DIN Standards Committee Health Technologies
Packaging for terminally sterilized medical devices — Part 5: Sealable pouches and reels constructed of porous materials and plastic film - Requirements and test methods
Abstract
This document specifies test methods and values for single-use sealable pouches and reels constructed of a porous material as specified in EN 868 part 2, 3, 6, 7, 9 or 10 and a plastic film. These sealable pouches and reels are intended to be used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document.
Begin
2024-11-28
WI
00102189
Planned document number
DIN EN 868-5
Project number
17600126
Responsible national committee
NA 176-03-07 AA - Sterile supply