As medical devices, the surgical textiles have to comply with the European Directive 93/42/EEC. Standard EN 13795 sets out the detailed requirements of this Directive for surgical drapes, gowns and clean air suits in their own application field.
For the first time, a common reference for all the surgical textiles has been published which applies to single-use products as well as reusable products and to be sterilized ones.
All stakeholders (nonwovens manufacturers, reusable materials manufacturers, users, health professionals, processors and test laboratories) were represented at each step of the formulation of standard EN 13795 in every state member of the European Committee of Standardisation (CEN).
In meeting the essential requirements of the European Directive on medical devices, the compliance of a product to standard EN 13795 guarantees a performance that will :
- prevent the transmission of infective agents between surgical staff and patients during surgical operations and other invasive procedures, it takes part in the fight against hospital acquired infections ;
- ensure the same level of safety and performance for all the products throughout their life cycle, whether single-use or reusable products.
