Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German and English version prEN 868-2:2024
Abstract
This part of EN 868 provides test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.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. This document specifies test methods and values for sterilization wrap made of - single-use creped paper - single-use nonwoven materials - reusable woven textile materials 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 specifies materials, test methods and values that are specific to the products covered by this document.
Begin
2023-03-03
WI
00102179
Planned document number
DIN EN 868-2
Project number
06302213
Responsible national committee
NA 176-03-07 AA - Sterile supply
Responsible european committee
draft standard
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German and English version prEN 868-2:2024
2024-05
Order from Beuth Verlag
