DS/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


Status:
Current
Type:
Standard
Language:
English
Subject:
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Scope

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.


Number of pages: 22

Published: 2019-01-10

Date of approval: 2019-01-02

International relationships : EN 868-5:2018 IDT

ICS: 11.080.30 - Sterilized packaging

Item number: M317152


Committees

Committee

  • CEN/TC 102
  • CEN/TC 102/WG 4

Danish committee

DS/S-259