Implantable medical devices mitigation

Medical device. Any instrument, apparatus, implant, machine, in vitro reagent, contrivance, implement, or other similar or related article, including any part, component, or accessory, which is intended for application in diagnosing diseases or other conditions or in the treatment, mitigation, prevention, or cure of disease or intended to affect the structure or any function of the body. 

To mitigate the risk of applying a device to the human body, a series of tests such as those guided by the International Organization of Standards (ISO), are required to be performed on the device prior to human use. Biocompatibility evaluation of medical devices, based on the ISO 10993, is performed to determine the potential harmful effects from contact of the component materials with the body. BiocompatibiUty tests also evaluate the fitness and function of the devices under an implant environment. It should be noted that requirements of biocompatibility vary considerably based on the device function and design, so most regulatory evaluations are device-orientated rather than material-orientated. Usually, materials that have been proven to be biocompatible in one device have to be reevaluated for a different application. 

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