BS EN 868-5:1999 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
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.
BS EN 868-5:1999 history
1970BS EN 868-5:2018 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
2009BS EN 868-5:2009 Packaging for terminally sterilized medical devices - Sealable pouches and reels of porous and plastic film construction - Requirements and test methods
1999BS EN 868-5:1999 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