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Center for Devices and Radiological Health (2020) Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process. U.S. Food and Drug Administration, Silver Spring, 51-54.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and

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