Withdrawn
This part of EN 868 provides test methods and values for paper, used in the manufacture of paper bags
(specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) 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 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 this part of EN 868 are intended for single use only.
NOTE 3 Applicable sterilization methods are specified by the manufacturer.
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
WITHDRAWN
SSH EN 868-3:2009
95.99
Withdrawal of Standard
Oct 23, 2017
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