The practice of evaluating a medical device’s compatibility with biological systems and tissues is known as biocompatibility testing. It guarantees that the equipment is safe for patients to use and is an essential step in the regulatory approval process for medical devices.
Biocompatibility testing is a critical part of medical device development and approval. Regulatory agencies like the FDA (Food and Drug Administration) and ISO (International Organization for Standardization) require these tests to confirm that medical devices are safe for their intended use. Failing to meet these standards can lead to device recalls, patient harm, and financial loss.
Evaluates whether the material or device is toxic to cells. This test involves exposing cultured cells to the material and observing the response.
Assesses whether a material will cause an allergic reaction. Sensitization tests are critical for materials that come in direct contact with the skin or mucosal surfaces.
Biocompatibility testing must meet the guidelines and regulations set by authorities such as:
