DS/EN 868-9:2009
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

Standard No.

DS/EN 868-9:2009

Release Date

2009

Published By

Danish Standards Foundation

Latest

DS/EN 868-9:2009

Replace

DS/EN 868-9-2000

Scope

This part of EN 868 provides 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.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 4.3 can be used to demonstrate compliance

DS/EN 868-9:2009 history

• 2009 DS/EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods