Subchronic / Chronic Toxicity Testing

Assessing Toxicity of Medical Devices

ISO 10993-11 outlines the general considerations required to assess toxicity of medical devices.  Repeat dose toxicity or continuous dosing over a defined period of time is important to determine the subacute to chronic effects of a device.

These study protocols are developed based on route of patient exposure and contact duration.  The typical routes of administration include intravenous or intraperitoneal injection; however, test articles may be assessed through dermal, ocular or mucosal application.  In addition, device materials may be implanted subcutaneously or intramuscularly.  Longer term studies include hematology, clinical chemistry, necropsy and histopathology.

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If you’re seeking comprehensive medical device services, look no further than iuvo Bioscience. Our experienced team is ready to assist you with testing, evaluation, and regulatory support to ensure successful commercialization of your medical device. Contact us today to discuss your project and learn how our expertise can help you get to market fast.