biological evaluation

Extractables and leachables (E/L) have been the prominent subjects over the last decade when discussing the biocompatibility of medical devices. They have stood out like superstar phenomena, presenting both bright spots and shadows. Extractables refer to substances that can be removed from a medical device under laboratory conditions designed to magnify the device's clinical use, while leachables are those substances that could be released from the device in real clinical settings. As an initial approximation, leachables can be considered a subset of extractables.