Every medical device on the market must be evaluated for its potential to cause irritation, from a knee brace to an artificial cardiac pacemaker, regardless of whether it has a short-term or long-term exposure to the user/patient. This is a requirement set forth in International Organization for Standardization (ISO) 10993-1:2018: Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. This standard requests manufacturers to evaluate the safety of a medical device to ensure it is manufactured using materials and processes that will not cause an adverse response (that is, for example, irritation, allergy, fever, inadvertent weight loss) when used in a clinical setting.
