Biocompatibility - E and L Studies for Medical Device or Combination Products

To ensure patient safety, precise knowledge about potential contamination associated with medical device materials is critical. For this reason, a robust chemical characterization is the first and mandatory step of any biocompatibility study which is performed according to the most recent version of the ISO 10993 guidance. With increasing complexity of medical devices and combination products, the risk of leachables being introduced into the body increases. Depending on the type/class of device, application scenario and contact time, extractables and leachable studies can be divided in different sub-steps to build a comprehensive understanding of the related risks. Several analytical screening techniques should be applied to address all types of potential extractables and leachables - from volatile to non-volatile and from polar to non-polar and from organic to inorganic.

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