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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Recognition Number: 2-298
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09/07/2026 Biocompatibility 2-298 Partial ISO 10993-18 Second edition 2020-01 Amendment 1 2022-05 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)].
 
 
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