Abstract / scope
This document gives information on the characteristics and performance requirements for surgical drapes, surgical gowns, and equipment covers used as medical devices for the purpose to create a sterile field, that are labelled with barrier performance claims and intended to minimize the transmission of infective agents between patients and clinical staff in health care facilities (e.g., single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment).
This standard specifies the following concerning the manufacturing and processing of the products specified above:
- test methods for evaluating the characteristics as identified in this document;
- performance requirements for these products;
- information to be supplied to users and third parties, for instance proper verifier authorities.