This part of EN 868 provides test methods and values for paper used in the manufacture of preformed 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 4.3 can be used to demonstrate compliance with one or more
but not all of the requirements of EN ISO 11607-1.
Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of
pouches and form and fill packs and lidding material for packs.
NOTE 2 The paper specified in this part of the series EN 868 is suitable for the manufacture of sterile barrier systems
to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce
coated paper according to EN 868-7.
NOTE 3 Paper according to EN 868-3 can also be used for these sterilization processes.
The materials specified in this part of EN 868 are intended for single use only.
NOTE 4 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 filters, 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.
Legislation related to this standard
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