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
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 22.214.171.124 to 126.96.36.199 of this part of EN 868 are intended for single use, the materials
specified in 188.8.131.52 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.
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