The three major material classes used in devices — metals, polymers, and ceramics — and the ISO 10993 biocompatibility framework that governs contact duration and contact type testing.
This module surveys the three biomaterial classes that dominate medical device construction: metals such as Ti-6Al-4V titanium alloy and cobalt-chromium, chosen for load-bearing implants because of their fatigue resistance and, in titanium's case, an elastic modulus far closer to cortical bone than steel's; polymers such as PEEK, UHMWPE, silicone, and PMMA, chosen for their processability and, in some cases, radiolucency; and ceramics such as alumina and zirconia, chosen where extreme wear resistance and chemical inertness matter more than fracture toughness.
It then builds the ISO 10993 biocompatibility framework that governs how any of these materials must be tested before contacting patient tissue — organized around contact duration (limited, prolonged, or permanent) and contact type (surface, external communicating, or implant) — and the risk-based, chemical-characterization-first approach that increasingly lets a well-documented chemistry argument reduce or replace some biological testing rather than defaulting to the full battery for every device.