EN 868-4 Packages for Sterilized Medical Devices - Test for Paper Bags

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN 868-4 testing. This standard provides test methods and values ​​for paper bags made from paper used as sterile barrier systems or packaging systems intended to maintain the sterility of finally sterilized medical devices until the point of use.

The need for protective packaging can be determined by the manufacturer and the user.

This part of EN 868 only presents the performance requirements and test methods specific to the products covered by this part of EN 868, but does not add or replace the general requirements set out in EN ISO 11607-1.
Therefore, the specific requirements in 4.2 to 4.6 can be used to demonstrate compliance with one or more, if not all, of the requirements of EN ISO 11607-1.

The materials specified in this part of EN 868 are for single use only.

When additional materials are used within the sterile barrier system to facilitate organization, drying, or aseptic presentation (e.g., inner wrap, container filter indicators, packing lists, mats, instrument organizer kits, tray liners, or an additional envelope around the medical device), then during validation activities Other requirements may apply, including determining the acceptability of these materials.

EUROLAB assists manufacturers with EN 868-4 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.