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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Recognition Number: 2-258
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01/14/2019 Biocompatibility 2-258 Partial ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ANSI AAMI ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
 
 
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