Χειρουργικά καλύμματα, ποδιές και ενδυμασίες χώρων καθαρού αέρα που χρησιμοποιούνται ως προϊόντα για ιατρική χρήση για ασθενείς, κλινικό προσωπικό και εξοπλισμό - Γενικές απαιτήσεις για κατασκευαστές, μεταποιητές και προϊόντα, μέθοδοι δοκιμής, απαιτήσεις επίδοσης και επίπεδα επίδοσης

This European 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 European Standard gives information 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, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products. EN 13795 does not cover requirements for flammability of products. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and EN ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.