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EVS-EN 868-5:2018

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

General information

Valid from 03.01.2019
Base Documents
EN 868-5:2018
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.01.2019
Main
07.08.2009
Main

EN 868-5 specifies test methods and values for sealable pouches and reels manufactured from porous materials. These sealable pouches and reels are used as sterile barrier systems or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

EN 868-5 specifies materials, test methods and values that are specific to the products. The materials specified are intended for single use only. General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1. The EN 868 series can be used to demonstrate compliance with one or more of the requirements specified in EN ISO 11607-1.

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