BS EN 13795-1 is one of a series of documents on surgical clothing and drapes. It specifies the requirements and test methods for surgical drapes and gowns. BS EN 13795-1 specifies information to be supplied to users and third-party verifiers, in addition to the usual labelling of medical devices.
Also, BS EN 13795-1 gives information about the characteristics of single-use as well as reusable surgical gowns and surgical drapes that are used as medical devices for patients, clinical staff, and equipment. The guidelines given in BS EN 13795-1 help you to prevent cross contamination between clinical staff and patients during surgical and other invasive procedures.
BS EN 13795-1 on surgical drapes and gowns is useful for:
When dealing with patients, medical staff can be exposed to contaminants. To safeguard staff, it is important that the quality of their medical gowns and equipment adheres to safety standards. BS EN 13795-1 provides you with guidelines to prevent the transmission of infective agents across clinical staff and patients.
BS EN 13795-1 also helps you to design, process, assess, and select products; to ensure the same level of safety from single-use or reusable surgical clothing.
BS EN 13795-1:2019 supersedes EN 13795:2011+A1:2013, including some technical changes with respect to EN 13795:2011+A1:2013. The primary change is that the product ‘clean-air suit’ has been moved to Part 2 of the EN 13795 standard series, because of its distinctive requirements and test methods.
EN 13795-1:2019