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CHEMICAL CHARACTERIZATION AND RECOMMENDED METHODS

December 05, 2019 | (2:00 PM)
USA (United States of America)
Increased awareness of the importance of the physical and chemical properties of medical devices and materials in devices has led to updated requirements in the EU medical device regulation (MDR) and the international ISO 10993-standards for biocompatibility. The requirements recommend the use of physical/chemical characterisation, chemical analyses and toxicological risk assessment in the evaluation of safety. A newly updated version of the ISO 10993-18 on chemical characterisation has been approved by the ISO-committees and is expected to be published soon. Some of the requirements in the new standard is already requested by authorities – challenging industry to provide additional chemical analyses and toxicological data.