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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Date of
Recognition
 
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Standard Designation
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Title of Standard
 
 
12/23/2019 Anesthesiology 1-102 ISO 80601-2-69 First edition 2014-07-15 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
12/23/2019 Anesthesiology 1-145 ISO 19223 First edition 2019-07 Lung ventilators and related equipment - Vocabulary and semantics.
12/23/2019 Biocompatibility 2-269 USP 42-NF37:2019 <87> Biological Reactivity Test, In Vitro - Direct Contact Test
12/23/2019 Biocompatibility 2-270 USP 42-NF37:2019 <87> Biological Reactivity Test, In Vitro - Elution Test
12/23/2019 Biocompatibility 2-271 USP 42-NF37:2019 <88> Biological Reactivity Tests, In Vivo
12/23/2019 Biocompatibility 2-272 USP 42-NF37:2019 <151> Pyrogen Test (USP Rabbit Test)
12/23/2019 Cardiovascular 3-161 ISO 14117 Second edition 2019-09 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices.
12/23/2019 Cardiovascular 3-162 ASTM F3374-19 Standard Guide for Active Fixation Durability of Endovascular Prostheses
12/23/2019 Cardiovascular 3-163 ISO 18242 First edition 2016-09-01 Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps.
12/23/2019 Dental/
ENT
4-260 ANSI ASA S12.2-2019 American National Standard Criteria for Evaluating Room Noise
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