EN 868-8 Packaging for Sterilized Medical Devices - Reusable Sterilization Containers for Steam Sterilizers - Requirements and Test Methods

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.

These containers are designed for use in steam sterilizers conforming to EN 285.

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 products covered by this standard.

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 features of the container are also reviewed for compatibility with the sterilizer cycle.

The use of additional materials or accessories 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 or accessories.

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