The barrier function of surgical drape materials and surgical scrubs has been scientifically proven. Thus, they represent a sufficiently impenetrable “protective wall” during the strain of an operation between the area afflicted with micro-organisms and the area to be protected, “the wound”. This is necessary, as the skin is never sterile, even after disinfection. Due to this reduced introduction of germs into the wound during an operation which is important for medical reasons, such products are defined as medical devices.

Another point with regard to surgical scrubs is that the personnel also must be protected from infection arising from the patient. Therefore, the provisions of the “Medical Devices Directive” or the national statutory requirements respectively, i.e. Act on Medical Devices, must also be applied to these medical devices.

The quality of medical devices must be verified in order to ascertain their function, not only for the protection of patients, but also of personnel. The various requirements (standard and high performance) depending on mechanical strain, time and use of liquids have been defined by a working group (CEN/TC 205 – WG 14) on the European level, with the co-operation not only of experts from various European countries, but also of delegates from various professional associations, including surgical nurses and surgeons.