What is BS EN 13795-2 about?
BS EN 13795-2 gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent cross contamination between clinical staff and patients; during surgical and other invasive procedures.
BS EN 13795-2 specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements.
Who is BS EN 13795-2 for?
BS EN 13795-2 on clean-air suits (surgical clothing and drapes) is useful for:
- Manufacturers, suppliers, and distributors of surgical clothing and drapes
- Hospitals and other medical facilities
- Quality control personnel
- Health and regulatory bodies
Why should you use BS EN 13795-2?
If you manufacture or use clean air suits, BS EN 13795-2 gives you guidelines for designing, processing, assessing, and selecting these products.
By following BS EN 13795-2 guidelines, you help medical staff to safeguard themselves from the infective agents that they come across, during medical procedures. BS EN 13795-2 guidelines also ensure that there is minimum spread of infective agents to other surgical sites and equipment.
BS EN 13795-2 guides you on the performance requirements as well as design for these clean air suits. BS EN 13795-2 specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.
What’s changed since the last update?
BS EN 13795-2:2019 supersedes both EN 13795-1:2019 and EN 13795:2011+A1:2013, giving some technical changes with respect to EN 13795-1:2019. These include:
- Restriction to the product ‘clean-air suit’
- Revision of performance requirements and manufacturing and processing requirements
- Enhancement and improved structuring of Clause