DANSK DSF/PREN 13795-1 PDF

This document specifies information to be supplied to users and third-party verifiers in addition to the usual labelling of medical devices (see EN ISO 20417 and EN ISO 15223 1) concerning manufacturing and processing requirements. This document gives information on the characteristics of single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This document specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products. This document does not include information on resistance to penetration by laser radiation of products. NOTE – If resistance to penetration by laser radiation is claimed for surgical drapes, suitable test methods together with an appropriate classification system are given in EN ISO 11810. This document does not cover requirements for incision drapes or films. This document does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment can cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this document with respect to their use as surgical gowns and drapes.