SSH EN 868-5:2009

Materialet dhe sistemet e ambalazhmit për pajisjet mjekësore të cilat janë për t’u sterilizuar - Pjesa 5: Qese dhe rulona me mbyllje me të nxehtë dhe të vetë hermetizueshme prej letre dhe konstruksion filmi plastik - kërkesat dhe metodat e provës

Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

Scope

This part of EN 868 provides test methods and values for sealable pouches and reels manufactured from
porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4
used as 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 to 4.5 can be used to demonstrate compliance with one or more
but not all of the requirements of EN ISO 11607-1.
The materials specified in this part of EN 868 are intended for single use only.
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.

Related directives

Directives related to this standards.