Uni Iso En 13795

Exten products comply with ISO UNI EN 13795

Discover the new EDANA brochure on single use gowns and drapes!

This brochure is designed to help healthcare professionals evaluate their options in the light of the EN 13795 standard. It was produced on April 2011 by the Medical Devices Committee od EDANA.

(please also refer to Edana & Eorna “Join the fight” campaign)

As component of important medical devices, the laminates for surgical drapes and gowns reinforcement have to comply with EN 13795 requirements.

Thanks to this standard, for the first time, a common reference for all the surgical laminates which applies to single-use products, has been published.

Nonwoven and laminates manufacturers, users, health professionals, processors and test laboratories were represented at each step of the formulation of standard EN 13795 in every state member of the European Committee of Standardisation (CEN). EN 13795 guarantees a performance able to prevent the transmission of infective agents between surgical staff and patients during surgical operations and other invasive procedures; therefore it takes active part in the fight against hospital acquired infections.

Thanks to single-use products’ improvement a higher level of safety and performance is guaranteed.

In the European Union drapes, gowns and clean air suits used in operating theatres are considered medical devices. In fact they live up to the official definition of what a medical device is. Each of those drapes, gowns and clean air suits is:

• a medical article intended to be used for human beings for diagnosis, prevention, monitoring or treatment, among others
• the manufacturer is legally responsible for compliance with the MDD
• the products must meet Essential Requirements on safety, performance and labelling
• the safety requirements are focused on patients

It is important to know that approximately 2 to 5 % of all surgical procedures lead to a postoperative wound infection and that on average, a postoperative wound infection results in 8 and up to 12 additional treatment days with an extra cost of between € 1˙113 and  € 5˙390. Surgical site infection in orthopaedic surgery prolongs the hospital stay by an average of two weeks per patient: this increases health care costs by more than 300%. It is estimated that in the EU alone, healthcare-related infections (HCAI) affect 1 out of 10 patients and roughly 3 million patients in Europe per year are affected by healthcare-related infections (HCAI).