The biocompatibility evaluation of liquids, creams, gels and other non-solid medical devices

The biocompatibility evaluation of medical devices is governed by standards, guidance documents and other regulations from around the world. These include, but are not limited to, International Organization for Standardization (ISO) 10993; U.S. Food and Drug Administration (FDA) guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'"; various ASTM standards; and others. These standards and guidance documents include plans for how to perform a risk-based evaluation of medical devices for biocompatibility, along with methods for how to perform testing. These methods are both for when medical devices must be extracted and when direct application testing is appropriate.