ASTM's medical device and implant standards are instrumental in specifying and evaluating the design and performance requirements of a number of biomedical materials, tools, and equipments. These apparatuses are used in surgical procedures that involve the placement of such devices to specified parts and structures of the body (both humans and animals) for the purpose of enhancement or as an aid in a disability. These medical device and implant standards allow material and product manufacturers, medical laboratories, and other concerned institutions to inspect and assess such instruments to ensure proper quality and workmanship.

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process