ISO 10993-18:2020 Chemical Characterization of Medical Device Materials Within a Risk Management Process



The chemical and physical characterization of materials and devices has long been considered an important step in evaluating biological safety. The most recent revisions of ISO 10993-1:2018 and ISO 19003-18:2020 continue to emphasize the importance of this evaluation and potential testing needs.As global regulatory bodies adjust to applying the new ISO 10993-18: 2020, manufacturers must understand the potential nuances of this new regulation. . For example, EU Notified Bodies may require additional evaluation as the Medical Device Regulation (MDR) looms closer, while the U.S. Food & Drug Administration (FDA) has placed an increased emphasis on characterization and requests very specific requirements as outlined in the 2016 guidance document (while continuing to expand the use of the analytical data). The successful implementation of this standard, and evaluation outlined in supporting documents, is critical for medical device manufacturers if they wish to stay on track with market clearance plans.In this 2-part eLearning module, created from the content of NAMSA’s in person workshop, NAMSA experts will discuss the chemical characterization of materials and the evaluation steps to choose proper tests, extracts and test duration to meet the latest industry requirements. This online study will include video of instruction as well as an education evaluation quiz.  Upon successful completion of the module, attendees receive a completion certificate in their grade book.