What is BS EN 868-9 – Packaging for terminally sterilized medical devices about?
BS EN 868-9 is the ninth part of the BS EN 868 multi-series that discusses packaging for terminally sterilized medical devices. This European standard helps its users to verify the quality of packaging products intended for medical devices.
BS EN 868-9 specifies test methods and values for uncoated nonwoven materials of polyolefines used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, BS EN 868-9 specifies materials, test methods, and values specific to the products covered by it.
The materials specified in
BS EN 868-9:2018 history
2019BS EN 868-9:2018 Packaging for terminally sterilized medical devices. Uncoated nonwoven materials of polyolefines. Requirements and test methods
2009BS EN 868-9:2009 Packaging for terminally sterilized medical devices - Uncoated nonwoven materials of polyolefines - Requirements and test methods
2000BS EN 868-9:2000 Packaging materials and systems for medical devices which are to be sterilized - Uncoated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - Requirements and test methods