Standards and regulations

Why CE mark is not printed on the Steriking® pouch, roll or wrap?

According to the EN 868-5:2019 standard it is not allowed to print the CE mark on the sterilization packaging itself. Steriking® pouches, rolls and wraps are not printed with the mark because we are following the EN 868 standard series where it is required to print the CE mark on the transportation/sales packaging.

Why Wipak does not have a CE certificate for Steriking® packaging materials?

Steriking® sterilization packaging materials are classified as Class I products according to the Medical Device Directive, and therefore any certificate for CE marking is not required. However for Class I medical devices manufacturer's EC Declaration of Conformity document need to be issued, and that is available on request.