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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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04/04/2016 Cardiovascular 3-125 Complete ISO 5841-3 Third edition 2013-04-15 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
12/18/2023 Cardiovascular 3-126 Partial IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]
ANSI AAMI IEC 60601-2-27:2011(R)2016 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
06/07/2021 Cardiovascular 3-129 Partial ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires
06/15/2016 Cardiovascular 3-132 Complete ISO 27185 First edition 2012-02-15 Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
ANSI AAMI ISO 27185:2012 Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
01/14/2019 Cardiovascular 3-138 Complete ASTM F2942-13 Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents
06/27/2016 Cardiovascular 3-143 Partial ISO 12417 First edition 2015-10-01 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
12/23/2016 Cardiovascular 3-144 Complete ISO 7198 Second edition 2016-08-01 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
08/21/2017 Cardiovascular 3-149 Complete ISO 25539-1 Second edition 2017-02 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
06/07/2018 Cardiovascular 3-150 Complete ISO 7199 Third edition 2016-11-15 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
ANSI AAMI ISO 7199:2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
09/17/2018 Cardiovascular 3-153 Complete ASTM F2743-11 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
09/17/2018 Cardiovascular 3-154 Complete ASTM F3211-17 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
07/06/2020 Cardiovascular 3-155 Complete IEC 60601-2-47 Edition 2.0 2012-02 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
ANSI AAMI IEC 60601-2-47:2012/(R)2016 Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
09/17/2018 Cardiovascular 3-156 Complete ISO 14708-1 Second edition 2014-08-15 Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ANSI AAMI ISO 14708-1:2014 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
01/14/2019 Cardiovascular 3-157 Complete ANSI AAMI ISO 25539-1: 2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
01/14/2019 Cardiovascular 3-158 Complete ASTM F3320-18 Standard Guide forCoating Characterization of Drug Coated Balloons
01/14/2019 Cardiovascular 3-159 Partial ISO 5910 First edition 2018-06 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
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.
12/23/2019 Cardiovascular 3-162 Complete ASTM F3374-19 Standard Guide for Active Fixation Durability of Endovascular Prostheses
12/23/2019 Cardiovascular 3-163 Partial ISO 18242 First edition 2016-09-01 Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
07/06/2020 Cardiovascular 3-164 Complete ASTM F1830-19 Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps
07/06/2020 Cardiovascular 3-165 Complete ASTM F1841-19 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
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)]
07/06/2020 Cardiovascular 3-167 Complete ISO TS 81060-5 First edition 2020-02 Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
06/07/2021 Cardiovascular 3-168 Partial IEEE Std 1708-2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
12/21/2020 Cardiovascular 3-169 Partial IEC 60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
ANSI AAMI IEC 60601-2-4:2010/A1:2018 (Consolidated Text) Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
06/07/2021 Cardiovascular 3-170 Complete ISO 14708-5 Second edition 2020-05 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
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 3-175 Complete ISO 5840-2 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
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
12/20/2021 Cardiovascular 3-180 Complete ASTM F3505-21 Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
05/30/2022 Cardiovascular 3-181 Complete ISO 25539-2 Third edition 2020-09 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
05/30/2022 Cardiovascular 3-182 Complete ASTM F3036-21 Standard Guide for Testing Absorbable Stents
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
05/29/2023 Cardiovascular 3-184 Complete ASTM F2477-23 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
05/29/2023 Cardiovascular 3-185 Partial ANSI AAMI PC76:2021 Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
05/29/2023 Cardiovascular 3-186 Complete ISO 14708-2 Third edition 2019-09 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
05/29/2023 Cardiovascular 3-187 Complete ISO 14708-6 Second edition 2019-09 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
05/29/2023 Cardiovascular 3-188 Partial ISO 81060-3 First edition 2022-12 Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type
12/18/2023 Cardiovascular 3-189 Complete ASTM F2942-19 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
12/18/2023 Cardiovascular 3-190 Complete ISO PAS 7020 First edition 2023-05 Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2
05/29/2024 Cardiovascular 3-191 Complete ISO 18242 First edition 2016-09-01 [Including AMD1:2023] Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps [Including AMENDMENT 1 (2023)]
05/29/2024 Cardiovascular 3-192 Complete ISO 22679 First edition 2021-11 Cardiovascular implants - Transcatheter cardiac occluders
08/06/2013 Dental/
ENT		 4-90 Complete ANSI ASA S3.39:1987 (Reaffirmed 2020) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
07/09/2014 Dental/
ENT		 4-97 Complete ANSI ADA Standard No. 57-2000 (R2012) Endodontic Sealing Material
 
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