Have you considered the risks of hemolysis and thrombosis as well as the impact of any changes in manufacturing and processing parameters? Many commonly used medical devices, such as catheters, cardiopulmonary bypass systems, and endovascular grafts, are intended to come in contact with circulating blood. Therefore, these devices require an assessment for hemocompatibility risks such as hemolysis and thrombosis prior to submitting to a regulatory agency for market approval. The testing required for the evaluation of these specific endpoints depends on the exposure type and duration of the specific medical device under focus, and the guidance is captured in Table 1 of ISO 10993-4 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood.

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