Customer Service:
Mon - Fri: 8:30 am - 6 pm EST
Back
Standards PDF Cover Page

 Historical

DIN EN 868-5:2009

Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods; German version EN 868-5:2009

This part of EN 868 provides 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 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.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.As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not allof the requirements of EN ISO 11607-1.

Available for Subscriptions

Content Provider
Deutsches Institut für Normung [din]

Others Also Bought

ISO 17100:2015
Translation services - Requirements for translation services
Add to cart
ANSI/AAMI ST35:2003
Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Non-Clinical ...
Add to cart
ISO 10993-1:2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Add to cart
Document History
Revises:
Revised By:
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.
ANSI Logo

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

Useful Links
CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS
2024 © American National Standards Institute (ANSI) All Rights Reserved.