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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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(click for recognition information)
 
05/29/2023 Cardiovascular 3-184 Complete ASTM F2477-23 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
12/19/2022 Cardiovascular 3-183 Complete ISO 11658 First edition 2012-05-15 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
ANSI AAMI ISO 11658: 2012 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
05/30/2022 Cardiovascular 3-181 Complete ISO 25539-2 Third edition 2020-09 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
01/30/2014 Cardiovascular 3-54 Complete ANSI AAMI ISO 7198:2016 Second edition Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches
12/20/2021 Cardiovascular 3-171 Complete ASTM F2514-21 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
12/20/2021 Cardiovascular 3-176 Complete ISO 18193 First edition 2021-08 Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
12/20/2021 Cardiovascular 3-177 Complete ASTM F2606-08 (Reapproved 2021) Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
12/20/2021 Cardiovascular 3-180 Complete ASTM F3505-21 Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
12/20/2021 Cardiovascular 3-172 Complete AAMI TIR42:2021 Evaluation of Particulates Associated with Vascular Medical Devices
12/20/2021 Cardiovascular 3-179 Complete ASTM F3172-15 (Reapproved 2021) Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
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