EN 868-4:2009

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   Feb 8, 2017


CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

11.080.30   Sterilized packaging



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Part 3 of EN 868 provides test methods and values for paper bags manufactured from paper, 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 4.6 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 legislation

Legislation related to this standard


Medical devices


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

Life cycle


EN 868-4:1999


EN 868-4:2009
99.60 Withdrawal effective
Feb 8, 2017


EN 868-4:2017