scope:

This standard specifies information to be supplied to users and third party verifiers, in addition to the usual labelling of medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements. This standard gives general guidance on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment. It is intended to prevent the transmission of infective agents between patients and clinical staff during invasive surgical procedures. Surgical masks, surgical gloves, packaging materials, foot and head wear and incision drapes are not covered by this standard. This standard does not cover requirements for flammability of products used in laser surgery.