DS/EN 868-5:2018

Pakkematerialer til terminalsteriliseret medicinsk udstyr – Del 5: Svejsbare poser og ruller fremstillet af porøst materiale og plastfilm – Krav og testmetoder


Status:
Gældende
Type:
Standard
Sprog:
EN
Kategori:
Pris fra:
kr. 423,00

Beskrivelse

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.


Antal sider: 22

Udgivet: 2019-01-10

Godkendelsesdato: 2019-01-02

Internationale relationer: EN 868-5:2018 IDT

ICS: 11.080.30 - Sterilemballage

Varenummer: M317152


Udvalg og komiteer

Komite

  • CEN/TC 102
  • CEN/TC 102/WG 4

Dansk udvalg

DS/S-259