Advising on biocompatibility of medical devices
We provide interpretation of inhalation toxicity data relevant to breathing gas pathways for your device per ISO 10993-17 and ISO/TS 21726:2019. The evaluation is mostly performed in conjunction to the measurements according to 18562-2, and -3.
Please also see Biocompatibility Evaluation of Breathing Gas Pathway Devices according to ISO 18562-2 and ISO 18562-3
For more information, please contact
Lars-Magnus Bjursten, MD, PhD
Senior Adviser – Biocompatibility Evaluation of Medical Devices
Dr. Bjursten is senior professor at Lund University, Bioimplant research and affiliated professor at UCSD (University of California San Diego, Dept. for Bioengineering) He is board certified specialist in internal medicine as well as clinical immunology and transfusion medicine. He has been working in the international ISO TC 194 committee that is developing the ISO 10993 series of standards for more than 25 years and is chairman of the Swedish mirror committee for 20 years. Dr. Bjursten has been actively involved in the development of the ISO 18562 series of standards (Biocompatibility evaluation of breathing gas pathways in healthcare applications) and is currently the convener for the TC 121/SC3/WG13 that is responsible for the revision of the 18562 series of standards. He has for 20 years been consultant to industry in biological safety evaluation and risk management of medical devices and been in the SCENIHR (Scientific Committee on Emerging and Newly Identified Risks in EU) working group on Guidance on the Determination of Potential Health Effects of Nano materials Used in Medical Devices.