Ergonomic products that obtained the Ergocert certification, thanks to their anti-bedsore features, were registered by Somnium as class 1 medical devices at the Italian Ministry of Health database. They are certified with the CE certification mark as they meet the so-called “essential requirements” for the safety and effectiveness of both the device and the production, in accordance with the European Union directive on medical devices 93/42/CEE.
The adjective “ergonomic” has become widely adopted but it is often not used properly. In fact, many mattresses associated with this word are not designed with compliance to any ergonomic requirements and there are very few manufacturers who actually make the effort to ensure that their products meet these requirements.
Somnium has had several mattresses of its range evaluated and certified to meet the ergonomic requirements in order to demonstrate their effectiveness. Thanks to lab test performed by Ergocert – Certifying Body for Ergonomics – an academic spin-off of the University of Udine, it was possible to objectively verify and certify the anti-bedsore properties of our mattresses.
Ergocert performed tests on a sample representing a normal distribution of anthropometric characteristics in the population (with particular focus on biological gender and mass body index), in compliance with the requirements of the biomedical technical specification ST-10 for the certification of ergonomics properties of mattresses.
The main parameter for evaluation is the Comfort Index, an objective and scientific numerical value associated with the quality of pressure distribution measured with pressure mapping techniques.
The results achieved are comfortably above the minimum required for the certification, further evidence of the high quality that characterizes Somnium products.