EN 868-8 Packages for Sterilized Medical Devices - Test for Steam Sterilizers

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN 868-8 testing. This standard specifies test methods and values ​​for reusable containers used as sterile barrier systems aimed at maintaining the sterility of finally sterilized medical devices up to the point of use.

The necessity of a packaging material inside the container is determined by the manufacturers and users.

Except for the general requirements specified in EN ISO 11607 1 and EN ISO 11607 2, this part of EN 868 specifies materials, test methods and values ​​specific to the products covered by this document.

When containers are intended to be used in a steam sterilizer that does not comply with EN 285, the sterilization performance of the container is verified by the user in the specific sterilization cycle to be used. Other characteristics of the container are also reviewed for compatibility with the sterilizer cycle, eg operating temperature.

The use of additional materials and/or accessories (eg medical device) within the sterile barrier system to facilitate organization, drying or aseptic presentation is not covered in this part of EN 868. However, other requirements may apply during validation activities, including determining the acceptability of these materials and/or accessories.

EUROLAB assists manufacturers with EN 868-8 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.