8601
ISO 9197
ISO 9198
ISO 9237
EN 1041
EN 1149-1
EN 13795-1
EN 137952
EN 137953:2006
EN ISO 90739
EN ISO 11607-2
ISO 11607-2:2006
93/42/EEC


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