Packaging materials and systems for medical devices which are to be sterilized - Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods

Packaging materials and systems for medical devices which are to be sterilized - Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods

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1   Scope

This part of the series of EN 868 provides examples of particular requirements and test methods for heat and self-sealable pouches and reels manufactured from paper complying with EN 868‑3 and plastic film complying with clause 4 of this European Standard.
It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards.
As such, the particular requirements in 4.2, 4.3, 4.4, 4.5, 4.6 and 4.7 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1.
Heat and self-sealable pouches and reels specified in this standard are suitable for use as packaging of medical devices which are to be terminally sterilized.
The use of heat and self-sealable pouches and reels as primary packages enables ease of aseptic presentation where it is important for the user to be able to see the contents of the pack before it is opened.