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Material Characterization for Medical Devices

While biological testing on medical devices will provide clear pass/fail criteria for the tests performed, the material characterization tests will generate data on the potential chemical compounds that can leach out during the medical use of the device under "worst case" simulation conditions. It is clear that the analytical data, generated via a material characterization approach, may need more consideration with regard to the toxicological impact during the use of the device.

Based on its actual relevance, a consortium of Notified Bodies has elaborated a "Code of conduct" as an awareness campaign for medical device manufacturers to file its technical documentation, if necessary combined with analytical testing (extractables studies).

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