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 manufactures and users.
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 nor 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.
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, 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.
Directives related to this standards.
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market