EN ISO 10993-16 provides principles for the design and implementation of toxicokinetic studies of medical devices. Explain the considerations regarding the inclusion of toxicokinetic studies in the biological evaluation of medical devices.
The results of leaching studies should be taken into account to determine the methods to be used in toxicokinetic studies. Information on the chemical and physicochemical properties, the surface morphology of the material, and the biochemical characteristics of any leaks should also be considered.
It is recommended to perform toxicokinetic studies with a characterized leachate or decomposition product with the potential to be toxic. However, the performance of toxicokinetic studies on mixtures is possible under certain conditions. An extract liquid or a ground or powdered form of the material or device may be used in exceptional circumstances and should be justified in the study design.
The work should be done in an appropriate gender and species. Healthy young adult animals should be acclimatized to laboratory conditions for at least 7 days. When used, they must be transferred to individual metabolism cages for a period of acclimatization of at least 24 hours. Environmental conditions should be as recommended in the guidelines for the care and use of animals. During the study, conventional animal diets and drinking water should be freely available, unless otherwise specified in the protocol.
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