Certification in accordance with DIN EN ISO 13485 is proof of high quality – know-how from the automotive sector can now be applied to the medical sector
Albstadt. Shortly before MEDICA commences in November, Karl Küfner AG is able to announce another successful certification. The technology leader for hybrid filter screens with core competences in the manufacture of customer-specific filters, strainers and filters has added another feather to its cap: medical technology. DIN EN ISO 13485 certification means that it is now also a certified manufacturer of medical products.
The successful certification of the owner-managed company, with three sites in Germany and around 300 employees, will enable it to make its extensive expertise in the field of automotive engineering available to customers in the medical sector in the future as well. All in all, Küfner now has a total of three ISO certificates: one for quality management (ISO/TS 16949), one for environmental management (ISO 14001) and the one most recently obtained for the production of medical products (ISO 13485).
The various focal points of medical technology
In the case of ISO 13485 certification, the focus is on the patient and medical personnel rather than the customer. The objective of this standard is to protect patients and personnel from harm. As a result of this, error prevention is the top priority.
The move into the medical sector began more than a year ago with the pledge made by product specialist Rolf Brenner, Head of the Non Automotive Division and Medical Technology.
Küfner has gained a foothold in this market segment by developing applications for the filtration of liquids and gases used in anesthesia. The areas of application for custom-developed screens, strainers and filters from Küfner are
• Intensive care / anesthesia / mechanical venti-lation
• Disinfection / sterilization
• Emergency services / emergency medicine
• Medical treatment
A range of devices and applications means that a range of demands are made of filtration in the medical sector. Specialized filters must therefore be used in order to guarantee
• safe medical procedures,
• fail-safe function and
• efficient operation of devices.
Küfner is able to develop and supply such filters in order to meet the requirements of customer-specific applications.