Memmert CO₂ incubator ICOmed classified as medical device

In 2016, Memmert had introduced a new generation of its CO₂ incubators at the analytica trade show. Now, about one year later, all products in the ICOmed product range have been classified as medical devices. "Hospitals and medical practices from all around the world that have specialized in in-vitro fertilization are a highly interesting market for Memmert," says Heinz Bayer, Head of Sales at Memmert. In this highly delicate field of application, both medical staff and patients need to be able to fully rely on the precision and reliability of the incubators used. During cultivation, the slightest deviation in the CO₂ atmosphere, temperature or humidity can have a negative influence on cell development. "High clinical success rates directly translate to human joy," notes Bayer.

For that reason, Memmert subjected its CO₂ incubators ICO to an elaborate risk assessment in cooperation with TÜV Rheinland. The classification as a medical device confirms that all Memmert CO₂ incubators ICO comply with the fundamental safety requirements of the European Medical Devices Directive 93/42/EEC.

For many years now, Memmert has had a quality management system in accordance with DIN EN 13485 for the development and manufacturing of medical devices in place. This standard has even more strict requirements on patient and user safety than a certification as per DIN EN 9001. Bayer further points out that "the quality of other products such as heating ovens, incubators, climate chambers and water baths also benefits from these processes that have been especially tailored to our medical devices."