EN 13795

With the ratification of EN 13795, binding standards for the qualification of surgical textiles were put into place for the first time. It provides the ideal precondition for an objective comparison of products and systems. The same qualification procedures apply to all surgical textiles, disposable and reusable products::

• production and provision of products
• characteristics and function of products
• usage and processing of products and
• methods of testing those criteria

The new EN 13795 distinguishes between two categories: standard and high performance. The appropriate limit values of the relevant product characteristics depend on the mode of intervention, operating time, emergence of fluid and mechanical load (for example contact of the surgeons at the operating table). A product has to comply with the set limit values in all areas of the textile to be in accordance with the Medical Devices Law.