Toxicology & Applied Science

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Toxicology & Applied Science

Toxicology & Applied Science

Tag: Chemical analytical testing

Chemical analytical testing of medical devices, primarily driven by biocompatibility standards like ISO 10993-18, involves analyzing materials to identify and quantify potential extractable and leachable substances. This testing ensures patient safety and regulatory compliance by predicting and mitigating toxicity risks from material additives and manufacturing impurities that could migrate into the patient during device use. Key services include extractables and leachables testing, material fingerprinting, and toxicological assessment to confirm that the device’s chemical properties do not pose unacceptable risks.

Safety risk categorization for organic extractables and manufacturing aid constituents

Medical matters has developed a risk management (RM) tool that allows to calculate risk scores for chemical constituents. Risk scores are based amongst others on a constituent’s physicochemical properties and its quantitative structure-activity relationship (QSAR) assessment outcomes. Risk scores therefore reflect the patient safety risk posed by a detected leachable/extractable or any other constituent, by consideration of […]

CDRH publishes dataset to help improve chemical characterization methods

The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has published a dataset intended to help analytical laboratories demonstrate their ability to detect a broad range of chemicals that may be encountered in a non-targeted analysis as part of a comprehensive extractables/leachables program. The dataset contains a list of over […]