In the NAMSA’s website, it is stated that the biological safety testing or evaluation is conducted by characterizing medical devices based on nature and duration of body contact, assessing the selection of raw materials used for construction, reviewing the manufacturing processes, identifying minimum biological end-points of concern and evaluating any existing research data available for addressing the areas of biological risks.
Biological Safety test for a medical device is to address potential risks of the device to a patient which concentrated on the areas on the materials and manufacturing process for the device. as well as the Risk Assessment, Toxicological Assessment, and biocompatibility. The main three steps involved in the biological safety test are the nature of the body contact, duration of contact and Situational risks. the biological safety test has been conducted as part of the biological evaluation of medical devices in line with the series of standards standard En ISO 10993 -1: 2009/AC:2010.