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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Standard Designation
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Title of Standard
 
 
08/20/2012 Anesthesiology 1-87 IEC 60601-2-23 Edition 3.0 2011-02 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
06/07/2018 Biocompatibility 2-250 ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
06/07/2021 Biocompatibility 2-291 ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
12/23/2016 Biocompatibility 2-245 ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
09/17/2018 Biocompatibility 2-255 ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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