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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/23/2019 Cardiovascular 3-161 Complete 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.
06/07/2021 Cardiovascular 3-166 Partial ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
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 3-172 Complete AAMI TIR42:2021 Evaluation of Particulates Associated with Vascular Medical Devices
12/20/2021 Cardiovascular 3-173 Complete ISO 5840-3 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
12/20/2021 Cardiovascular 3-174 Partial ISO 5840-1 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
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 3-178 Complete ASTM F3067-14 (Reapproved 2021) Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
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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