The EN 13795 standard concerns surgical drapes, gowns and surgical gowns, woven or non-woven, and defines the required requirements and the corresponding test methods. This standard was drafted in the spirit of the European regulation which aims to prevent the transmission of infectious agents. It also aims to ensure the same level of safety and performance for all products, whether single-use or reusable.
Which properties should be assessed in EN 13795 ?
- Tensile strength – Wet and dry state – EN 29073-3:1992
- Tear resistance – Wet and dry state – EN 13938-1
- Resistance to liquid penetration – EN 20811
- Microbial cleanliness – EN 1174 (replaced by EN ISO 11737)
- Particulate cleanliness – ISO 9073-10
- Particle release – Linting – ISO 9073-10
- Resistance to microbial penetration – Dry state – ISO 22612
- Resistance to microbial penetration – Wet state – ISO 22610
Protection of the patient or the medical staff ?
On reading document EN 13795, it appears that the standard is oriented towards patient protection; which determines how the sample comes into contact with the infectious agents in the tests.
If the manufacturer also wants to claim protection for nursing staff, surgeons and others, the gown must be considered as PPE (personal protective equipment) and comply with European Regulation relating to PPE 2016/425
The standard to comply with this regulation will then be EN 14126: Protective clothing – Performance requirements and test methods for protective clothing against infectious agents.
Informatively, the EN13795 standard also mentions other interesting properties. Among them, the measurement of comfort, the “Liquid control” or the adhesion properties of the bindings. For the measurement of comfort, Centexbel can help the manufacturer to characterize its product. The possible methods are:
- Skin model – ISO 11092 – EN31092
- Thermal dummy – EN ISO 15831 – ASTM F2370
- Air permeability – ISO 9237
- WP water resistance – ISO 811