Certified according to DIN EN ISO 10993-5
CERATIZIT S.A., Mamer (Luxembourg), 17 December 2019
The CERATIZIT Group is now offering its customers in the medical industry 15, DIN EN ISO 10993-5-certified, non-cytotoxic carbide and cermet grades for biocompatible medical and dental tools. Testing for in-vitro cytotoxicity was carried out by the accredited testing laboratory Creamedix GmbH.
For more than 30 years, CERATIZIT has been supplying the medical industry with both standard and customer-specific products based on its own specially-developed carbide grades. CERATIZIT’s carbide and cermet solutions are vastly superior to standard steel products thanks to their extreme hardness, toughness, breakage resistance, temperature and corrosion resistance. However, in the field of medical products, it’s not only performance that plays a role – patient safety is also key, and must be guaranteed at all costs.
The customer saves both time and money
Therefore, in the future, new EU legislation will require the certification of all medical products for biocompatibility. For CERATIZIT’s customers, the certification of non-cytotoxic carbide and cermet grades represents a monetary advantage against this background, as explained by Development Engineer Dr Michael Dröschel: “With our materials that are already certified to DIN EN ISO 10993-5, we are removing an important obstacle in the certification of our customers’ end products, thus saving them time and money”.
The CERATIZIT Group worked together with Creamedix GmbH in Weingarten (Baden) for the certification of the new materials. The ISO 17025-accredited bioanalytics laboratory specialises in the testing of medical products and their source materials for biocompatibility according to ISO 10993, and, in particular, in-vitro based analysis systems as an alternative to animal models.
Wide product spectrum
With the new grades, CERATIZIT covers a wide spectrum of products. Whether a standard stock product or a tailor-made blank, CERATIZIT supplies specific carbide grades for a wide range of applications in the medical technology industry: from tools such as drills and dental burs to needle holder plates, through to forceps and much more.
The products are suitable for a broad range of applications, such as bones, tissue and tendons as well as for titanium, metal alloys, and ceramics. Thanks to their many years of experience and know-how along the entire product chain from powder to the final product, CERATIZIT’s experts can also offer the best advice on individual solutions.
Additional information on the DIN EN ISO10993 5-certified carbide and cermet grades can be accessed via the following link: