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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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06/07/2018 Biocompatibility 2-250 Complete ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
06/07/2021 Biocompatibility 2-291 Partial ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
07/26/2016 Biocompatibility 2-191 Partial ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ANSI AAMI ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
12/19/2022 Biocompatibility 2-289 Complete ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
12/20/2021 Biocompatibility 2-295 Partial USP-NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test)
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