1 Scope
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.