The growing field of nanotechnology requires implementations of new protocols to complement these new medical device technology advances. Improvements to medical devices using nanotechnology “may increase the effectiveness of implantation, drug release, targeting specific organs, or data transmission from an implant.” For example, many drug delivery devices have been reduced in size to the nanoscale to effectively target specific organs and tissues, while rapidly or gradually releasing treatment agents. The current standards set forth by ISO 10993, however, very sporadically address the testing of medical devices, which include nanoparticles.
ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management and ISO/TR 10993-22 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials do an excellent job of providing a general framework on how we should begin assessing nanotechnology. Nevertheless, both lack a specific framework for considering the difficulties associated with testing devices on a nanoscale. Furthermore, because “nanoparticles will most likely be distributed within the body using the circulatory or the lymphatic system where they are expected to be engulfed by cells of the mononuclear phagocytic system (macrophages, dendritic cells, or Langerhans cells),” immunotoxicity will need to be carefully considered. Lastly, since some nanoparticles will distribute throughout the body, thus ISO 10993-6 Biological evaluation of medical devices – Part 6: Tests for local effects after implantation fails to account for these new devices across the body. “Nanoparticles or devices containing nanomaterials, the development of a biological evaluation plan as an initial risk assessment (although always recommended as a primary stage for any type of device) is vital to accurately assess the biological risks associated with them.”
Click here to view the full article. For more information about nanotechnology, read ISO/TR 10993-22:2017, ISO/TS 80004-1:2015, and/or ISO/TR 18401:2017.
