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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
12/21/2020 Biocompatibility 2-286 USP 43-NF38:2020 <88> Biological Reactivity Tests, In Vivo
12/21/2020 Biocompatibility 2-287 USP 43-NF38:2020 <151> Pyrogen Test (USP Rabbit Test)
12/21/2020 Biocompatibility 2-288 ISO 10993-15 Second edition 2019-11 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
01/14/2019 Cardiovascular 3-44 ANSI AAMI BP22:1994 (R2016) Blood pressure transducers
01/14/2019 Cardiovascular 3-52 ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes
01/30/2014 Cardiovascular 3-54 ANSI AAMI ISO 7198:2016 Second edition Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches
01/14/2019 Cardiovascular 3-55 ASTM F1830-97 (Reapproved 2017) Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps
01/14/2019 Cardiovascular 3-56 ASTM F1841-97 (Reapproved 2017) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps egg
01/30/2014 Cardiovascular 3-63 ISO 11318:2002 Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements.
01/14/2019 Cardiovascular 3-66 ASTM F2081-06 (Reapproved 2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
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