Standard EN 13795 applies to single-use products, reusable products and “to be” sterilized products.
This includes (sterile or non-sterile) :
- surgical drapes,
- surgical gowns,
- clean air suits.
for :
- patients,
- staffs,
- equipment.
Standard EN 13795 aims to help all stakeholders: manufacturers, test laboratories and users during the design, manufacturing, assessment and selection of these products. Standard EN 13795 does not apply to the following products :
- caps,
- surgical masks,
- surgical gloves,
- packaging materials,
- incision drapes,
- drapes used in laser surgery.
Standard EN 13795 is a European standard. Since its publication, it has automatically become a national standard with the same contents in the 28 European countries who are members of the European Committee of Standardisation. The French reference for this standard is NF EN 13795.
