Implants regulatory considerations

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. 

The study of the fracture and fatigue properties of UHMWPE materials has received considerable attention over the last 2 decades. The fatigue resistance of UHMWPE is now widely accepted as critical to the structural performance of orthopedic implant bearings, and such data is now commonplace in regulatory approval submissions. With regard to fatigue properties, both the total life (stress analysis based) and defect tolerant (fracture mechanics based) approaches... 

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