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EN 868-5:2018

Current
Current

The latest, up-to-date edition.

Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Published date

19-12-2018

This document specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4. These sealable pouches and reels are used as 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 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.The materials specified in this part of EN 868 are intended for single use only.

Committee
CEN/TC 102
DevelopmentNote
This standard was just updated in our system however it was originally released on 12-2018
DocumentType
Standard
ProductNote
This standard also refers to en iso 11140-1,en iso 11607-1,
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

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