Standards and regulations

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

It is not forbidden in regulations or in standards 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 Sterile Barrier Association’s recommendation that it is preferable to place the CE mark on the sales packaging rather than on individual packaging, because the printed CE mark in packaging could cause confusion whether the packaging or the packed item is CE marked.

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.